Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)
Study Details
Study Description
Brief Summary
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DOR/ISL A fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and placebo to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) for 96 weeks. |
Drug: DOR/ISL
100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily
Other Names:
Drug: Placebo to BIC/FTC/TAF
Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily
|
| Active Comparator: BIC/FTC/TAF 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. |
Drug: DOR/ISL
100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily
Other Names:
Drug: BIC/FTC/TAF
50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily
Drug: Placebo to FDC DOR/ISL
Placebo to FDC DOR/ISL in a tablet taken orally, once daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48 [Week 48]
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
- Percentage of Participants With One or More Adverse Events (AEs) up to Week 48 [Up to 48 weeks]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE up to week 48 is presented.
- Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48 [Up to 48 weeks]
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE up to week 48 is presented.
Secondary Outcome Measures
- Participants With HIV-1 RNA ≥50 Copies/mL at Week 96 [Week 96]
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 is presented.
- Participants With HIV-1 RNA ≥50 Copies/mL at Week 144 [Week 144]
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144 is presented.
- Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 [Week 48]
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 is presented using the FDA snapshot missing data approach
- Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48 [Week 48]
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 48 is presented using the FDA snapshot missing data approach.
- Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 96 [Week 96]
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 96 is presented.
- Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 144 [Week 144]
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 144 is presented.
- Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48 [Baseline and Week 48]
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 48 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
- Change From Baseline in CD4+ T-cell Count at Week 96 [Baseline and Week 96]
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 96 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
- Change From Baseline in CD4+ T-cell Count at Week 144 [Baseline and Week 144]
Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 144 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
- Participants With Viral Drug Resistance-associated Substitutions at Week 48 [Week 48]
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL having genotypic or phenotypic evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
- Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96 [Week 96]
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
- Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 144 [Week 144]
Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
- Change From Baseline in Body Weight at Week 48 [Baseline and Week 48]
Body weight was measured and recorded at baseline and week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 48 is presented.
- Change From Baseline in Body Weight at Week 96 [Baseline and Week 96]
Body weight was measured and recorded at baseline and week 96. Participants removed their shoes and wore a single layer of clothing at each measurement.
- Change From Baseline in Body Weight at Week 144 [Baseline and Week 144]
Body weight was measured and recorded at baseline and week 144. Participants removed their shoes and wore a single layer of clothing at each measurement.
- Percentage of Participants With One or More 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 study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
- Percentage of Participants Who Discontinued Study Intervention Due to an AE 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 study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA <50 copies/mL at screening.
-
Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA <50 copies/mL) for ≥3 months prior to signing informed consent and has no history of prior virologic treatment failure on any past or current regimen.
-
Female is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 24 hours before the first dose of study intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
Exclusion Criteria:
-
Has HIV-2 infection.
-
Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B Virus (HBV) co-infection.
-
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi's sarcoma.
-
Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies.
-
Is currently participating in or has participated in a clinical study with an investigational compound or device from 45 days prior to Day 1 through the study treatment period.
-
Has a documented or known virologic resistance to DOR.
-
Female expects to conceive or donate eggs at any time during the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pueblo Family Physicians ( Site 2717) | Phoenix | Arizona | United States | 85015 |
| 2 | Pacific Oaks Medical Group ( Site 2765) | Beverly Hills | California | United States | 90211 |
| 3 | Men's Health Foundation ( Site 2749) | Los Angeles | California | United States | 80069 |
| 4 | Kaiser Permanente Los Angeles Medical Center ( Site 2775) | Los Angeles | California | United States | 90027 |
| 5 | Eisenhower Medical Center ( Site 2744) | Palm Springs | California | United States | 92264 |
| 6 | University of California, Davis, Division of ID Research ( Site 2702) | Sacramento | California | United States | 95811 |
| 7 | Zuckerberg San Francisco General Hospital UCSF ( Site 2743) | San Francisco | California | United States | 94110 |
| 8 | Whitman-Walker Clinic ( Site 2728) | Washington | District of Columbia | United States | 20009 |
| 9 | TheraFirst Medical Center ( Site 2742) | Fort Lauderdale | Florida | United States | 33308 |
| 10 | Midway Immunology and Research ( Site 2759) | Fort Pierce | Florida | United States | 34982 |
| 11 | AHF South Beach ( Site 2780) | Miami Beach | Florida | United States | 33140 |
| 12 | The Kinder Medical Group ( Site 2739) | Miami | Florida | United States | 33133 |
| 13 | Orlando Immunology Center ( Site 2734) | Orlando | Florida | United States | 32803 |
| 14 | Triple O Research Institute, P.A. ( Site 2755) | West Palm Beach | Florida | United States | 33407 |
| 15 | Augusta University ( Site 2752) | Augusta | Georgia | United States | 30912 |
| 16 | Infectious Disease Specialists Of Atlanta PC ( Site 2719) | Decatur | Georgia | United States | 30033 |
| 17 | Mercer University ( Site 2738) | Macon | Georgia | United States | 31201 |
| 18 | Chatham County Health Department ( Site 2731) | Savannah | Georgia | United States | 31401 |
| 19 | Hennepin County Medical Center ( Site 2733) | Minneapolis | Minnesota | United States | 55415 |
| 20 | Kansas City CARE Clinic ( Site 2718) | Kansas City | Missouri | United States | 64111 |
| 21 | ID Care ( Site 2751) | Hillsborough | New Jersey | United States | 08844 |
| 22 | Montefiore Einstein Center ( Site 2730) | Bronx | New York | United States | 10467 |
| 23 | Icahn School of Medicine at Mount Sinai ( Site 2700) | New York | New York | United States | 10029 |
| 24 | North Texas ID Consultants, PA ( Site 2707) | Dallas | Texas | United States | 75246 |
| 25 | The Crofoot Research Center, Inc. ( Site 2715) | Houston | Texas | United States | 77098 |
| 26 | DCOL Center for Clinical Research ( Site 2769) | Longview | Texas | United States | 75605 |
| 27 | Dr. Peter Shalit, MD ( Site 2770) | Seattle | Washington | United States | 98104 |
| 28 | Multicare Health System ( Site 2713) | Spokane | Washington | United States | 99204 |
| 29 | St Vincent's Hospital ( Site 3807) | Darlinghurst | New South Wales | Australia | 2010 |
| 30 | Taylor Square Private Clinic ( Site 3804) | Darlinghurst | New South Wales | Australia | 2010 |
| 31 | Holdsworth House Medical Practice ( Site 3800) | Sydney | New South Wales | Australia | 2010 |
| 32 | Holdsworth House Medical Practice - Brisbane ( Site 3810) | Brisbane | Queensland | Australia | 4006 |
| 33 | Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812) | Herston | Queensland | Australia | 4029 |
| 34 | The Alfred Hospital ( Site 3802) | Melbourne | Victoria | Australia | 3004 |
| 35 | Prahran Market Clinic (PMC) ( Site 3806) | Melbourne | Victoria | Australia | 3181 |
| 36 | LKH Graz West ( Site 3401) | Graz | Steiermark | Austria | 8020 |
| 37 | Medical University Vienna ( Site 3402) | Vienna | Wien | Austria | 1090 |
| 38 | Sozialmedizinisches Zentrum Sued - Kaiser-Franz-Josef-Spital ( Site 3400) | Vienna | Wien | Austria | 1100 |
| 39 | Social Medical Center - Otto Wagner Hospital ( Site 3404) | Vienna | Wien | Austria | 1145 |
| 40 | Vancouver ID Research and Care Centre Society ( Site 2800) | Vancouver | British Columbia | Canada | V6Z 2C7 |
| 41 | Hamilton Health Sciences ( Site 2803) | Hamilton | Ontario | Canada | L8L 2X2 |
| 42 | Clinique de Medecine Urbaine du Quartier Latin ( Site 2804) | Montreal | Quebec | Canada | H2L 4E9 |
| 43 | Clinique Medicale L Actuel ( Site 2814) | Montreal | Quebec | Canada | H2L 4P9 |
| 44 | Helsinki University Hospital ( Site 3200) | Helsinki | Uusimaa | Finland | 00029 |
| 45 | Hopital Edouard Herriot ( Site 3126) | Lyon | Ain | France | 69003 |
| 46 | CHU de Nice Hopital Archet 1 ( Site 3103) | Nice | Alpes-Maritimes | France | 06202 |
| 47 | Hopital Europeen Marseille ( Site 3117) | Marseille | Bouches-du-Rhone | France | 13003 |
| 48 | Hopital Foch ( Site 3129) | Suresnes | Hauts-de-Seine | France | 92151 |
| 49 | CHU de Montpellier - Hopital Saint-Eloi ( Site 3121) | Montpellier | Herault | France | 34295 |
| 50 | CHU Hotel Dieu Nantes ( Site 3120) | Nantes | Loire-Atlantique | France | 44093 |
| 51 | Centre Hospitalier Regional du Orleans ( Site 3108) | Orleans | Loiret | France | 45000 |
| 52 | CHU de Nancy Hopital Brabois Adultes ( Site 3128) | Vandoeuvre les Nancy | Meurthe-et-Moselle | France | 54511 |
| 53 | Centre Hospitalier de Tourcoing ( Site 3100) | Tourcoing | Nord | France | 59208 |
| 54 | Hopital Saint-Antoine ( Site 3113) | Paris | France | 75012 | |
| 55 | Hopital Pitie Salpetriere ( Site 3111) | Paris | France | 75013 | |
| 56 | Hopital Tenon ( Site 3118) | Paris | France | 75020 | |
| 57 | MVZ Karlsplatz Dr.med.Hans Jaeger ( Site 3002) | Muenchen | Bayern | Germany | 80335 |
| 58 | Klinikum der LMU München ( Site 3004) | Muenchen | Bayern | Germany | 80336 |
| 59 | Klinikum rechts der Isar der Technischen Universitat ( Site 3005) | Muenchen | Bayern | Germany | 81675 |
| 60 | Infektiologikum ( Site 3001) | Frankfurt am Main | Hessen | Germany | 60596 |
| 61 | Medizinische Hochschule Hannover ( Site 3012) | Hannover | Niedersachsen | Germany | 30625 |
| 62 | Universitaetsklinikum Bonn ( Site 3000) | Bonn | Nordrhein-Westfalen | Germany | 53127 |
| 63 | Universitaetsklinikum Essen ( Site 3007) | Essen | Nordrhein-Westfalen | Germany | 45122 |
| 64 | ZIBP-Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH ( Site 3003) | Berlin | Germany | 10439 | |
| 65 | EPIMED GmbH ( Site 3008) | Berlin | Germany | 12167 | |
| 66 | ICH Study Center GmbH & Co.KG ( Site 3009) | Hamburg | Germany | 20146 | |
| 67 | Universitaetsklinikum Hamburg- Eppendorf (UKE) ( Site 3010) | Hamburg | Germany | 20246 | |
| 68 | Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico ( Site 3501) | Milano | Lombardia | Italy | 20122 |
| 69 | Universita' Vita Salute. Ospedale San Raffaele ( Site 3502) | Milano | Italy | 20127 | |
| 70 | Azienda Ospedaliera San Paolo ( Site 3503) | Milano | Italy | 20142 | |
| 71 | ASST Fatebenefratelli-Ospedale Sacco ( Site 3500) | Milano | Italy | 20157 | |
| 72 | A.O.R.N. dei Colli - Ospedale Cotugno ( Site 3507) | Napoli | Italy | 80131 | |
| 73 | National Hospital Organization Nagoya Medical Center ( Site 7203) | Nagoya | Aichi | Japan | 460-0001 |
| 74 | National Hospital Organization Osaka National Hospital ( Site 7202) | Osaka | Japan | 540-0006 | |
| 75 | Center Hospital of the National Center for Global Health and Medicine ( Site 7201) | Tokyo | Japan | 162-8655 | |
| 76 | CAIMED Center - Ponce School of Medicine ( Site 2903) | Ponce | Puerto Rico | 00716 | |
| 77 | Puerto Rico CONCRA ( Site 2904) | Rio Piedras | Puerto Rico | 00925 | |
| 78 | Clinical Research Puerto Rico Inc ( Site 2900) | San Juan | Puerto Rico | 00909 | |
| 79 | Hope Clinical Research, Inc. ( Site 2902) | San Juan | Puerto Rico | 00909 | |
| 80 | Hospital Universitari Germans Trias i Pujol ( Site 3601) | Badalona | Barcelona [Barcelona] | Spain | 08916 |
| 81 | Hospital Universitari Vall d Hebron ( Site 3602) | Barcelona | Barcelona [Barcelona] | Spain | 08035 |
| 82 | Hospital Universitari de Bellvitge ( Site 3612) | LHospitalet de Llobregat | Barcelona [Barcelona] | Spain | 08907 |
| 83 | Hospital Clinic i Provincial ( Site 3600) | Barcelona | Spain | 08036 | |
| 84 | Hospital General Universitario Gregorio Maranon ( Site 3603) | Madrid | Spain | 28007 | |
| 85 | Hospital Universitario Infanta Leonor ( Site 3606) | Madrid | Spain | 28031 | |
| 86 | Hospital Universitario Ramon y Cajal ( Site 3611) | Madrid | Spain | 28034 | |
| 87 | Hospital 12 de Octubre de Madrid ( Site 3605) | Madrid | Spain | 28041 | |
| 88 | Hospital Universitario La Paz ( Site 3604) | Madrid | Spain | 28046 | |
| 89 | Hospital Universitario Virgen de la Victoria ( Site 3609) | Malaga | Spain | 29010 |
Sponsors and Collaborators
- Merck Sharp & Dohme LLC
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Study Documents (Full-Text)
More Information
Publications
None provided.- 8591A-018
- MK-8591A-018
- 205166
- 2019-000587-23
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | DOR/ISL | BIC/FTC/TAF |
|---|---|---|
| Arm/Group Description | A fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and placebo to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) for 96 weeks. | 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. |
| Period Title: Overall Study | ||
| STARTED | 322 | 321 |
| Treated | 322 | 319 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 322 | 321 |
Baseline Characteristics
| Arm/Group Title | DOR/ISL | BIC/FTC/TAF | Total |
|---|---|---|---|
| Arm/Group Description | An FDC of 100 mg DOR/0.75 mg ISL for 144 weeks; and placebo to BIC/FTC/TAF for 96 weeks. | 50 mg BIC, 200 mg FTC, 25 mg TAF for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. | Total of all reporting groups |
| Overall Participants | 322 | 321 | 643 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
47.6
(12.6)
|
48.0
(11.8)
|
47.8
(12.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
105
32.6%
|
78
24.3%
|
183
28.5%
|
| Male |
217
67.4%
|
243
75.7%
|
460
71.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
64
19.9%
|
55
17.1%
|
119
18.5%
|
| Not Hispanic or Latino |
256
79.5%
|
261
81.3%
|
517
80.4%
|
| Unknown or Not Reported |
2
0.6%
|
5
1.6%
|
7
1.1%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
3
0.9%
|
2
0.6%
|
5
0.8%
|
| Asian |
14
4.3%
|
13
4%
|
27
4.2%
|
| Native Hawaiian or Other Pacific Islander |
2
0.6%
|
0
0%
|
2
0.3%
|
| Black or African American |
58
18%
|
56
17.4%
|
114
17.7%
|
| White |
240
74.5%
|
240
74.8%
|
480
74.7%
|
| More than one race |
5
1.6%
|
7
2.2%
|
12
1.9%
|
| Unknown or Not Reported |
0
0%
|
3
0.9%
|
3
0.5%
|
Outcome Measures
| Title | Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) ≥50 Copies/mL at Week 48 |
|---|---|
| Description | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach. |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized. |
| Arm/Group Title | DOR/ISL | BIC/FTC/TAF |
|---|---|---|
| Arm/Group Description | An FDC of 100 mg DOR/0.75 mg ISL for 144 weeks; and placebo to BIC/FTC/TAF for 96 weeks. | 50 mg BIC, 200 mg FTC, 25 mg TAF for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. |
| Measure Participants | 322 | 319 |
| Number [Percentage of Participants] |
0.6
0.2%
|
0.3
0.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DOR/ISL, BIC/FTC/TAF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority | |
| Comments | Non-inferiority is concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI for the difference in the percentage of participants with HIV-1 RNA ≥50 copies/mL (DOR/ISL-BIC/FTC/TAF) is less than 4 percentage points. | |
| Statistical Test of Hypothesis | p-Value | <.001 |
| Comments | p-value for the treatment differences in percent response were calculated using the unstratified Miettinen and Nurminen method. | |
| Method | Unstratified Miettinen and Nurminen | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Estimated difference |
| Estimated Value | 0.31 | |
| Confidence Interval |
(2-Sided) 95% -1.19 to 1.96 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment difference for DOR/ISL group-BIC/FTC/TAF group. | |
| Title | Percentage of Participants With One or More Adverse Events (AEs) up to Week 48 |
|---|---|
| Description | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE up to week 48 is presented. |
| Time Frame | Up to 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received. |
| Arm/Group Title | DOR/ISL | BIC/FTC/TAF |
|---|---|---|
| Arm/Group Description | An FDC of 100 mg DOR/0.75 mg ISL for 144 weeks; and placebo to BIC/FTC/TAF for 96 weeks. | 50 mg BIC, 200 mg FTC, 25 mg TAF for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. |
| Measure Participants | 322 | 319 |
| Number [Percentage of Participants] |
71.1
22.1%
|
74.6
23.2%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DOR/ISL, BIC/FTC/TAF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Difference between treatment groups | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in % (DOR/ISL- BIC/FTC/TAF) |
| Estimated Value | -3.5 | |
| Confidence Interval |
(2-Sided) 95% -10.4 to 3.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Based on Miettinen and Nurminen method | |
| Title | Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48 |
|---|---|
| Description | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE up to week 48 is presented. |
| Time Frame | Up to 48 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received ≥1 dose of study intervention. Participants were included in the treatment group corresponding to the study intervention received. |
| Arm/Group Title | DOR/ISL | BIC/FTC/TAF |
|---|---|---|
| Arm/Group Description | An FDC of 100 mg DOR/0.75 mg ISL for 144 weeks; and placebo to BIC/FTC/TAF for 96 weeks. | 50 mg BIC, 200 mg FTC, 25 mg TAF for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. |
| Measure Participants | 322 | 319 |
| Number [Percentage of Participants] |
2.5
0.8%
|
2.5
0.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DOR/ISL, BIC/FTC/TAF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Other | |
| Comments | Difference between treatment groups | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in % (DOR/ISL- BIC/FTC/TAF) |
| Estimated Value | -0.02 | |
| Confidence Interval |
(2-Sided) 95% -2.7 to 2.6 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Based on Miettinen and Nurminen method | |
| Title | Participants With HIV-1 RNA ≥50 Copies/mL at Week 96 |
|---|---|
| Description | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 is presented. |
| Time Frame | Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Participants With HIV-1 RNA ≥50 Copies/mL at Week 144 |
|---|---|
| Description | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144 is presented. |
| Time Frame | Week 144 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 |
|---|---|
| Description | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 is presented using the FDA snapshot missing data approach |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized. |
| Arm/Group Title | DOR/ISL | BIC/FTC/TAF |
|---|---|---|
| Arm/Group Description | An FDC of 100 mg DOR/0.75 mg ISL for 144 weeks; and placebo to BIC/FTC/TAF for 96 weeks. | 50 mg BIC, 200 mg FTC, 25 mg TAF for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. |
| Measure Participants | 322 | 319 |
| Number [Percentage of Participants] |
93.8
29.1%
|
94.4
29.4%
|
| Title | Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48 |
|---|---|
| Description | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 48 is presented using the FDA snapshot missing data approach. |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received ≥1 dose of study intervention. Participants were included in the treatment group to which they were randomized. |
| Arm/Group Title | DOR/ISL | BIC/FTC/TAF |
|---|---|---|
| Arm/Group Description | An FDC of 100 mg DOR/0.75 mg ISL for 144 weeks; and placebo to BIC/FTC/TAF for 96 weeks. | 50 mg BIC, 200 mg FTC, 25 mg TAF for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. |
| Measure Participants | 322 | 319 |
| Number [Percentage of Participants] |
93.2
28.9%
|
94.0
29.3%
|
| Title | Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 96 |
|---|---|
| Description | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 96 is presented. |
| Time Frame | Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 144 |
|---|---|
| Description | The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 144 is presented. |
| Time Frame | Week 144 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48 |
|---|---|
| Description | Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 48 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline. |
| Time Frame | Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who received ≥1 dose of study intervention and who had baseline data for CD4+ T-cell count. Participants were included in the treatment group to which they were randomized. |
| Arm/Group Title | DOR/ISL | BIC/FTC/TAF |
|---|---|---|
| Arm/Group Description | An FDC of 100 mg DOR/0.75 mg ISL for 144 weeks; and placebo to BIC/FTC/TAF for 96 weeks. | 50 mg BIC, 200 mg FTC, 25 mg TAF for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. |
| Measure Participants | 301 | 298 |
| Mean (95% Confidence Interval) [cells/mm^3] |
-19.66
|
40.51
|
| Title | Change From Baseline in CD4+ T-cell Count at Week 96 |
|---|---|
| Description | Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 96 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline. |
| Time Frame | Baseline and Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change From Baseline in CD4+ T-cell Count at Week 144 |
|---|---|
| Description | Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 144 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline. |
| Time Frame | Baseline and Week 144 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Participants With Viral Drug Resistance-associated Substitutions at Week 48 |
|---|---|
| Description | Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL having genotypic or phenotypic evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented. |
| Time Frame | Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who met the definition of confirmed virologic rebound (two consecutive [2 to 4 weeks apart] occurrences of HIV-1 RNA ≥200 copies/mL) at any time during the study or who discontinued study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included. |
| Arm/Group Title | DOR/ISL | BIC/FTC/TAF |
|---|---|---|
| Arm/Group Description | An FDC of 100 mg DOR/0.75 mg ISL for 144 weeks; and placebo to BIC/FTC/TAF for 96 weeks. | 50 mg BIC, 200 mg FTC, 25 mg TAF for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. |
| Measure Participants | 1 | 0 |
| Count of Participants [Participants] |
0
0%
|
| Title | Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96 |
|---|---|
| Description | Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented. |
| Time Frame | Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 144 |
|---|---|
| Description | Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented. |
| Time Frame | Week 144 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change From Baseline in Body Weight at Week 48 |
|---|---|
| Description | Body weight was measured and recorded at baseline and week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 48 is presented. |
| Time Frame | Baseline and Week 48 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who received ≥1 dose of study intervention and were included in the treatment group corresponding to the study intervention received. The analysis population included participants with baseline and at least one postbaseline test result in the specified analysis window. |
| Arm/Group Title | DOR/ISL | BIC/FTC/TAF |
|---|---|---|
| Arm/Group Description | An FDC of 100 mg DOR/0.75 mg ISL for 144 weeks; and placebo to BIC/FTC/TAF for 96 weeks. | 50 mg BIC, 200 mg FTC, 25 mg TAF for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. |
| Measure Participants | 306 | 302 |
| Mean (Standard Deviation) [kilogram (kg)] |
0.23
(4.19)
|
0.55
(4.40)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | DOR/ISL, BIC/FTC/TAF |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.392 |
| Comments | ||
| Method | ANCOVA | |
| Comments | Model included terms for baseline weight, sex, race, and treatment. | |
| Method of Estimation | Estimation Parameter | Treatment Difference |
| Estimated Value | -0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.99 to 0.39 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Treatment difference for DOR/ISL group-BIC/FTC/TAF group. | |
| Title | Change From Baseline in Body Weight at Week 96 |
|---|---|
| Description | Body weight was measured and recorded at baseline and week 96. Participants removed their shoes and wore a single layer of clothing at each measurement. |
| Time Frame | Baseline and Week 96 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Change From Baseline in Body Weight at Week 144 |
|---|---|
| Description | Body weight was measured and recorded at baseline and week 144. Participants removed their shoes and wore a single layer of clothing at each measurement. |
| Time Frame | Baseline and Week 144 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Percentage of Participants With One or More AEs up to Week 144 |
|---|---|
| Description | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
| Time Frame | Up to Week 144 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 144 |
|---|---|
| Description | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
| Time Frame | Up to Week 144 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Up to 48 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | All-cause mortality population includes all randomized participants in their planned treatment groups. Adverse event population includes all randomized participants who received ≥1 dose of study intervention and were included in the treatment group corresponding to the study intervention received. | |||
| Arm/Group Title | DOR/ISL | BIC/FTC/TAF | ||
| Arm/Group Description | An FDC of 100 mg DOR/0.75 mg ISL for 144 weeks; and placebo to BIC/FTC/TAF for 96 weeks. | 50 mg BIC, 200 mg FTC, 25 mg TAF for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156. | ||
All Cause Mortality |
||||
| DOR/ISL | BIC/FTC/TAF | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/322 (0.3%) | 0/321 (0%) | ||
Serious Adverse Events |
||||
| DOR/ISL | BIC/FTC/TAF | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/322 (4%) | 15/319 (4.7%) | ||
| Cardiac disorders | ||||
| Acute myocardial infarction | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Aortic valve incompetence | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Mitral valve incompetence | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Myocardial ischaemia | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Gastrointestinal disorders | ||||
| Colitis | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Splenic artery aneurysm | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| General disorders | ||||
| Non-cardiac chest pain | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Cholecystitis acute | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Cholelithiasis | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Infections and infestations | ||||
| Atypical pneumonia | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| COVID-19 | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| COVID-19 pneumonia | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Clostridium difficile colitis | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Cystitis | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Cystitis escherichia | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Endocarditis bacterial | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Neurosyphilis | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Pyelonephritis | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Sepsis | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Skull fracture | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Metabolism and nutrition disorders | ||||
| Type 2 diabetes mellitus | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Breast cancer metastatic | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Malignant melanoma | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Nervous system disorders | ||||
| Brachial plexopathy | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Cerebrovascular accident | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Ischaemic stroke | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Status epilepticus | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Psychiatric disorders | ||||
| Bipolar disorder | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Drug abuse | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Renal and urinary disorders | ||||
| Renal colic | 0/322 (0%) | 0 | 1/319 (0.3%) | 1 |
| Reproductive system and breast disorders | ||||
| Cervical dysplasia | 1/322 (0.3%) | 1 | 0/319 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Asthma | 1/322 (0.3%) | 2 | 1/319 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| DOR/ISL | BIC/FTC/TAF | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 71/322 (22%) | 80/319 (25.1%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 8/322 (2.5%) | 8 | 20/319 (6.3%) | 21 |
| Infections and infestations | ||||
| COVID-19 | 18/322 (5.6%) | 18 | 18/319 (5.6%) | 19 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 17/322 (5.3%) | 22 | 19/319 (6%) | 21 |
| Back pain | 13/322 (4%) | 14 | 17/319 (5.3%) | 17 |
| Nervous system disorders | ||||
| Headache | 25/322 (7.8%) | 42 | 23/319 (7.2%) | 23 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Results Point of Contact
| Name/Title | Senior Vice President, Global Clinical Development |
|---|---|
| Organization | Merck Sharp & Dohme LLC |
| Phone | 1-800-672-6372 |
| ClinicalTrialsDisclosure@merck.com |
- 8591A-018
- MK-8591A-018
- 205166
- 2019-000587-23