Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03446573
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 743
• Locations: 133
• Arms: 2
• Actual Duration (Months): 51.4
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult participants with current virologic suppression on a >=3-drug tenofovir alafenamide (TAF) based regimen (TBR) remain suppressed upon switching to a two-drug regimen of dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg. This study will also provide important information regarding the safety and participant satisfaction with this two-drug regimen. The primary objective of this trial is to demonstrate the non-inferior antiviral activity of switching to DTG + 3TC once daily compared to continuation of TBR over 48 weeks in HIV-1 infected, antiretroviral therapy (ART)-experienced, virologically suppressed participants. This study also will characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC compared to TBR through Week 144 and characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC through Week 200.

This will be a 200-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel- group study. The study will include a screening phase (up to 28 days), a randomized early switch phase (Day 1 up to Week 148), a randomized late switch phase (Week 148 up to Week 200), and a continuation phase (post Week 200). HIV-1 infected adults on stable TBR will be randomized 1:1 to switch to DTG + 3TC once daily for up to 200 weeks, or to continue their TBR for 148 weeks, at which time and if HIV-1 ribonucleic acid (RNA) <50 copies per milliliter (c/mL) at Week 144, these participants will switch to DTG + 3TC up to Week 200.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Drug: DTG + 3TC; Drug: TAF based regimen (TBR)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 743 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a randomized study with parallel group assignment where participants will be randomized into one of the two treatment groups. Participants randomized to DTG + 3TC will receive DTG + 3TC up to Week 200. Participants randomized to TBR will continue to take their current regimen up to Week 148, at which time and if HIV-1 RNA <50 c/mL at Week 144, these participants will switch to DTG + 3TC up to Week 200. Randomization will be stratified by Baseline third agent class (protease inhibitor [PI], integrase inhibitor [INI], or non-nucleoside reverse transcriptase inhibitor [NNRTI]).This is a randomized study with parallel group assignment where participants will be randomized into one of the two treatment groups. Participants randomized to DTG + 3TC will receive DTG + 3TC up to Week 200. Participants randomized to TBR will continue to take their current regimen up to Week 148, at which time and if HIV-1 RNA <50 c/mL at Week 144, these participants will switch to DTG + 3TC up to Week 200. Randomization will be stratified by Baseline third agent class (protease inhibitor [PI], integrase inhibitor [INI], or non-nucleoside reverse transcriptase inhibitor [NNRTI]).
• Masking: None (Open Label)
• Masking Description: This will be an open-label study and therefore no blinding is required. No summaries of the study data according to actual randomized treatment groups will be available to sponsor staff prior to the planned Week 24 preliminary analysis.
• Primary Purpose: Treatment
• Official Title: A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed
• Actual Study Start Date: Jan 18, 2018
• Actual Primary Completion Date: May 20, 2019
• Actual Study Completion Date: May 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DTG + 3TC 50 mg/300 mg Participants will receive a single tablet of a two-drug regimen of DTG 50 mg + 3TC 300 mg once daily from Day 1 through Week 200 (Early and Late Switch Phase).	Drug: DTG + 3TC; DTG+3TC is supplied as white, oval, film-coated, fixed dose combination tablet. The tablets will be available in packed high density polyethylene (HDPE) bottles with induction seals and child-resistant closures.
Active Comparator: TAF based regimen (TBR) Participants will continue their TBR from Day 1 to Week 148 (Early Switch Phase), and eligible participants will switch to DTG + 3TC once daily from Week 148 to 200 (Late Switch Phase).	Drug: TAF based regimen (TBR); Participants will continue to receive their TBR.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48 [Week 48]

   Percentage of participants with virologic failure (plasma HIV-1 RNA >=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who receive at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized.

Secondary Outcome Measures

1. Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48 [Week 48]

   Percentage of participants with plasma HIV-1 RNA <50 c/mL (virologic success) was evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.

2. Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24 [Week 24]

   Percentage of participants with plasma HIV-1 RNA >=50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.

3. Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144 [Weeks 96 and 144]

   Percentage of participants with plasma HIV-1 RNA >=50 c/mL are planned to be evaluated using FDA snapshot algorithm at Weeks 96 and 144. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

4. Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24 [Week 24]

   Percentage of participants with plasma HIV-1 RNA <50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.

5. Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144 [Weeks 96 and 144]

   Percentage of participants with plasma HIV-1 RNA <50 c/mL are planned to be evaluated using FDA snapshot algorithm at Weeks 96 and 144. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

6. Change From Baseline in CD4+ Cell Count at Weeks 24 and 48 [Baseline (Day 1) and at Weeks 24 and 48]

   CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

7. Change From Baseline in CD4+ Cell Count at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

   CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples are planned to be collected at specified time points to assess CD4+. It is planned to be evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

8. Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48 [Baseline (Day 1) and at Weeks 24 and 48]

   Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over 48 Weeks. Baseline (Day 1) values were the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable .

9. Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

   Blood samples are planned to be collected at specified time points to assess CD4+/CD8+ cell count ratio. It is planned to be assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over Weeks 96 and 144. Baseline (Day 1) values are the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

10. Number of Participants With Disease Progression at Weeks 24 and 48 [At Weeks 24 and 48]

    HIV-associated conditions were recorded during the study and was assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV were: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: >=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: with HIV infection and CD4+ T-lymphocye count <200 cells/mcL. Disease progression summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death.

11. Number of Participants With Disease Progression at Weeks 96 and 144 [At Weeks 96 and 144]

    HIV-associated conditions are planned to be recorded during the study and assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV is: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: >=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: with HIV infection and CD4+ T-lymphocye count <200 cells/mcL. Indicators of clinical disease progression is defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

12. Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48 [Up to Week 48]

    An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Safety Population included all participants who received at least one dose of study treatment either DTG + 3TC or TBR. This population was based on the treatment the participant actually received. Number of participants with any SAE and common (>=2%) non-SAEs are presented.

13. Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 144 [Up to Week 144]

    An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

14. Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48 [Up to Week 48]

    An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Number of TDF-based regimen participants with any SAE and common (>=2%) non-SAEs are presented.

15. Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 144 [Up to Week 144]

    An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

16. Number of Participants With AEs by Their Severity Grades: Up to Week 48 [Up to Week 48]

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.

17. Number of Participants With AEs by Their Severity Grades: Up to Week 144 [Up to Week 144]

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events are planned to be evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

18. Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 [Up to Week 48]

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of TDF-based regimen participants with adverse events by maximum grade have been presented.

19. Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 144 [Up to Week 144]

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events are planned to be evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

20. Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48 [Up to Week 48]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.

21. Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144 [Up to Week 144]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

22. Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48 [Up to Week 48]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.

23. Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 144 [Up to Week 144]

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

24. Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 [Up to Week 48]

    Blood samples were collected up to Week 48 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.

25. Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 [Up to Week 144]

    Blood samples are planned to be collected up to Week 144 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters are planned to be evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

26. Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 [Up to Week 36]

    Blood samples were collected up to the Week 36 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those TDF-based regimen participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.

27. Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 [Up to Week 144]

    Blood samples are planned to be collected up to the Week 144 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters are planned to be evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

28. Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 [Up to Week 48]

    Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.

29. Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 [Up to Week 144]

    Blood samples are planned to be collected up to Week 144 for the analysis of clinical chemistry parameters: ALT, albumin, ALP, AST, bilirubin, CO2, cholesterol, CK, creatinine, direct bilirubin, GFR from creatinine adjusted for BSA, GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, LDL cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters are planned to be evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

30. Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 [Up to Week 36]

    samples were collected up to the Week 36 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.

31. Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 [Up to Week 144]

    Blood samples are planned to be collected up to Week 144 for the analysis of clinical chemistry parameters: ALT, albumin, ALP, AST, bilirubin, CO2, cholesterol, CK, creatinine, direct bilirubin, GFR from creatinine adjusted for BSA, GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, LDL cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters are planned to be evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

32. Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 [Baseline (Day 1) and at weeks 24 and 48]

    Urine samples were collected at Baseline, Week 24 and Week 48. Baseline is defined as Day 1. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. Change from Baseline in UP/C and UA/C was calculated as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio calculated at Baseline, respectively. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

33. Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    Urine samples are planned to be collected at Baseline, Weeks 96 and 144. Baseline is defined as Day 1. Change from Baseline in UA/C is defined as UA/C ratio at post-Baseline visit minus UA/C ratio at Baseline. Change from Baseline in UP/C and UA/C is defined as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio at Baseline, respectively. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

34. Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen [Baseline (Day 1) and at weeks 24 and 48]

    Urine samples were collected at Baseline, Week 24 and Week 48 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Change from Baseline in UP/C was calculated as UP/C ratio at post-Baseline visit minus UP/C ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

35. Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 in Participants Randomized to TBR Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 96 and 144]

    Urine samples are planned to be collected at Baseline, Weeks 96 and 144 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline in UA/C is defined as UA/C ratio at post-Baseline visit minus UA/C ratio at Baseline. Change from Baseline in UP/C is defined as UP/C ratio at post-Baseline visit minus UP/C ratio at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

36. Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 [Baseline (Day 1) and at weeks 24 and 48]

    Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine beta-2 microglobulin/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

37. Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    Urine biomarker samples are planned to be collected at Baseline, Weeks 96 and 144 to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine is defined as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

38. Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at weeks 24 and 48]

    Urine biomarker samples were collected to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

39. Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 96 and 144]

    Urine biomarker samples are planned to be collected at Baseline, Weeks 96 and 144 to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine is defined as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

40. Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 [Baseline (Day 1) and at weeks 24 and 48]

    Urine biomarker samples were collected at Baseline and at Weeks 24 and 48 to assess urine phosphate. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

41. Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    Urine biomarker samples are planned to be collected at Baseline, Weeks 96 and 144 to assess urine phosphate. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate is defined as urine phosphate at post-Baseline visit minus urine phosphate at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

42. Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at weeks 24 and 48]

    Urine biomarker samples were collected to assess urine phosphate. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

43. Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 96 and 144]

    Urine biomarker samples are planned to be collected to assess urine phosphate. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate is defined as urine phosphate at post-Baseline visit minus urine phosphate at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

44. Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 [Baseline (Day 1) and at weeks 24 and 48]

    Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine retinol binding protein 4/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio was calculated as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

45. Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    Urine biomarker samples are planned to be collected at Baseline, Weeks 96 and 144 to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio is defined as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

46. Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at weeks 24 and 48]

    Urine biomarker samples were collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine was calculated as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

47. Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 96 and 144]

    Urine biomarker samples are planned to be collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine is defined as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

48. Change From Baseline in Fasting Lipids at Weeks 24 and 48 [Baseline (Day 1) and at weeks 24 and 48]

    Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma high density lipoprotein (HDL) cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

49. Change From Baseline in Fasting Lipids at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    Blood samples are planned to be collected at Baseline (Day 1), Weeks 96 and 144 to assess fasting lipids which includes plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value is the value from the latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

50. Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at weeks 24 and 48]

    Blood samples were collected at Baseline (Day 1), weeks 24 and 48 visit (participant withdrew from the study at Week 36) to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for fasting lipids in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

51. Change From Baseline in Fasting Lipids at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 96 and 144]

    Blood samples are planned to be collected to assess fasting lipids which includes plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value is the value from the latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

52. Number of Participants With Genotypic Resistance: Up to Week 48 [Up to Week 48]

    Plasma samples were collected for drug resistance testing. Number of participants, who met confirmed virologic withdrawal (CVW) criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with emergent genotypic resistance to INSTI, nucleoside reverse transcriptase inhibitor (NRTI), NNRTI and PI was summarized.

53. Number of Participants With Genotypic Resistance: Up to Week 144 [Up to Week 144]

    Plasma samples are planned to be collected for drug resistance testing. Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with emergent genotypic resistance to INSTI, NRTI, NNRTI and PI are planned to be summarized. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

54. Number of Participants With Phenotypic Resistance: Up to Week 48 [Up to Week 48]

    Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented.

55. Number of Participants With Phenotypic Resistance: Up to Week 144 [Up to Week 144]

    Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with emergent phenotypic resistance to INSTI and/or NRTI are planned to be summarized. Assessment of antiviral activity of ART using phenotypic test results are planned to be interpreted through a proprietary algorithm (from Monogram Biosciences), which provides the overall susceptibility of the drug. Partially sensitive and resistant calls are considered resistant in this analysis. The phenotypic resistance is planned to be calculated using binary scoring system, where 0 is considered as sensitive and 1 as resistance. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

56. Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 [Baseline (Day 1) and at Weeks 24 and 48]

    Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, body mass index (BMI) (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

57. Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    Serum samples are planned to be collected for analysis of bone biomarkers. Baseline is latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

58. Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48 [Baseline (Day 1) and at Weeks 24 and 48]

    Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Change from Baseline in bone biomarkers-serum bone-specific ALP (Bone-ALP), osteocalcin, serum P1NP and serum CTX-1 in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

59. Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    Serum samples are planned to be collected for analysis of bone biomarkers. Baseline is latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

60. Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 [Baseline (Day 1) and at Weeks 24 and 48]

    Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value was latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

61. Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    Serum samples are planned to be collected for analysis of 25-hydroxyvitamin D. Baseline value is latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

62. Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 24 and 48]

    Serum samples were collected for the analysis of 25-hydroxyvitamin D. Baseline value was the value from latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum 25-hydroxyvitamin D in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

63. Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 96 and 144]

    Serum samples are planned to be collected for the analysis of 25-hydroxyvitamin D. Baseline value is the value from latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

64. Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 [Baseline (Day 1) and at Weeks 24 and 48]

    Serum samples were collected to assess renal biomarker. Baseline was latest pre-dose assessment value (Day 1) with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for following:treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

65. Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    Serum samples are planned to be collected to assess renal biomarker. Baseline is latest pre-dose assessment value (Day 1) with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

66. Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 24 and 48]

    Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - cystatin C. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum cystatin -C biomarker in TDF based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

67. Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 96 and 144]

    Serum samples are planned to be collected at Baseline, Weeks 96 and 144 to assess renal inflammation biomarker - cystatin C. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

68. Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 [Baseline (Day 1) and at Weeks 24 and 48]

    Serum samples were collected to assess serum GFR from cystatin C and from creatinine adjusted using CKD-EPI. Baseline was Day 1 with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

69. Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    Serum samples are planned to be collected to assess serum GFR from cystatin C and from creatinine adjusted using CKD-EPI. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

70. Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 24 and 48]

    Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarkers - serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

71. Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 96 and 144]

    Serum samples are planned to be collected at Baseline, Weeks 96 and 144 to assess renal inflammation biomarkers - serum GFR from cystatin C and from creatinine adjusted using CKD-EPI. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

72. Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 [Baseline (Day 1) and at Weeks 24 and 48]

    Serum samples were collected to assess renal inflammation biomarker - serum creatinine. Baseline was Day 1 with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

73. Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    Serum samples are planned to be collected to assess renal inflammation biomarker - serum creatinine. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

74. Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 24 and 48]

    Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - serum creatinine. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum creatinine in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

75. Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen [Baseline (Day 1) and at Weeks 96 and 144]

    Serum samples are planned to be collected at Baseline, Weeks 96 and 144 to assess renal inflammation biomarker - serum creatinine. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus (-) Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

76. Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48 [Baseline (Day 1) and at Weeks 24 and 48]

    EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.

77. Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    EQ-5D-5L questionnaire provides profile of participant function and global health state rating. Five-item measure has 1question assessing each of 5dimensions:mobility,self-care,usual activities,pain/discomfort,anxiety/depression and 5 levels for each dimension including 1=no problems,2=slight problems,3=moderate problems,4=severe problems,5=extreme problems. Health state is defined by combining levels of answers from each of 5 questions. Each health state is referred to in terms of a 5 digit code.Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state.EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.Baseline is latest pre-dose assessment value (Day1) with a non-missing value.Change from Baseline is post-dose visit value - Baseline value.Data is not reported as data collection is still ongoing at time of primary analysis and it will be provided after study completion.

78. Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48 [Baseline (Day 1) and at Weeks 24 and 48]

    EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value.

79. Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144 [Baseline (Day 1) and at Weeks 96 and 144]

    EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participant must be able to understand and comply with protocol requirements, instructions, and restrictions;

• Participant must be likely to complete the study as planned;

• Participant must be considered an appropriate candidate for participation in an investigative clinical trial with medication (example no active substance abuse, acute major organ disease, or planned long-term work assignments out of the country).

• Aged 18 years or older (or older where required by local regulatory agencies), at the time of signing the informed consent.

• HIV-1 infected men or women.

• Documented evidence of at least two plasma HIV-1 RNA measurements <50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening.

• Plasma HIV-1 RNA <50 c/mL at Screening.

• Must be on uninterrupted ART for at least 6 months prior to screening. Only the following regimens are allowed:

• Participant on a TAF-based regimen for at least 6 months as the initial regimen, or

• Participants who switched from a tenofovir disoproxil fumarate (TDF) first-regimen TAF, without any changes to the other drugs in their regimen, and have been on the TAF-based regimen for at least 3 months immediately prior to Screening i.e., the only switch made is from TDF to TAF. This switch must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for suspected or established treatment failure. A switch from a PI boosted with ritonavir to the same PI boosted with cobicistat is allowed (and vice versa).

• A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test at screen and a negative urine hCG test at randomization [a local serum hCG test at Randomization is allowed if it can be done, and results obtained, within 24 hours prior to randomization]), not lactating, and at least one of the following conditions applies:

1. Non-reproductive potential defined as:

• Pre-menopausal females with one of the following:

• Documented tubal ligation

• Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion

• Hysterectomy

• Documented bilateral oophorectomy

• Post-menopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause [refer to laboratory reference ranges for confirmatory levels]). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

1. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and for at least 2 weeks after the last dose of study medication.

• The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. All participants participating in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner.

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and the protocol. Eligible participants or their legal guardians must sign a written informed consent form before any protocol-specified assessments are conducted.

Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.

Exclusion Criteria:

• Women who are breastfeeding or plan to become pregnant or breastfeed during the study.

• Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease, EXCEPT cutaneous Kaposi's sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/millimeter (mm)^3 are NOT exclusionary.

• Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.

• Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).

• Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antigen antibody (anti-HBs) and HBV deoxyribonucleic acid (DNA) as follows: participants positive for HBsAg are excluded; participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.

• Anticipated need for any hepatitis C virus (HCV) therapy during the first 48 weeks of the study, or anticipated need for HCV therapy based on interferon or for any drugs that have a potential for adverse drug-drug interactions with study treatment throughout the entire study period.

• Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.

• History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.

• Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.

• Participants who in the investigator's judgment, poses a significant suicidality risk.

• Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.

• Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; any systemic immune suppressant.

• Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product (IP).

• Use of any regimen consisting of single or dual ART.

• Any evidence of major nucleoside reverse transcriptase inhibitor (NRTI) mutation or presence of any major INSTI resistance-associated mutation in any available prior resistance genotype assay test result, if known, must be provided to ViiV after screening and before randomization for review by ViiV Virology.

• Any verified Grade 4 laboratory abnormality.

• Alanine aminotransferase (ALT) >=5 times (*) the upper limit of normal (ULN) or ALT

=3 * ULN and bilirubin >=1.5 * ULN (with >35 percent [%] direct bilirubin).

• Creatinine clearance of <50 milliliter (mL)/minute/1.73 meter^2 via Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method.

• Within the 6 to 12 month window prior to Screening and after confirmed suppression to <50 c/mL, any plasma HIV-1 RNA measurement >200 c/mL.

• Within the 6 to 12 month window prior to Screening and after confirmed suppression to <50 c/mL, 2 or more plasma HIV-1 RNA measurements >=50 c/mL.

• Within 6 months prior to Screening and after confirmed suppression to <50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement >=50 c/mL.

• Any drug holiday during the 6 months prior to Screening, except for brief periods (less than 1 month) where all ART was stopped due to tolerability and/or safety concerns.

• Any history of switch to another regimen, defined as change of a single drug or multiple drugs simultaneously, due to virologic failure to therapy (defined as a confirmed plasma HIV-1 RNA ≥400 c/mL.

• Participants enrolled in France (or in other countries as required by local regulations or Ethics Committee/Institutional Review Board [IRB]) who:

• Participated in any study using an investigational drug or vaccine during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study, or

• Participate simultaneously in another clinical study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Phoenix	Arizona	United States	85012
2	GSK Investigational Site	Scottsdale	Arizona	United States	85260
3	GSK Investigational Site	Bakersfield	California	United States	93301
4	GSK Investigational Site	Beverly Hills	California	United States	90211
5	GSK Investigational Site	Long Beach	California	United States	90806
6	GSK Investigational Site	Long Beach	California	United States	90813
7	GSK Investigational Site	Los Angeles	California	United States	90027
8	GSK Investigational Site	Los Angeles	California	United States	90036
9	GSK Investigational Site	Los Angeles	California	United States	90069
10	GSK Investigational Site	Oakland	California	United States	94602
11	GSK Investigational Site	Rialto	California	United States	92337
12	GSK Investigational Site	Sacramento	California	United States	95825
13	GSK Investigational Site	San Leandro	California	United States	94577
14	GSK Investigational Site	Torrance	California	United States	90502
15	GSK Investigational Site	Washington	District of Columbia	United States	20005
16	GSK Investigational Site	Washington	District of Columbia	United States	20037
17	GSK Investigational Site	Fort Lauderdale	Florida	United States	33308
18	GSK Investigational Site	Fort Pierce	Florida	United States	34982
19	GSK Investigational Site	Jacksonville	Florida	United States	32209
20	GSK Investigational Site	Miami Beach	Florida	United States	33140
21	GSK Investigational Site	Miami	Florida	United States	33133
22	GSK Investigational Site	Miami	Florida	United States	33136
23	GSK Investigational Site	Orlando	Florida	United States	32803
24	GSK Investigational Site	Sarasota	Florida	United States	34237
25	GSK Investigational Site	Tampa	Florida	United States	33614
26	GSK Investigational Site	West Palm Beach	Florida	United States	33407
27	GSK Investigational Site	Atlanta	Georgia	United States	30309
28	GSK Investigational Site	Decatur	Georgia	United States	30033
29	GSK Investigational Site	Macon	Georgia	United States	31201
30	GSK Investigational Site	Savannah	Georgia	United States	31401
31	GSK Investigational Site	Chicago	Illinois	United States	60613
32	GSK Investigational Site	Indianapolis	Indiana	United States	46202
33	GSK Investigational Site	Springfield	Massachusetts	United States	01105
34	GSK Investigational Site	Berkley	Michigan	United States	48072
35	GSK Investigational Site	Minneapolis	Minnesota	United States	55407
36	GSK Investigational Site	Minneapolis	Minnesota	United States	55415
37	GSK Investigational Site	Kansas City	Missouri	United States	64111
38	GSK Investigational Site	Saint Louis	Missouri	United States	63139
39	GSK Investigational Site	Las Vegas	Nevada	United States	89106
40	GSK Investigational Site	Newark	New Jersey	United States	07102
41	GSK Investigational Site	Bronx	New York	United States	10461
42	GSK Investigational Site	Syracuse	New York	United States	13210
43	GSK Investigational Site	Durham	North Carolina	United States	27710
44	GSK Investigational Site	Huntersville	North Carolina	United States	28078
45	GSK Investigational Site	Philadelphia	Pennsylvania	United States	19107
46	GSK Investigational Site	Memphis	Tennessee	United States	38105-3678
47	GSK Investigational Site	Austin	Texas	United States	78705
48	GSK Investigational Site	Bellaire	Texas	United States	77401
49	GSK Investigational Site	Dallas	Texas	United States	75208
50	GSK Investigational Site	Dallas	Texas	United States	75246
51	GSK Investigational Site	El Paso	Texas	United States	79935
52	GSK Investigational Site	Fort Worth	Texas	United States	76104
53	GSK Investigational Site	Houston	Texas	United States	77098
54	GSK Investigational Site	Lynchburg	Virginia	United States	24501
55	GSK Investigational Site	Darlinghurst, Sydney	New South Wales	Australia	2010
56	GSK Investigational Site	Darlinghurst	New South Wales	Australia	2010
57	GSK Investigational Site	Surry Hills	New South Wales	Australia	2010
58	GSK Investigational Site	Sydney	New South Wales	Australia	2010
59	GSK Investigational Site	Fortitude Valley	Queensland	Australia	4006
60	GSK Investigational Site	Carlton	Victoria	Australia	3053
61	GSK Investigational Site	Clayton	Victoria	Australia	3168
62	GSK Investigational Site	North Fitzroy	Victoria	Australia	3078
63	GSK Investigational Site	Prahran	Victoria	Australia	3181
64	GSK Investigational Site	Antwerpen		Belgium	2000
65	GSK Investigational Site	Brussels		Belgium	1000
66	GSK Investigational Site	Brussels		Belgium	1200
67	GSK Investigational Site	Brussel		Belgium	1090
68	GSK Investigational Site	Gent		Belgium	9000
69	GSK Investigational Site	Winnipeg	Manitoba	Canada	R3A 1R9
70	GSK Investigational Site	Toronto	Ontario	Canada	M5G 2N2
71	GSK Investigational Site	Montreal	Quebec	Canada	H2L 4E9
72	GSK Investigational Site	Montreal	Quebec	Canada	H3A 1T1
73	GSK Investigational Site	Montreal	Quebec	Canada	H4A 3J1
74	GSK Investigational Site	Bordeaux		France	33000
75	GSK Investigational Site	Marseille		France	13003
76	GSK Investigational Site	Nice		France	06202
77	GSK Investigational Site	Paris Cedex 13		France	75651
78	GSK Investigational Site	Paris		France	75012
79	GSK Investigational Site	Paris		France	75018
80	GSK Investigational Site	Tourcoing cedex		France	59208
81	GSK Investigational Site	Muenchen	Bayern	Germany	80335
82	GSK Investigational Site	Muenchen	Bayern	Germany	80336
83	GSK Investigational Site	Muenchen	Bayern	Germany	81675
84	GSK Investigational Site	Frankfurt	Hessen	Germany	60596
85	GSK Investigational Site	Hannover	Niedersachsen	Germany	30625
86	GSK Investigational Site	Koeln	Nordrhein-Westfalen	Germany	50668
87	GSK Investigational Site	Koeln	Nordrhein-Westfalen	Germany	50674
88	GSK Investigational Site	Berlin		Germany	10439
89	GSK Investigational Site	Berlin		Germany	12157
90	GSK Investigational Site	Hamburg		Germany	20146
91	GSK Investigational Site	Hamburg		Germany	20246
92	GSK Investigational Site	München		Germany	80336
93	GSK Investigational Site	Aichi		Japan	460-0001
94	GSK Investigational Site	Chiba		Japan	260-8677
95	GSK Investigational Site	Tokyo		Japan	108-8639
96	GSK Investigational Site	Tokyo		Japan	173-8606
97	GSK Investigational Site	Rotterdam		Netherlands	3015 CE
98	GSK Investigational Site	Vigo	Galicia	Spain	36204
99	GSK Investigational Site	Alcala de Henares		Spain	28805
100	GSK Investigational Site	Alicante		Spain	03010
101	GSK Investigational Site	Badalona		Spain	08916
102	GSK Investigational Site	Barcelona		Spain	08025
103	GSK Investigational Site	Barcelona		Spain	08036
104	GSK Investigational Site	Cartagena (Murcia)		Spain	30202
105	GSK Investigational Site	Elche		Spain	03203
106	GSK Investigational Site	Granada		Spain	18014
107	GSK Investigational Site	Granollers (Barcelona)		Spain	08400
108	GSK Investigational Site	Huelva		Spain	21080
109	GSK Investigational Site	L'Hospitalet de Llobregat		Spain	08907
110	GSK Investigational Site	Madrid		Spain	28034
111	GSK Investigational Site	Madrid		Spain	28040
112	GSK Investigational Site	Madrid		Spain	28041
113	GSK Investigational Site	Madrid		Spain	28046
114	GSK Investigational Site	Majadahonda (Madrid)		Spain	28222
115	GSK Investigational Site	Marbella		Spain	29603
116	GSK Investigational Site	Mataró		Spain	08304
117	GSK Investigational Site	Murcia		Spain	30003
118	GSK Investigational Site	Murcia		Spain	30008
119	GSK Investigational Site	Málaga		Spain	29010
120	GSK Investigational Site	Santiago de Compostela		Spain	15706
121	GSK Investigational Site	Sevilla		Spain	41013
122	GSK Investigational Site	Sevilla		Spain	41041
123	GSK Investigational Site	Valencia		Spain	46010
124	GSK Investigational Site	Valencia		Spain	46026
125	GSK Investigational Site	Vilajoyosa		Spain	3570
126	GSK Investigational Site	Zaragoza		Spain	50009
127	GSK Investigational Site	Birmingham	West Midlands	United Kingdom	B4 6TH
128	GSK Investigational Site	Birmingham		United Kingdom	WS2 9PS
129	GSK Investigational Site	Brighton		United Kingdom	BN2 1ES
130	GSK Investigational Site	Bristol		United Kingdom	BS10 5NB
131	GSK Investigational Site	Crumpsall, Manchester		United Kingdom	M8 5RB
132	GSK Investigational Site	Liverpool		United Kingdom	L7 8XP
133	GSK Investigational Site	London		United Kingdom	WC1E 6LB

Sponsors and Collaborators

• ViiV Healthcare
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

• Study Protocol - Aug 29, 2018
• Statistical Analysis Plan - Dec 19, 2018

More Information

Publications

• van Wyk J, Ajana F, Bisshop F, De Wit S, Osiyemi O, Portilla Sogorb J, Routy JP, Wyen C, Ait-Khaled M, Nascimento MC, Pappa KA, Wang R, Wright J, Tenorio AR, Wynne B, Aboud M, Gartland MJ, Smith KY. Efficacy and Safety of Switching to Dolutegravir/Lamivudine Fixed-Dose 2-Drug Regimen vs Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With Human Immunodeficiency Virus Type 1: Phase 3, Randomized, Noninferiority TANGO Study. Clin Infect Dis. 2020 Nov 5;71(8):1920-1929. doi: 10.1093/cid/ciz1243.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT03446573
• Other Study ID Numbers: 204862; 2015-004401-17
• First Posted: Feb 27, 2018
• Last Update Posted: Jul 14, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ViiV Healthcare: Switch study; Non-inferiority; Human immunodeficiency virus type 1; Tenofovir alafenamide; Dolutegravir; Lamivudine
• Additional relevant MeSH terms: HIV Infections

Study Results

Participant Flow

Recruitment Details	This non-inferiority study evaluated antiviral activity of switching to dolutegravir (DTG) + lamivudine (3TC) fixed dose combination (FDC) once daily compared to continuation of a Tenofovir alafenamide (TAF)-based regimen (TBR) over 48 weeks in virologically suppressed participants with human immunodeficiency type 1 infection.
Pre-assignment Detail	743 participants were enrolled, of which two participants did not receive treatment and hence 741 participants received at least one treatment into the study. The results presented are based on Week 48 primary analysis. Data collection is still on-going and additional results for Weeks 96 and 144 will be provided after study completion.

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Period Title: Overall Study
STARTED	369	372
COMPLETED	0	0
NOT COMPLETED	369	372

Baseline Characteristics

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen	Total
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.	Total of all reporting groups
Overall Participants	369	372	741
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	40.6 (10.76)	40.9 (11.54)	40.8 (11.15)
Sex: Female, Male (Count of Participants)
Female	25 6.8%	33 8.9%	58 7.8%
Male	344 93.2%	339 91.1%	683 92.2%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaska Native	7 1.9%	8 2.2%	15 2%
Asian-Central/South Asian Heritage (H)	3 0.8%	4 1.1%	7 0.9%
Asian-Japanese H/East Asian H/South East Asian H	10 2.7%	9 2.4%	19 2.6%
Black or African American	50 13.6%	58 15.6%	108 14.6%
Native Hawaiian or other Pacific Islander	1 0.3%	3 0.8%	4 0.5%
White-Arabic/North African (NA) H	5 1.4%	2 0.5%	7 0.9%
White-Arabic/NA H and white/caucasia/European H	0 0%	1 0.3%	1 0.1%
White-White/caucasian/European H	292 79.1%	286 76.9%	578 78%
Asian and White	0 0%	1 0.3%	1 0.1%
Black or African American and White	1 0.3%	0 0%	1 0.1%
Cluster of differentiation 4 plus (CD4+) cell count (Cells per cubic millimeter (cells/mm^3)) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Cells per cubic millimeter (cells/mm^3)]	682.0	720.0	688.0
Baseline third agents (Count of Participants)
NNRTI	51 13.8%	48 12.9%	99 13.4%
INSTI	289 78.3%	296 79.6%	585 78.9%
PI	29 7.9%	28 7.5%	57 7.7%
HIV infection by Centers for Disease Control and Prevention (CDC) classification (Count of Participants)
HIV infection Stage 1	255 69.1%	259 69.6%	514 69.4%
HIV infection Stage 2	94 25.5%	94 25.3%	188 25.4%
HIV infection Stage 3	20 5.4%	19 5.1%	39 5.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48
Description	Percentage of participants with virologic failure (plasma HIV-1 RNA >=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who receive at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	372
Number [Percentage of participants]	0.3 0.1%	0.5 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded if the upper bound of a two-sided 95% confidence interval (CI) for the difference in virologic failure rates between the two treatment arms was smaller than 4%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference in proportion (ADP)
	Estimated Value	-0.3
	Confidence Interval	(2-Sided) 95%; -1.2 to 0.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor:Baseline third agent (protease inhibitor [PI], non-nucleoside reverse transcriptase inhibitor [NNRTI], and integrase inhibitor [INI]).

2. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48
Description	Percentage of participants with plasma HIV-1 RNA <50 c/mL (virologic success) was evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
Time Frame	Week 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at specified time points has been analyzed. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	344	346
Number [Percentage of participants]	93.2 25.3%	93.0 25%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority of switching to DTG + 3TC compared to continuation of TBR (as per FDA snapshot algorithm) was to be concluded when the lower bound of a 2-sided 95% confidence interval for the difference in success rates between the two treatment arms was greater than -8%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Adjusted difference in proportion
	Estimated Value	0.2
	Confidence Interval	(2-Sided) 95%; -3.4 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	ADP was based on Cochran-Mantel Haenszel stratified analysis adjusting for Baseline stratification factor: Baseline third agent (PI, NNRTI, and INSTI).

3. Secondary Outcome

Title	Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24
Description	Percentage of participants with plasma HIV-1 RNA >=50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	372
Number [Percentage of participants]	0.3 0.1%	0.8 0.2%

4. Secondary Outcome

Title	Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144
Description	Percentage of participants with plasma HIV-1 RNA >=50 c/mL are planned to be evaluated using FDA snapshot algorithm at Weeks 96 and 144. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24
Description	Percentage of participants with plasma HIV-1 RNA <50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

ITT-E Population. Only those participants with data available at specified time points has been presented. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	350	358
Number [Percentage of participants]	95 25.7%	96 25.8%

6. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144
Description	Percentage of participants with plasma HIV-1 RNA <50 c/mL are planned to be evaluated using FDA snapshot algorithm at Weeks 96 and 144. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
Description	CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. All 741 (369+372) participants were analyzed, however only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	372
Week 24, n=351, 359	21.0	6.0
Week 48, n=344, 345	22.5	11.0

8. Secondary Outcome

Title	Change From Baseline in CD4+ Cell Count at Weeks 96 and 144
Description	CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples are planned to be collected at specified time points to assess CD4+. It is planned to be evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48
Description	Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over 48 Weeks. Baseline (Day 1) values were the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable .
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. All 741 (369+372) participants were analyzed, however only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	372
Baseline (Day 1), n=366, 371	0.950	0.960
Week 24, n=346, 358	0.010	0.040
Week 48, n=342, 343	0.030	0.050

10. Secondary Outcome

Title	Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144
Description	Blood samples are planned to be collected at specified time points to assess CD4+/CD8+ cell count ratio. It is planned to be assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over Weeks 96 and 144. Baseline (Day 1) values are the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Number of Participants With Disease Progression at Weeks 24 and 48
Description	HIV-associated conditions were recorded during the study and was assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV were: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: >=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: with HIV infection and CD4+ T-lymphocye count <200 cells/mcL. Disease progression summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death.
Time Frame	At Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	372
From CDC Stage 1 to CDC Stage 3 Event	1 0.3%	0 0%
From CDC Stage 2 to CDC Stage 3 Event	0 0%	0 0%
From CDC Stage 3 to new CDC Stage 3 Event	0 0%	0 0%
From CDC Stage 1, 2 or 3 to Death	1 0.3%	0 0%
No HIV-1 disease progression	367 99.5%	372 100%

12. Secondary Outcome

Title	Number of Participants With Disease Progression at Weeks 96 and 144
Description	HIV-associated conditions are planned to be recorded during the study and assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV is: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: >=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: with HIV infection and CD4+ T-lymphocye count <200 cells/mcL. Indicators of clinical disease progression is defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	At Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Secondary Outcome

Title	Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48
Description	An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Safety Population included all participants who received at least one dose of study treatment either DTG + 3TC or TBR. This population was based on the treatment the participant actually received. Number of participants with any SAE and common (>=2%) non-SAEs are presented.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Any non-SAE (>=2%)	222 60.2%	204 54.8%
Any SAE	21 5.7%	16 4.3%

14. Secondary Outcome

Title	Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 144
Description	An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Secondary Outcome

Title	Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48
Description	An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Number of TDF-based regimen participants with any SAE and common (>=2%) non-SAEs are presented.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36)
Measure Participants	1
Any non-SAE (>=2%)	1 0.3%
Any SAE	0 0%

16. Secondary Outcome

Title	Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 144
Description	An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

17. Secondary Outcome

Title	Number of Participants With AEs by Their Severity Grades: Up to Week 48
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Grade 1	102 27.6%	94 25.3%
Grade 2	170 46.1%	177 47.6%
Grade 3	19 5.1%	15 4%
Grade 4	3 0.8%	6 1.6%
Grade 5	1 0.3%	0 0%

18. Secondary Outcome

Title	Number of Participants With AEs by Their Severity Grades: Up to Week 144
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events are planned to be evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

19. Secondary Outcome

Title	Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of TDF-based regimen participants with adverse events by maximum grade have been presented.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36)
Measure Participants	1
Grade 1	0 0%
Grade 2	1 0.3%
Grade 3	0 0%
Grade 4	0 0%
Grade 5	0 0%

20. Secondary Outcome

Title	Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 144
Description	An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events are planned to be evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

21. Secondary Outcome

Title	Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Count of Participants [Participants]	13 3.5%	2 0.5%

22. Secondary Outcome

Title	Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

23. Secondary Outcome

Title	Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
Count of Participants [Participants]	0 0%

24. Secondary Outcome

Title	Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 144
Description	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

25. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48
Description	Blood samples were collected up to Week 48 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Hemoglobin, Grade 1	3 0.8%	0 0%
Hemoglobin, Grade 2	0 0%	0 0%
Hemoglobin, Grade 3	0 0%	0 0%
Hemoglobin, Grade 4	0 0%	0 0%
Leukocytes, Grade 1	1 0.3%	1 0.3%
Leukocytes, Grade 2	1 0.3%	0 0%
Leukocytes, Grade 3	0 0%	0 0%
Leukocytes, Grade 4	0 0%	0 0%
Neutrophils, Grade 1	3 0.8%	4 1.1%
Neutrophils, Grade 2	2 0.5%	4 1.1%
Neutrophils, Grade 3	0 0%	0 0%
Neutrophils, Grade 4	1 0.3%	0 0%
Platelets, Grade 1	6 1.6%	5 1.3%
Platelets, Grade 2	1 0.3%	1 0.3%
Platelets, Grade 3	0 0%	0 0%
Platelets, Grade 4	0 0%	0 0%

26. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144
Description	Blood samples are planned to be collected up to Week 144 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters are planned to be evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

27. Secondary Outcome

Title	Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36
Description	Blood samples were collected up to the Week 36 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those TDF-based regimen participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.
Time Frame	Up to Week 36

Outcome Measure Data

Analysis Population Description

Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
Hemoglobin, Grade 1	0 0%
Hemoglobin, Grade 2	0 0%
Hemoglobin, Grade 3	0 0%
Hemoglobin, Grade 4	0 0%
Leukocytes, Grade 1	0 0%
Leukocytes, Grade 2	0 0%
Leukocytes, Grade 3	0 0%
Leukocytes, Grade 4	0 0%
Neutrophils, Grade 1	0 0%
Neutrophils, Grade 2	0 0%
Neutrophils, Grade 3	0 0%
Neutrophils, Grade 4	0 0%
Platelets, Grade 1	0 0%
Platelets, Grade 2	0 0%
Platelets, Grade 3	0 0%
Platelets, Grade 4	0 0%

28. Secondary Outcome

Title	Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144
Description	Blood samples are planned to be collected up to the Week 144 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters are planned to be evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

29. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48
Description	Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
ALT, Grade 1	24 6.5%	18 4.8%
ALT, Grade 2	6 1.6%	4 1.1%
ALT, Grade 3	1 0.3%	1 0.3%
ALT, Grade 4	0 0%	0 0%
Albumin, Grade 1	1 0.3%	0 0%
Albumin, Grade 2	0 0%	0 0%
Albumin, Grade 3	0 0%	0 0%
Albumin, Grade 4	0 0%	0 0%
ALP, Grade 1	2 0.5%	0 0%
ALP, Grade 2	0 0%	0 0%
ALP, Grade 3	0 0%	0 0%
ALP, Grade 4	0 0%	0 0%
AST, Grade 1	21 5.7%	29 7.8%
AST, Grade 2	7 1.9%	4 1.1%
AST, Grade 3	1 0.3%	0 0%
AST, Grade 4	1 0.3%	0 0%
Bilirubin, Grade 1	17 4.6%	7 1.9%
Bilirubin, Grade 2	5 1.4%	2 0.5%
Bilirubin, Grade 3	1 0.3%	1 0.3%
Bilirubin, Grade 4	0 0%	0 0%
CO2, Grade 1	73 19.8%	70 18.8%
CO2, Grade 2	1 0.3%	1 0.3%
CO2, Grade 3	0 0%	0 0%
CO2, Grade 4	0 0%	0 0%
Cholesterol, Grade 1	27 7.3%	52 14%
Cholesterol, Grade 2	12 3.3%	19 5.1%
Cholesterol, Grade 3	1 0.3%	0 0%
Cholesterol, Grade 4	0 0%	0 0%
CK, Grade 1	28 7.6%	19 5.1%
CK, Grade 2	4 1.1%	9 2.4%
CK, Grade 3	9 2.4%	8 2.2%
CK, Grade 4	6 1.6%	5 1.3%
Creatinine, Grade 1	16 4.3%	7 1.9%
Creatinine, Grade 2	3 0.8%	1 0.3%
Creatinine, Grade 3	0 0%	0 0%
Creatinine, Grade 4	0 0%	0 0%
Direct bilirubin, Grade 1	0 0%	0 0%
Direct bilirubin, Grade 2	0 0%	0 0%
Direct bilirubin, Grade 3	8 2.2%	1 0.3%
Direct bilirubin, Grade 4	0 0%	0 0%
GFR from creatinine adjusted using CKD EPI,Grade 1	0 0%	0 0%
GFR from creatinine adjusted using CKD EPI,Grade 2	135 36.6%	83 22.3%
GFR from creatinine adjusted using CKD EPI,Grade 3	26 7%	13 3.5%
GFR from creatinine adjusted using CKD EPI,Grade 4	0 0%	0 0%
GFR from cystatin C adjusted using CKD-EPI,Grade 1	0 0%	0 0%
GFR from cystatin C adjusted using CKD-EPI,Grade 2	52 14.1%	66 17.7%
GFR from cystatin C adjusted using CKD-EPI,Grade 3	5 1.4%	4 1.1%
GFR from cystatin C adjusted using CKD-EPI,Grade 4	1 0.3%	0 0%
Hypercalcemia, Grade 1	7 1.9%	3 0.8%
Hypercalcemia, Grade 2	0 0%	0 0%
Hypercalcemia, Grade 3	0 0%	0 0%
Hypercalcemia, Grade 4	0 0%	0 0%
Hyperglycemia, Grade 1	56 15.2%	64 17.2%
Hyperglycemia, Grade 2	21 5.7%	19 5.1%
Hyperglycemia, Grade 3	2 0.5%	2 0.5%
Hyperglycemia, Grade 4	0 0%	0 0%
Hyperkalemia, Grade 1	0 0%	2 0.5%
Hyperkalemia, Grade 2	2 0.5%	0 0%
Hyperkalemia, Grade 3	0 0%	0 0%
Hyperkalemia, Grade 4	0 0%	0 0%
Hypernatremia, Grade 1	1 0.3%	1 0.3%
Hypernatremia, Grade 2	0 0%	0 0%
Hypernatremia, Grade 3	0 0%	0 0%
Hypernatremia, Grade 4	0 0%	0 0%
Hypocalcemia, Grade 1	8 2.2%	1 0.3%
Hypocalcemia, Grade 2	0 0%	1 0.3%
Hypocalcemia, Grade 3	0 0%	0 0%
Hypocalcemia, Grade 4	0 0%	0 0%
Hypoglycemia, Grade 1	5 1.4%	6 1.6%
Hypoglycemia, Grade 2	3 0.8%	2 0.5%
Hypoglycemia, Grade 3	0 0%	0 0%
Hypoglycemia, Grade 4	0 0%	0 0%
Hypokalemia, Grade 1	7 1.9%	1 0.3%
Hypokalemia, Grade 2	1 0.3%	0 0%
Hypokalemia, Grade 3	0 0%	0 0%
Hypokalemia, Grade 4	0 0%	0 0%
Hyponatremia, Grade 1	8 2.2%	13 3.5%
Hyponatremia, Grade 2	0 0%	2 0.5%
Hyponatremia, Grade 3	0 0%	0 0%
Hyponatremia, Grade 4	0 0%	0 0%
LDL cholesterol, Grade 1	28 7.6%	35 9.4%
LDL cholesterol, Grade 2	13 3.5%	15 4%
LDL cholesterol, Grade 3	6 1.6%	3 0.8%
LDL cholesterol, Grade 4	0 0%	0 0%
Phosphate, Grade 1	38 10.3%	47 12.6%
Phosphate, Grade 2	2 0.5%	7 1.9%
Phosphate, Grade 3	0 0%	0 0%
Phosphate, Grade 4	0 0%	0 0%
Triglycerides, Grade 1	34 9.2%	48 12.9%
Triglycerides, Grade 2	4 1.1%	11 3%
Triglycerides, Grade 3	4 1.1%	4 1.1%
Triglycerides, Grade 4	4 1.1%	0 0%

30. Secondary Outcome

Title	Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144
Description	Blood samples are planned to be collected up to Week 144 for the analysis of clinical chemistry parameters: ALT, albumin, ALP, AST, bilirubin, CO2, cholesterol, CK, creatinine, direct bilirubin, GFR from creatinine adjusted for BSA, GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, LDL cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters are planned to be evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

31. Secondary Outcome

Title	Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36
Description	samples were collected up to the Week 36 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time Frame	Up to Week 36

Outcome Measure Data

Analysis Population Description

Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
ALT, Grade 1	0 0%
ALT, Grade 2	0 0%
ALT, Grade 3	0 0%
ALT, Grade 4	0 0%
Albumin, Grade 1	0 0%
Albumin, Grade 2	0 0%
Albumin, Grade 3	0 0%
Albumin, Grade 4	0 0%
ALP, Grade 1	0 0%
ALP, Grade 2	0 0%
ALP, Grade 3	0 0%
ALP, Grade 4	0 0%
AST, Grade 1	0 0%
AST, Grade 2	0 0%
AST, Grade 3	0 0%
AST, Grade 4	0 0%
Bilirubin, Grade 1	0 0%
Bilirubin, Grade 2	0 0%
Bilirubin, Grade 3	0 0%
Bilirubin, Grade 4	0 0%
CO2, Grade 1	0 0%
CO2, Grade 2	0 0%
CO2, Grade 3	0 0%
CO2, Grade 4	0 0%
Cholesterol, Grade 1	0 0%
Cholesterol, Grade 2	0 0%
Cholesterol, Grade 3	0 0%
Cholesterol, Grade 4	0 0%
CK, Grade 1	0 0%
CK, Grade 2	0 0%
CK, Grade 3	0 0%
CK, Grade 4	0 0%
Creatinine, Grade 1	0 0%
Creatinine, Grade 2	0 0%
Creatinine, Grade 3	0 0%
Creatinine, Grade 4	0 0%
Direct bilirubin, Grade 1	0 0%
Direct bilirubin, Grade 2	0 0%
Direct bilirubin, Grade 3	0 0%
Direct bilirubin, Grade 4	0 0%
GFR from creatinine adjusted using CKD EPI,Grade 1	0 0%
GFR from creatinine adjusted using CKD EPI,Grade 2	0 0%
GFR from creatinine adjusted using CKD EPI,Grade 3	0 0%
GFR from creatinine adjusted using CKD EPI,Grade 4	0 0%
GFR from cystatin C adjusted using CKD-EPI,Grade 1	0 0%
GFR from cystatin C adjusted using CKD-EPI,Grade 2	0 0%
GFR from cystatin C adjusted using CKD-EPI,Grade 3	0 0%
GFR from cystatin C adjusted using CKD-EPI,Grade 4	0 0%
Hypercalcemia, Grade 1	0 0%
Hypercalcemia, Grade 2	0 0%
Hypercalcemia, Grade 3	0 0%
Hypercalcemia, Grade 4	0 0%
Hyperglycemia, Grade 1	0 0%
Hyperglycemia, Grade 2	0 0%
Hyperglycemia, Grade 3	0 0%
Hyperglycemia, Grade 4	0 0%
Hyperkalemia, Grade 1	0 0%
Hyperkalemia, Grade 2	0 0%
Hyperkalemia, Grade 3	0 0%
Hyperkalemia, Grade 4	0 0%
Hypernatremia, Grade 1	0 0%
Hypernatremia, Grade 2	0 0%
Hypernatremia, Grade 3	0 0%
Hypernatremia, Grade 4	0 0%
Hypocalcemia, Grade 1	0 0%
Hypocalcemia, Grade 2	0 0%
Hypocalcemia, Grade 3	0 0%
Hypocalcemia, Grade 4	0 0%
Hypoglycemia, Grade 1	0 0%
Hypoglycemia, Grade 2	0 0%
Hypoglycemia, Grade 3	0 0%
Hypoglycemia, Grade 4	0 0%
Hypokalemia, Grade 1	0 0%
Hypokalemia, Grade 2	0 0%
Hypokalemia, Grade 3	0 0%
Hypokalemia, Grade 4	0 0%
Hyponatremia, Grade 1	0 0%
Hyponatremia, Grade 2	0 0%
Hyponatremia, Grade 3	0 0%
Hyponatremia, Grade 4	0 0%
LDL cholesterol, Grade 1	0 0%
LDL cholesterol, Grade 2	0 0%
LDL cholesterol, Grade 3	0 0%
LDL cholesterol, Grade 4	0 0%
Phosphate, Grade 1	0 0%
Phosphate, Grade 2	0 0%
Phosphate, Grade 3	0 0%
Phosphate, Grade 4	0 0%
Triglycerides, Grade 1	1 0.3%
Triglycerides, Grade 2	0 0%
Triglycerides, Grade 3	0 0%
Triglycerides, Grade 4	0 0%

32. Secondary Outcome

Title	Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144
Description	Blood samples are planned to be collected up to Week 144 for the analysis of clinical chemistry parameters: ALT, albumin, ALP, AST, bilirubin, CO2, cholesterol, CK, creatinine, direct bilirubin, GFR from creatinine adjusted for BSA, GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, LDL cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters are planned to be evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

33. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48
Description	Urine samples were collected at Baseline, Week 24 and Week 48. Baseline is defined as Day 1. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. Change from Baseline in UP/C and UA/C was calculated as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio calculated at Baseline, respectively. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
UA/C, Week 24, n=235, 230	1.080	1.022
UA/C, Week 48, n=230, 224	1.125	1.059
UP/C, Week 24, n=267, 261	0.955	0.976
UP/C, Week 48, n=261, 257	0.971	1.016

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.257
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	1.057
	Confidence Interval	(2-Sided) 95%; 0.960 to 1.164
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 24 has been presented.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.350
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	1.062
	Confidence Interval	(2-Sided) 95%; 0.936 to 1.205
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UA/C at Week 48 has been presented.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.473
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	0.979
	Confidence Interval	(2-Sided) 95%; 0.924 to 1.037
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 24 has been presented.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.212
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	0.956
	Confidence Interval	(2-Sided) 95%; 0.891 to 1.026
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for UP/C at Week 48 has been presented.

34. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144
Description	Urine samples are planned to be collected at Baseline, Weeks 96 and 144. Baseline is defined as Day 1. Change from Baseline in UA/C is defined as UA/C ratio at post-Baseline visit minus UA/C ratio at Baseline. Change from Baseline in UP/C and UA/C is defined as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio at Baseline, respectively. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

35. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen
Description	Urine samples were collected at Baseline, Week 24 and Week 48 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Change from Baseline in UP/C was calculated as UP/C ratio at post-Baseline visit minus UP/C ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
UA/C, Week 24, n=1	0
UP/C, Week 24, n=1	0.3

36. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 in Participants Randomized to TBR Receiving TDF-based Regimen
Description	Urine samples are planned to be collected at Baseline, Weeks 96 and 144 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline in UA/C is defined as UA/C ratio at post-Baseline visit minus UA/C ratio at Baseline. Change from Baseline in UP/C is defined as UP/C ratio at post-Baseline visit minus UP/C ratio at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

37. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48
Description	Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine beta-2 microglobulin/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Week 24, n=136, 141	0.991	1.034
Week 48, n=126, 141	0.973	0.922

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.560
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	0.958
	Confidence Interval	(2-Sided) 95%; 0.830 to 1.106
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 24 has been presented.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.489
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	1.055
	Confidence Interval	(2-Sided) 95%; 0.906 to 1.229
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine beta-2 microglobulin/urine creatinine at Week 48 has been presented.

38. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144
Description	Urine biomarker samples are planned to be collected at Baseline, Weeks 96 and 144 to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine is defined as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

39. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Urine biomarker samples were collected to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Data was not collected for this arm.

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	0

40. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Urine biomarker samples are planned to be collected at Baseline, Weeks 96 and 144 to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine is defined as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

41. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48
Description	Urine biomarker samples were collected at Baseline and at Weeks 24 and 48 to assess urine phosphate. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Week 24, n=348, 352	0.955	0.940
Week 48, n=342, 340	0.969	0.970

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.758
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	1.017
	Confidence Interval	(2-Sided) 95%; 0.915 to 1.130
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 24 has been presented.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.985
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	0.999
	Confidence Interval	(2-Sided) 95%; 0.894 to 1.116
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine phosphate at Week 48 has been presented.

42. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144
Description	Urine biomarker samples are planned to be collected at Baseline, Weeks 96 and 144 to assess urine phosphate. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate is defined as urine phosphate at post-Baseline visit minus urine phosphate at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

43. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Urine biomarker samples were collected to assess urine phosphate. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
Week 24, n=1	2.9

44. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Urine biomarker samples are planned to be collected to assess urine phosphate. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate is defined as urine phosphate at post-Baseline visit minus urine phosphate at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

45. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48
Description	Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine retinol binding protein 4/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio was calculated as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Week 24, n=344, 343	0.860	0.920
Week 48, n=340, 335	1.063	1.068

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.264
	Comments
	Method	Mixed Model Reported Measures
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	0.935
	Confidence Interval	(2-Sided) 95%; 0.830 to 1.052
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 24 has been presented.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.932
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Treatment ratio
	Estimated Value	0.996
	Confidence Interval	(2-Sided) 95%; 0.903 to 1.098
	Parameter Dispersion	Type: Value:
	Estimation Comments	Treatment ratio (DTG+3TC/ TAF based regimen) and 95% CI for Urine retinol binding protein 4/urine creatinine at Week 48 has been presented.

46. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144
Description	Urine biomarker samples are planned to be collected at Baseline, Weeks 96 and 144 to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio is defined as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

47. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Urine biomarker samples were collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine was calculated as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
Week 24, n=1	1.04

48. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Urine biomarker samples are planned to be collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine is defined as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio at Baseline. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

49. Secondary Outcome

Title	Change From Baseline in Fasting Lipids at Weeks 24 and 48
Description	Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma high density lipoprotein (HDL) cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Plasma cholesterol, Week 24, n=282, 264	-0.325	0.000
Plasma cholesterol, Week 48, n=275, 263	-0.200	0.100
Plasma LDL Cholesterol, Week 24, n=282, 264	-0.210	-0.060
Plasma LDL Cholesterol, Week 48, n=275, 263	-0.170	0.070
Plasma Triglycerides, Week 24, n=282, 264	-0.100	0.060
Plasma Triglycerides, Week 48, n=275, 263	-0.100	0.100
Plasma HDL Cholesterol, Week 24, n=282, 264	-0.050	0.050
Plasma HDL Cholesterol, Week 48, n=275, 263	0.000	0.050

50. Secondary Outcome

Title	Change From Baseline in Fasting Lipids at Weeks 96 and 144
Description	Blood samples are planned to be collected at Baseline (Day 1), Weeks 96 and 144 to assess fasting lipids which includes plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value is the value from the latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

51. Secondary Outcome

Title	Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Blood samples were collected at Baseline (Day 1), weeks 24 and 48 visit (participant withdrew from the study at Week 36) to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for fasting lipids in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
Plasma cholesterol, Week 24, n=1	0
Plasma LDL Cholesterol, Week 24, n=1	-0.67
Plasma Triglycerides, Week 24, n=1	1.36
Plasma HDL Cholesterol, Week 24, n=1	0.05

52. Secondary Outcome

Title	Change From Baseline in Fasting Lipids at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Blood samples are planned to be collected to assess fasting lipids which includes plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value is the value from the latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

53. Secondary Outcome

Title	Number of Participants With Genotypic Resistance: Up to Week 48
Description	Plasma samples were collected for drug resistance testing. Number of participants, who met confirmed virologic withdrawal (CVW) criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with emergent genotypic resistance to INSTI, nucleoside reverse transcriptase inhibitor (NRTI), NNRTI and PI was summarized.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

CVW Population comprises all participants in the ITT-E Population who had met the derived CVW criteria. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	0	1
INSTI	0 0%
NRTI	0 0%
NNRTI	0 0%
PI	0 0%

54. Secondary Outcome

Title	Number of Participants With Genotypic Resistance: Up to Week 144
Description	Plasma samples are planned to be collected for drug resistance testing. Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with emergent genotypic resistance to INSTI, NRTI, NNRTI and PI are planned to be summarized. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

55. Secondary Outcome

Title	Number of Participants With Phenotypic Resistance: Up to Week 48
Description	Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented.
Time Frame	Up to Week 48

Outcome Measure Data

Analysis Population Description

CVW Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	0	1
INSTI, DTG, Sensitive	1 0.3%
INSTI, DTG, Resistant	0 0%
INSTI, Bictegravir (BIC), Sensitive	1 0.3%
INSTI, BIC, Resistant	0 0%
INSTI, Elvitegravir (EVG), Sensitive	1 0.3%
INSTI, EVG, Resistant	0 0%
INSTI, Raltegravir (RAL), Sensitive	1 0.3%
INSTI, RAL, Resistant	0 0%
NNRTI, Delavirdine (DLV), Sensitive	1 0.3%
NNRTI, DLV, Resistant	0 0%
NNRTI, Efavirenz (EFV), Sensitive	1 0.3%
NNRTI, EFV, Resistant	0 0%
NNRTI, Etravirine (ETR), Sensitive	1 0.3%
NNRTI, ETR, Resistant	0 0%
NNRTI, Nevirapine (NVP), Sensitive	1 0.3%
NNRTI, NVP, Resistant	0 0%
NNRTI, Rilpivirine (RPV), Sensitive	1 0.3%
NNRTI, RPV, Resistant	0 0%
NRTI, 3TC, Sensitive	1 0.3%
NRTI, 3TC, Resistant	0 0%
NRTI, Abacavir (ABC), Sensitive	1 0.3%
NRTI, ABC, Resistant	0 0%
NRTI, Zidovudine (AZT), Sensitive	1 0.3%
NRTI, AZT, Resistant	0 0%
NRTI, Stavudine (D4T), Sensitive	1 0.3%
NRTI, D4T, Resistant	0 0%
NRTI, Didanosine (DDI), Sensitive	1 0.3%
NRTI, DDI, Resistant	0 0%
NRTI, Emtricitabine (FTC), Sensitive	1 0.3%
NRTI, FTC, Resistant	0 0%
NRTI, Tenofovir (TDF), Sensitive	1 0.3%
NRTI, TDF, Resistant	0 0%
PI, Atazanavir (ATV), Sensitive	1 0.3%
PI, ATV, Resistant	0 0%
PI, Darunavir (DRV), Sensitive	1 0.3%
PI, DRV, Resistant	0 0%
PI, Fosamprenavir (FPV), Sensitive	1 0.3%
PI, FPV, Resistant	0 0%
PI, Indinavir (IDV), Sensitive	1 0.3%
PI, IDV, Resistant	0 0%
PI, Lopinavir (LPV), Sensitive	1 0.3%
PI, LPV, Resistant	0 0%
PI, Nelfinavir (NFV), Sensitive	1 0.3%
PI, NFV, Resistant	0 0%
PI, Ritonavir (RTV), Sensitive	1 0.3%
PI, RTV, Resistant	0 0%
PI, Saquinavir (SQV), Sensitive	1 0.3%
PI, SQV, Resistant	0 0%
PI, Tipranavir (TPV), Sensitive	1 0.3%
PI, TPV, Resistant	0 0%

56. Secondary Outcome

Title	Number of Participants With Phenotypic Resistance: Up to Week 144
Description	Number of participants, who meet CVW criteria (one plasma HIV-1 RNA >=200 c/mL after Day 1 with immediate prior HIV RNA >=50 c/mL), with emergent phenotypic resistance to INSTI and/or NRTI are planned to be summarized. Assessment of antiviral activity of ART using phenotypic test results are planned to be interpreted through a proprietary algorithm (from Monogram Biosciences), which provides the overall susceptibility of the drug. Partially sensitive and resistant calls are considered resistant in this analysis. The phenotypic resistance is planned to be calculated using binary scoring system, where 0 is considered as sensitive and 1 as resistance. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Up to Week 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

57. Secondary Outcome

Title	Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48
Description	Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, body mass index (BMI) (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Bone-ALP, Week 24, n=350, 354	-0.77 (0.112)	-1.05 (0.089)
Bone-ALP, Week 48, n=343, 342	-0.03 (0.145)	-0.34 (0.117)
Osteocalcin, Week 24, n=350 ,353	-1.08 (0.248)	0.26 (0.229)
Osteocalcin, Week 48, n=343, 342	-1.15 (0.260)	0.69 (0.279)
P1NP, Week24, n=349 ,356	7.0 (0.87)	5.0 (0.72)
P1NP, Week48, n=342, 343	9.3 (1.06)	6.4 (1.00)
CTX-1, Week 24,n=350,356	0.0350 (0.01057)	-0.0031 (0.00833)
CTX-1, Week 48, n=343, 343	0.0602 (0.01024)	0.0310 (0.00889)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.047
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.29
	Confidence Interval	(2-Sided) 95%; 0.00 to 0.57
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 24 has been presented

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.094
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 95%; -0.05 to 0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Bone-ALP at Week 48 has been presented

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.34
	Confidence Interval	(2-Sided) 95%; -2.01 to -0.68
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 24 has been presented

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.84
	Confidence Interval	(2-Sided) 95%; -2.59 to -1.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for Osteocalcin at Week 48 has been presented

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.066
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; -0.1 to 4.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 24 has been presented

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.046
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.9
	Confidence Interval	(2-Sided) 95%; 0.0 to 5.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for P1NP at Week 48 has been presented

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.0381
	Confidence Interval	(2-Sided) 95%; 0.0117 to 0.0646
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 24 has been presented

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.032
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.0292
	Confidence Interval	(2-Sided) 95%; 0.0025 to 0.0559
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for CTX-1 at Week 48 has been presented

58. Secondary Outcome

Title	Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144
Description	Serum samples are planned to be collected for analysis of bone biomarkers. Baseline is latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

59. Secondary Outcome

Title	Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48
Description	Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Change from Baseline in bone biomarkers-serum bone-specific ALP (Bone-ALP), osteocalcin, serum P1NP and serum CTX-1 in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
Bone-ALP, Week 24, n=1	0.3
Osteocalcin, Week 24, n=1	13.4
P1NP, Week24, n=1	11
CTX-1, Week 24,n=1	0.045

60. Secondary Outcome

Title	Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 96 and 144
Description	Serum samples are planned to be collected for analysis of bone biomarkers. Baseline is latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

61. Secondary Outcome

Title	Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48
Description	Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value was latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Week 24, n=351, 355	0.0 (1.10)	2.1 (1.15)
Week 48, n=344, 343	-5.8 (1.21)	-3.5 (1.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.173
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.2
	Confidence Interval	(2-Sided) 95%; -5.3 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 24 has been presented

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.168
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.3
	Confidence Interval	(2-Sided) 95%; -5.5 to 1.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum 25 hydroxyvitamin D at Week 48 has been presented

62. Secondary Outcome

Title	Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144
Description	Serum samples are planned to be collected for analysis of 25-hydroxyvitamin D. Baseline value is latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

63. Secondary Outcome

Title	Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Serum samples were collected for the analysis of 25-hydroxyvitamin D. Baseline value was the value from latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum 25-hydroxyvitamin D in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
Week 24, n=1	2

64. Secondary Outcome

Title	Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Serum samples are planned to be collected for the analysis of 25-hydroxyvitamin D. Baseline value is the value from latest pre-dose assessment (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

65. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48
Description	Serum samples were collected to assess renal biomarker. Baseline was latest pre-dose assessment value (Day 1) with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for following:treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Week 24, n=351, 357	-0.03 (0.005)	-0.02 (0.004)
Week 48, n=344, 343	0.00 (0.006)	0.01 (0.005)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95%; -0.03 to 0.00
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 24 has been presented

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.061
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95%; -0.03 to 0.00
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum cystatin C at Week 48 has been presented

66. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144
Description	Serum samples are planned to be collected to assess renal biomarker. Baseline is latest pre-dose assessment value (Day 1) with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

67. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - cystatin C. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum cystatin -C biomarker in TDF based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
Week 24, n=1	0

68. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Serum samples are planned to be collected at Baseline, Weeks 96 and 144 to assess renal inflammation biomarker - cystatin C. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

69. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48
Description	Serum samples were collected to assess serum GFR from cystatin C and from creatinine adjusted using CKD-EPI. Baseline was Day 1 with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
GFR from cystatin C CKD-EPI, Week 24, n=351, 357	3.2 (0.52)	1.5 (0.46)
GFR from cystatin C CKD-EPI, Week 48, n=344, 343	0.1 (0.61)	-1.6 (0.59)
GFR from creatinine CKD-EPI, Week 24, n=351, 359	-8.8 (0.48)	-3.8 (0.47)
GFR from creatinine CKD-EPI, Week 48, n=344, 345	-7.7 (0.48)	-2.9 (0.48)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; 0.4 to 3.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 24 has been presented

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.059
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.6
	Confidence Interval	(2-Sided) 95%; -0.1 to 3.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from cystatin C adjusted using CKD-EPI at Week 48 has been presented

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-5.0
	Confidence Interval	(2-Sided) 95%; -6.3 to -3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 24 has been presented

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.8
	Confidence Interval	(2-Sided) 95%; -6.1 to -3.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TAF based regimen) and its 95% CI for serum GFR from creatinine adjusted using CKD-EPI at Week 48 has been presented

70. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144
Description	Serum samples are planned to be collected to assess serum GFR from cystatin C and from creatinine adjusted using CKD-EPI. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

71. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarkers - serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
GFR from cystatin C CKD-EPI, Week 24, n=1	0
GFR from creatinine CKD-EPI, Week 24, n=1	4

72. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Serum samples are planned to be collected at Baseline, Weeks 96 and 144 to assess renal inflammation biomarkers - serum GFR from cystatin C and from creatinine adjusted using CKD-EPI. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

73. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48
Description	Serum samples were collected to assess renal inflammation biomarker - serum creatinine. Baseline was Day 1 with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	369	371
Week 24, n=351, 359	7.47 (0.466)	3.11 (0.495)
Week 48, n=344, 345	6.67 (0.493)	2.18 (0.450)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.37
	Confidence Interval	(2-Sided) 95%; 3.03 to 5.70
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 24 has been presented.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	4.49
	Confidence Interval	(2-Sided) 95%; 3.18 to 5.81
	Parameter Dispersion	Type: Value:
	Estimation Comments	Mean difference (DTG+3TC - TBR) and its 95% CI for serum creatinine at Week 48 has been presented.

74. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144
Description	Serum samples are planned to be collected to assess renal inflammation biomarker - serum creatinine. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

75. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - serum creatinine. Baseline was defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum creatinine in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Arm/Group Title	Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
Measure Participants	1
Week 24, n=1	-8

76. Secondary Outcome

Title	Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Description	Serum samples are planned to be collected at Baseline, Weeks 96 and 144 to assess renal inflammation biomarker - serum creatinine. Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus (-) Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

77. Secondary Outcome

Title	Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48
Description	EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	364	370
Week 24	0.0029 (0.00383)	0.0046 (0.00352)
Week 48	0.0037 (0.00407)	0.0023 (0.00373)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.741
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.0017
	Confidence Interval	(2-Sided) 95%; -0.0119 to 0.0085
	Parameter Dispersion	Type: Value:
	Estimation Comments	Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.792
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.0015
	Confidence Interval	(2-Sided) 95%; -0.0094 to 0.0123
	Parameter Dispersion	Type: Value:
	Estimation Comments	Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Utility (continuous), Treatment by Visit interaction, and Baseline EQ-5D Utility by Visit interaction, with Visit as the repeated factor.

78. Secondary Outcome

Title	Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144
Description	EQ-5D-5L questionnaire provides profile of participant function and global health state rating. Five-item measure has 1question assessing each of 5dimensions:mobility,self-care,usual activities,pain/discomfort,anxiety/depression and 5 levels for each dimension including 1=no problems,2=slight problems,3=moderate problems,4=severe problems,5=extreme problems. Health state is defined by combining levels of answers from each of 5 questions. Each health state is referred to in terms of a 5 digit code.Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state.EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.Baseline is latest pre-dose assessment value (Day1) with a non-missing value.Change from Baseline is post-dose visit value - Baseline value.Data is not reported as data collection is still ongoing at time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

79. Secondary Outcome

Title	Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48
Description	EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset. Baseline was the latest pre-dose assessment value (Day 1) and change from Baseline=post-dose value minus Baseline value.
Time Frame	Baseline (Day 1) and at Weeks 24 and 48

Outcome Measure Data

Analysis Population Description

ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable. Only those participants with data available at the specified data points were analyzed.

Arm/Group Title	DTG+3TC FDC	TAF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.	Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks. One participant randomized to the this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Measure Participants	364	369
Week 24	1.2 (0.49)	1.3 (0.44)
Week 48	1.1 (0.52)	1.7 (0.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.879
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -1.4 to 1.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Week 24. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DTG+3TC FDC, TAF-based Regimen
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.414
	Comments
	Method	Mixed Model Repeated Measures
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -1.9 to 0.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Week 48. MMRM adjusted for following: Treatment, Visit, Baseline Third Agent Class, Baseline EQ-5D Thermometer (continuous), Treatment by Visit interaction, and Baseline EQ-5D Thermometer by Visit interaction, with Visit as the repeated factor.

80. Secondary Outcome

Title	Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144
Description	EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the latest pre-dose assessment value (Day 1) with a non-missing value. Change from Baseline is defined as post-dose visit value minus Baseline value. Data is not reported as data collection is still ongoing at the time of primary analysis and it will be provided after study completion.
Time Frame	Baseline (Day 1) and at Weeks 96 and 144

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	All-cause mortality, Non-SAEs and SAEs were collected from start of the study treatment (Day 1) up to Week 48
Adverse Event Reporting Description	Safety Population. One participant randomized to TBR received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen." The results presented are based on Week 48 primary analysis. Data collection is still on-going and additional results for Weeks 96 and 144 will be provided after study completion.
Arm/Group Title	DTG + 3TC		TAF Based Regimen		Randomized to TBR But Received TDF-based Regimen
Arm/Group Description	Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) <50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 48 weeks.		Participants who were on a stable TBR and who had an HIV-1 RNA<50 c/mL at the time of screening, were continued to receive TBR up to 48 weeks.		Participant randomized to TBR arm who had HIV-1 RNA <50 c/mL at the time of screening, received TDF-based regimen instead of TAF-based regimen in error. Participant continued to receive TDF-regimen up to the Week 48 visit (participant withdrew from the study at Week 36).
All Cause Mortality
	DTG + 3TC		TAF Based Regimen		Randomized to TBR But Received TDF-based Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/369 (0.3%)		0/371 (0%)		0/1 (0%)
Serious Adverse Events
	DTG + 3TC		TAF Based Regimen		Randomized to TBR But Received TDF-based Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	21/369 (5.7%)		16/371 (4.3%)		0/1 (0%)
Cardiac disorders
Acute myocardial infarction	0/369 (0%)	0	1/371 (0.3%)	2	0/1 (0%)	0
Atrial fibrillation	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Atrial flutter	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Ventricular tachycardia	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Gastrointestinal disorders
Inguinal hernia	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Pancreatitis	0/369 (0%)	0	1/371 (0.3%)	3	0/1 (0%)	0
Hepatobiliary disorders
Cholecystitis	1/369 (0.3%)	1	1/371 (0.3%)	1	0/1 (0%)	0
Biliary dyskinesia	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Cholelithiasis	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Infections and infestations
Pneumonia	2/369 (0.5%)	2	1/371 (0.3%)	1	0/1 (0%)	0
Amniotic cavity infection	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Anal abscess	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Escherichia sepsis	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Labyrinthitis	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Meningitis pneumococcal	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Pertussis	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Pyelonephritis	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Shigella infection	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Injury, poisoning and procedural complications
Femoral neck fracture	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Gun shot wound	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Overdose	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Metabolism and nutrition disorders
Hypokalaemia	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Musculoskeletal and connective tissue disorders
Osteitis	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Diffuse large B-cell lymphoma	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Lung adenocarcinoma	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Metastases to liver	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Penile squamous cell carcinoma	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Nervous system disorders
Cerebral haematoma	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Encephalopathy	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Facial paresis	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Pregnancy, puerperium and perinatal conditions
Amniorrhoea	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Psychiatric disorders
Suicidal ideation	2/369 (0.5%)	2	0/371 (0%)	0	0/1 (0%)	0
Anxiety	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Depression	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Suicide attempt	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Reproductive system and breast disorders
Ovarian cyst	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Ovarian haematoma	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Prostatitis	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Pulmonary embolism	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Vascular disorders
Deep vein thrombosis	1/369 (0.3%)	1	0/371 (0%)	0	0/1 (0%)	0
Vasculitis	0/369 (0%)	0	1/371 (0.3%)	1	0/1 (0%)	0
Other (Not Including Serious) Adverse Events
	DTG + 3TC		TAF Based Regimen		Randomized to TBR But Received TDF-based Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	222/369 (60.2%)		204/371 (55%)		1/1 (100%)
Gastrointestinal disorders
Diarrhoea	30/369 (8.1%)	34	26/371 (7%)	28	1/1 (100%)	1
Nausea	15/369 (4.1%)	16	7/371 (1.9%)	7	0/1 (0%)	0
Abdominal pain	9/369 (2.4%)	12	7/371 (1.9%)	7	0/1 (0%)	0
Toothache	5/369 (1.4%)	5	8/371 (2.2%)	9	0/1 (0%)	0
Vomiting	8/369 (2.2%)	8	4/371 (1.1%)	4	0/1 (0%)	0
Constipation	8/369 (2.2%)	9	2/371 (0.5%)	2	0/1 (0%)	0
General disorders
Fatigue	20/369 (5.4%)	20	3/371 (0.8%)	3	0/1 (0%)	0
Immune system disorders
Seasonal allergy	12/369 (3.3%)	13	3/371 (0.8%)	4	0/1 (0%)	0
Infections and infestations
Nasopharyngitis	43/369 (11.7%)	53	41/371 (11.1%)	51	0/1 (0%)	0
Upper respiratory tract infection	31/369 (8.4%)	42	32/371 (8.6%)	38	1/1 (100%)	1
Syphilis	24/369 (6.5%)	25	13/371 (3.5%)	13	0/1 (0%)	0
Gastroenteritis	13/369 (3.5%)	16	16/371 (4.3%)	16	0/1 (0%)	0
Bronchitis	8/369 (2.2%)	8	20/371 (5.4%)	21	0/1 (0%)	0
Pharyngitis	14/369 (3.8%)	15	11/371 (3%)	12	0/1 (0%)	0
Anal chlamydia infection	8/369 (2.2%)	9	12/371 (3.2%)	16	0/1 (0%)	0
Influenza	9/369 (2.4%)	9	8/371 (2.2%)	8	0/1 (0%)	0
Urinary tract infection	6/369 (1.6%)	8	8/371 (2.2%)	10	0/1 (0%)	0
Urethritis	9/369 (2.4%)	9	4/371 (1.1%)	4	0/1 (0%)	0
Oral herpes	3/369 (0.8%)	3	8/371 (2.2%)	8	0/1 (0%)	0
Proctitis gonococcal	8/369 (2.2%)	9	3/371 (0.8%)	5	0/1 (0%)	0
Metabolism and nutrition disorders
Vitamin D deficiency	12/369 (3.3%)	12	11/371 (3%)	11	0/1 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	21/369 (5.7%)	22	28/371 (7.5%)	31	0/1 (0%)	0
Arthralgia	12/369 (3.3%)	12	13/371 (3.5%)	13	0/1 (0%)	0
Pain in extremity	8/369 (2.2%)	8	4/371 (1.1%)	4	0/1 (0%)	0
Nervous system disorders
Headache	24/369 (6.5%)	37	17/371 (4.6%)	19	0/1 (0%)	0
Dizziness	8/369 (2.2%)	8	8/371 (2.2%)	8	0/1 (0%)	0
Psychiatric disorders
Anxiety	16/369 (4.3%)	16	9/371 (2.4%)	10	0/1 (0%)	0
Depression	9/369 (2.4%)	9	8/371 (2.2%)	8	0/1 (0%)	0
Insomnia	10/369 (2.7%)	10	7/371 (1.9%)	7	0/1 (0%)	0
Reproductive system and breast disorders
Erectile dysfunction	4/369 (1.1%)	4	8/371 (2.2%)	8	0/1 (0%)	0
Respiratory, thoracic and mediastinal disorders
Cough	6/369 (1.6%)	6	9/371 (2.4%)	9	0/1 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.