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Study to Evaluate the Safety and Efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in Human Immunodeficiency Virus (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02607956
Collaborator
(none)
657
Enrollment
125
Locations
4
Arms
67.8
Actual Duration (Months)
5.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This primary objective of this study is to evaluate the efficacy of a fixed dose combination (FDC) containing bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + a FDC containing emtricitabine/tenofovir alafenamide (F/TAF) in HIV-1 infected, antiretroviral treatment-naive adults.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
657 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Actual Study Start Date :
Nov 11, 2015
Actual Primary Completion Date :
May 12, 2017
Actual Study Completion Date :
Jul 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: B/F/TAF

B/F/TAF + DTG + F/TAF placebo administered without regard to food for at least 144 weeks.

Drug: B/F/TAF
50/200/25 milligrams (mg) FDC tablets administered orally, once daily
Other Names:
  • GS-9883/F/TAF
  • Biktarvy®

    • Drug: DTG Placebo
    Tablets administered orally, once daily

    Drug: F/TAF Placebo
    Tablets administered orally, once daily
    Active Comparator: DTG + F/TAF

    DTG + F/TAF+ B/F/TAF placebo administered without regard to food for at least 144 weeks.

    Drug: DTG
    50 mg tablets administered orally, once daily
    Other Names:
  • Tivicay®

    • Drug: F/TAF
    200/25 mg tablets administered orally, once daily
    Other Names:
  • Descovy®

    • Drug: B/F/TAF Placebo
    Tablets administered orally, once daily
    Experimental: Open-label Phase B/F/TAF from B/F/TAF

    After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

    Drug: B/F/TAF
    50/200/25 milligrams (mg) FDC tablets administered orally, once daily
    Other Names:
  • GS-9883/F/TAF
  • Biktarvy®

    		•
    Experimental: Open-label Phase B/F/TAF from DTG + F/TAF

    After Week 144, participants will continue to take their blinded study drug and attend visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants will be given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF is not commercially available will be given the option to continue OL B/F/TAF until the product becomes accessible through an access program or until Gilead elects to discontinue the study in that country, whichever occurs first.

    Drug: B/F/TAF
    50/200/25 milligrams (mg) FDC tablets administered orally, once daily
    Other Names:
  • GS-9883/F/TAF
  • Biktarvy®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [Week 48]

      The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    Secondary Outcome Measures

    1. Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [Week 96]

      The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    2. Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm [Week 144]

      The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    3. Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [Week 48]

      The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    4. Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm [Week 96]

      The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    5. Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm [Week 144]

      The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.

    6. Change From Baseline in log10 HIV-1 RNA at Week 48 [Baseline, Week 48]

    7. Change From Baseline in log10 HIV-1 RNA at Week 96 [Baseline, Week 96]

    8. Change From Baseline in log10 HIV-1 RNA at Week 144 [Baseline, Week 144]

    9. Change From Baseline in CD4+ Cell Count at Week 48 [Baseline, Week 48]

    10. Change From Baseline in CD4+ Cell Count at Week 96 [Baseline, Week 96]

    11. Change From Baseline in CD4+ Cell Count at Week 144 [Baseline, Week 144]

    12. Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm [Baseline, open-label Week 48]

      The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit.

    13. Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm [Baseline, open-label Week 48]

      The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.

    14. Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm [Baseline, open-label Week 96]

      The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit.

    15. Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm [Baseline, open-label Week 96]

      The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.

    16. Change From Baseline in CD4+ Cell Count at Week 48 Open-Label [Baseline, open-label Week 48]

    17. Change From Baseline in CD4+ Cell Count at Week 96 Open-Label [Baseline, open-label Week 96]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:

    • Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to screening

    • Plasma HIV-1 ribonucleic acid (RNA) levels ≥ 500 copies per milliliter (mL) at screening

    • Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL per minute (min) (≥ 0.50 mL per second (sec)) according to the Cockcroft-Gault formula

    Key Exclusion Criteria:

    • An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening

    • Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)

    • Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance

    • Females who are pregnant (as confirmed by positive serum pregnancy test)

    • Females who are breastfeeding

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Arizona United States 85012
    2 Phoenix Arizona United States 85025
    3 Beverly Hills California United States 90211
    4 Los Angeles California United States 90027
    5 Los Angeles California United States 90036
    6 Los Angeles California United States 90059
    7 Los Angeles California United States 90069
    8 Sacramento California United States 95817
    9 Sacramento California United States 95825
    10 Optimus Medical - ClinEdge - PPDS San Francisco California United States 94102
    11 Kaiser Permanente San Leandro California United States 94577
    12 Denver Colorado United States 80205
    13 Washington District of Columbia United States 20009
    14 Washington District of Columbia United States 20036
    15 Washington District of Columbia United States 20037
    16 DeLand Florida United States 32720
    17 Fort Lauderdale Florida United States 33316
    18 Fort Pierce Florida United States 34982
    19 Miami Beach Florida United States 33139
    20 Miami Florida United States 33133
    21 Miami Florida United States 33136
    22 Oakland Park Florida United States 33306
    23 Orlando Florida United States 32803
    24 Pensacola Florida United States 32504
    25 Tampa Florida United States 33614
    26 West Palm Beach Florida United States 33407
    27 Atlanta Georgia United States 30308
    28 Atlanta Georgia United States 30312
    29 Decatur Georgia United States 30033
    30 Macon Georgia United States 31201
    31 Savannah Georgia United States 31405
    32 Chicago Illinois United States 60613
    33 Chicago Illinois United States 60657
    34 Indianapolis Indiana United States 46202
    35 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    36 Boston Massachusetts United States 02129
    37 Boston Massachusetts United States 02215
    38 Springfield Massachusetts United States 01105
    39 Berkley Michigan United States 48072
    40 Detroit Michigan United States 48202
    41 Kansas City Missouri United States 64111
    42 Saint Louis Missouri United States 63108
    43 Saint Louis Missouri United States 63139
    44 Hillsborough New Jersey United States 08844
    45 Newark New Jersey United States 07102
    46 Albany New York United States 12208
    47 Bronx New York United States 10461
    48 Manhasset New York United States 11030
    49 New York New York United States 10011-4121
    50 New York New York United States 10011
    51 Chapel Hill North Carolina United States 27514
    52 Charlotte North Carolina United States 28207
    53 Cone Health Regional Center for Infectious Disease Greensboro North Carolina United States 27401
    54 Greenville North Carolina United States 27858-4354
    55 Huntersville North Carolina United States 28078
    56 Winston-Salem North Carolina United States 27157
    57 Cincinnati Ohio United States 45267
    58 Philadelphia Pennsylvania United States 19104
    59 Philadelphia Pennsylvania United States 19107
    60 Allegheny Health Network Pittsburgh Pennsylvania United States 15212
    61 Columbia South Carolina United States 29203-6840
    62 Austin Texas United States 78705
    63 Bellaire Texas United States 77401
    64 Dallas Texas United States 75202
    65 AIDS Arms Inc Dallas Texas United States 75215
    66 Dallas Texas United States 75235
    67 North Texas Infectious Diseases Consultants PA Dallas Texas United States 75246
    68 Fort Worth Texas United States 76104
    69 Houston Texas United States 77004
    70 Houston Texas United States 77098
    71 Longview Texas United States 75605
    72 Annandale Virginia United States 22003-7313
    73 Seattle Washington United States 98104
    74 Spokane Washington United States 99204
    75 Sydney New South Wales Australia 2010 NSW
    76 Carlton Victoria Australia 3053
    77 Clayton Victoria Australia 3168
    78 Melbourne Victoria Australia 3004
    79 Prahran Victoria Australia 3068
    80 Prahran Market Clinic Prahran Victoria Australia 3181
    81 Antwerp Belgium 2000
    82 Ghent Belgium B-9000
    83 McGill University Health Center Montreal Canada H4A 3J1
    84 Ottawa Canada K1H 8L6
    85 Sunnybrook Health Sciences Centre Toronto Canada M4N 3M5
    86 Toronto Canada M5G 1K2
    87 Toronto Canada M5G2N2
    88 Winnipeg Canada R3A 1R9
    89 Santo Domingo Dominican Republic 10103
    90 Montpellier France 34295
    91 CHU de Nice Archet I Nice France 06200
    92 Tourcoing France 59200
    93 Tourcoing France 59208
    94 Berlin Germany 12157
    95 Düsseldorf Germany 40237
    96 Essen Germany 45122
    97 Frankfurt Germany 60311
    98 Frankfurt Germany 60590
    99 Hamburg Germany 20146
    100 Uniklinik Köln Köln Germany 50924
    101 München Germany 80335
    102 Bergamo Italy 24127
    103 Milano Italy 20127
    104 Roma Italy
    105 San Juan Puerto Rico 00909-1711
    106 San Juan Puerto Rico 00909
    107 Alicante Spain 3010
    108 Badalona Spain 08907
    109 Madrid Spain 28007
    110 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    111 Madrid Spain 28034
    112 Madrid Spain 28046
    113 Malaga Spain 29010
    114 Vigo Spain 36312
    115 Birmingham United Kingdom B4 6DH
    116 Birmingham United Kingdom B9 5SS
    117 London United Kingdom E1 1BB.
    118 London United Kingdom NW3 2QG
    119 London United Kingdom SE19 3ST
    120 London United Kingdom SE5 9RJ
    121 Chelsea and Westminster NHS Trust London United Kingdom SW10 9NH
    122 St George's Healthcare NHS Trust London United Kingdom SW17 0QT
    123 London United Kingdom WC1E 6JB
    124 Manchester United Kingdom M13 0FH
    125 Manchester United Kingdom M8 5RB

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02607956
    Other Study ID Numbers:
    • GS-US-380-1490
    • 2015-003988-10
    First Posted:
    Nov 18, 2015
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Feb 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 Gilead Sciences
    HIV
    Additional relevant MeSH terms:
    Dolutegravir
    Emtricitabine tenofovir alafenamide

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at centers in Australia, Europe, North America, and the Dominican Republic. The first participant was screened on 11 November 2015. The last study visit occurred on 05 July 2021.
    Pre-assignment Detail 742 participants were screened.
    Arm/Group Title B/F/TAF DTG + F/TAF B/F/TAF to B/F/TAF DTG + F/TAF to B/F/TAF
    Arm/Group Description Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food. DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks without regard to food. After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive open-label (OL) B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
    Period Title: Double-Blinded Phase
    STARTED 327 330 0 0
    COMPLETED 266 277 0 0
    NOT COMPLETED 61 53 0 0
    Period Title: Double-Blinded Phase
    STARTED 0 0 254 265
    COMPLETED 0 0 225 235
    NOT COMPLETED 0 0 29 30

    Baseline Characteristics

    Arm/Group Title B/F/TAF DTG + F/TAF Total
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. Total of all reporting groups
    Overall Participants 320 325 645
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    37
    (12.3)
    37
    (11.6)
    37
    (11.9)
    Sex: Female, Male (Count of Participants)
    Female
    40
    12.5%
    37
    11.4%
    77
    11.9%
    Male
    280
    87.5%
    288
    88.6%
    568
    88.1%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    1
    0.3%
    1
    0.3%
    2
    0.3%
    Asian
    7
    2.2%
    10
    3.1%
    17
    2.6%
    Black
    97
    30.3%
    100
    30.8%
    197
    30.5%
    Native Hawaiian or Pacific Islander
    1
    0.3%
    0
    0%
    1
    0.2%
    White
    183
    57.2%
    195
    60%
    378
    58.6%
    Other
    31
    9.7%
    19
    5.8%
    50
    7.8%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    83
    25.9%
    81
    24.9%
    164
    25.4%
    Not Hispanic or Latino
    237
    74.1%
    244
    75.1%
    481
    74.6%
    Region of Enrollment (Count of Participants)
    Canada
    12
    3.8%
    9
    2.8%
    21
    3.3%
    Belgium
    4
    1.3%
    4
    1.2%
    8
    1.2%
    United States
    193
    60.3%
    193
    59.4%
    386
    59.8%
    Dominican Republic
    27
    8.4%
    18
    5.5%
    45
    7%
    Italy
    15
    4.7%
    18
    5.5%
    33
    5.1%
    United Kingdom
    21
    6.6%
    23
    7.1%
    44
    6.8%
    Australia
    4
    1.3%
    10
    3.1%
    14
    2.2%
    France
    7
    2.2%
    5
    1.5%
    12
    1.9%
    Germany
    20
    6.3%
    28
    8.6%
    48
    7.4%
    Spain
    17
    5.3%
    17
    5.2%
    34
    5.3%
    HIV-1 RNA (log10 copies/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 copies/mL]
    4.39
    (0.730)
    4.42
    (0.669)
    4.41
    (0.700)
    HIV-1 RNA Categories (Count of Participants)
    ≤ 100,000 copies/mL
    254
    79.4%
    271
    83.4%
    525
    81.4%
    > 100,000 ≤ 400,000 copies/mL
    54
    16.9%
    41
    12.6%
    95
    14.7%
    > 400,000 copies/mL
    12
    3.8%
    13
    4%
    25
    3.9%
    CD4 Cell Count (Cells/µL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Cells/µL]
    457
    (255.3)
    454
    (231.5)
    456
    (243.4)
    CD4 Cell Count Categories (Count of Participants)
    < 50 cells/μL
    15
    4.7%
    13
    4%
    28
    4.3%
    ≥ 50 to < 200 cells/μL
    29
    9.1%
    21
    6.5%
    50
    7.8%
    ≥ 200 to < 350 cells/μL
    67
    20.9%
    77
    23.7%
    144
    22.3%
    ≥ 350 to < 500 cells/μL
    91
    28.4%
    94
    28.9%
    185
    28.7%
    ≥ 500 cells/μL
    118
    36.9%
    120
    36.9%
    238
    36.9%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
    Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
    Time Frame Week 48

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 320 325
    Number [percentage of participants]
    89.4
    27.9%
    92.9
    28.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Non-Inferiority
    Comments A sample of approximately 600 participants randomized 1:1 achieves at least 95% power using a non-inferiority margin of 12% assuming a response rate in both groups of 91% (Reference Genvoya studies) and a one-sided alpha level of 0.025.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value -3.5
    Confidence Interval (2-Sided) 95.002%
    -7.9 to 1.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments Differences in percentages of participants between groups and their 95.002% CIs were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.12
    Comments
    Method Cochran-Mantel-Haenszel
    Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    2. Secondary Outcome
    Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
    Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
    Time Frame Week 96

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 320 325
    Number [percentage of participants]
    84.1
    26.3%
    86.5
    26.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value -2.3
    Confidence Interval (2-Sided) 95%
    -7.9 to 3.2
    Parameter Dispersion Type:
    Value:
    Estimation Comments Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.41
    Comments
    Method Cochran-Mantel-Haenszel
    Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    3. Secondary Outcome
    Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
    Description The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
    Time Frame Week 144

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 320 325
    Number [percentage of participants]
    81.9
    25.6%
    84.0
    25.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value -1.9
    Confidence Interval (2-Sided) 95%
    -7.8 to 3.9
    Parameter Dispersion Type:
    Value:
    Estimation Comments Differences in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.52
    Comments
    Method Cochran-Mantel-Haenszel
    Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    4. Secondary Outcome
    Title Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
    Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
    Time Frame Week 48

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 320 325
    Number [percentage of participants]
    82.2
    25.7%
    87.1
    26.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value -3.9
    Confidence Interval (2-Sided) 95%
    -9.4 to 1.5
    Parameter Dispersion Type:
    Value:
    Estimation Comments The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.16
    Comments
    Method Cochran-Mantel-Haenszel
    Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    5. Secondary Outcome
    Title Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
    Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
    Time Frame Week 96

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 320 325
    Number [percentage of participants]
    77.5
    24.2%
    80.3
    24.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value -2.5
    Confidence Interval (2-Sided) 95%
    -8.8 to 3.8
    Parameter Dispersion Type:
    Value:
    Estimation Comments The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.44
    Comments
    Method Cochran-Mantel-Haenszel
    Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    6. Secondary Outcome
    Title Percentage of Participants Who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
    Description The percentage of participants achieving HIV-1 RNA < 20 copies/mL at Week 144 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
    Time Frame Week 144

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 320 325
    Number [percentage of participants]
    77.5
    24.2%
    79.1
    24.3%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter Difference in Percentages
    Estimated Value -1.1
    Confidence Interval (2-Sided) 95%
    -7.4 to 5.3
    Parameter Dispersion Type:
    Value:
    Estimation Comments The differences in percentages of participants between treatment groups and their 95% CIs were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.74
    Comments
    Method Cochran-Mantel-Haenszel
    Comments p-value was calculated from CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL) and region stratum (US vs. Ex-US).
    7. Secondary Outcome
    Title Change From Baseline in log10 HIV-1 RNA at Week 48
    Description
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 294 308
    Mean (Standard Deviation) [log10 copies/mL]
    -3.07
    (0.719)
    -3.12
    (0.672)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.081
    Comments
    Method ANOVA
    Comments p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value 0.08
    Confidence Interval (2-Sided) 95%
    -0.01 to 0.17
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.
    8. Secondary Outcome
    Title Change From Baseline in log10 HIV-1 RNA at Week 96
    Description
    Time Frame Baseline, Week 96

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 276 291
    Mean (Standard Deviation) [log10 copies/mL]
    -3.08
    (0.703)
    -3.10
    (0.713)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.18
    Comments
    Method ANOVA
    Comments p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value 0.06
    Confidence Interval (2-Sided) 95%
    -0.03 to 0.15
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.
    9. Secondary Outcome
    Title Change From Baseline in log10 HIV-1 RNA at Week 144
    Description
    Time Frame Baseline, Week 144

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 270 280
    Mean (Standard Deviation) [log10 copies/mL]
    -3.06
    (0.731)
    -3.11
    (0.672)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.054
    Comments
    Method ANOVA
    Comments p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value 0.09
    Confidence Interval (2-Sided) 95%
    0.00 to 0.18
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.
    10. Secondary Outcome
    Title Change From Baseline in CD4+ Cell Count at Week 48
    Description
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 290 304
    Mean (Standard Deviation) [cells/μL]
    180
    (166.2)
    201
    (165.9)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.096
    Comments
    Method ANOVA
    Comments P-value was adjusted by the baseline HIV-1 RNA and region stratum.
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value -23
    Confidence Interval (2-Sided) 95%
    -49 to 4
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.
    11. Secondary Outcome
    Title Change From Baseline in CD4+ Cell Count at Week 96
    Description
    Time Frame Baseline, Week 96

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 269 285
    Mean (Standard Deviation) [cells/μL]
    237
    (204.2)
    281
    (209.3)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments
    Method ANOVA
    Comments P-value was adjusted by the baseline HIV-1 RNA and region stratum.
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value -47
    Confidence Interval (2-Sided) 95%
    -81 to -12
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.
    12. Secondary Outcome
    Title Change From Baseline in CD4+ Cell Count at Week 144
    Description
    Time Frame Baseline, Week 144

    Outcome Measure Data

    Analysis Population Description
    Participants in the Full Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF DTG + F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 262 277
    Mean (Standard Deviation) [cells/μL]
    278
    (236.6)
    289
    (218.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, DTG + F/TAF
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.48
    Comments
    Method ANOVA
    Comments p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value -14
    Confidence Interval (2-Sided) 95%
    -52 to 25
    Parameter Dispersion Type:
    Value:
    Estimation Comments Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.
    13. Secondary Outcome
    Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded Algorithm
    Description The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit.
    Time Frame Baseline, open-label Week 48

    Outcome Measure Data

    Analysis Population Description
    Participants in All B/F/TAF Analysis Set (who were randomized into the randomized phase of the study and received at least 1 dose of the B/F/TAF in the randomized phase or at least 1 dose of the B/F/TAF in the open label extension phase) with available data were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Missing = Excluded analysis, it included the available participants at that time point from the Randomized Phase.
    Arm/Group Title All B/F/TAF DTG + F/TAF to B/F/TAF
    Arm/Group Description Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food. Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
    Measure Participants 243 225
    Number (95% Confidence Interval) [percentage of participants]
    99.2
    31%
    99.6
    30.6%
    14. Secondary Outcome
    Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm
    Description The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
    Time Frame Baseline, open-label Week 48

    Outcome Measure Data

    Analysis Population Description
    Participants in the All B/F/TAF Analysis Set were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Missing = Failure analysis, it included all participants from the Randomized Phase.
    Arm/Group Title All B/F/TAF DTG + F/TAF to B/F/TAF
    Arm/Group Description Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food. Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
    Measure Participants 320 265
    Number (95% Confidence Interval) [percentage of participants]
    75.3
    23.5%
    84.5
    26%
    15. Secondary Outcome
    Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm
    Description The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Excluded for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). The denominator for percentages at a visit was the number of participants in the all B/F/TAF analysis set with nonmissing HIV-1 RNA value at that visit.
    Time Frame Baseline, open-label Week 96

    Outcome Measure Data

    Analysis Population Description
    Participants in All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Missing = Excluded analysis, it included the available participants at that time point from the Randomized Phase.
    Arm/Group Title All B/F/TAF DTG + F/TAF to B/F/TAF
    Arm/Group Description Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food. Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
    Measure Participants 219 234
    Number (95% Confidence Interval) [percentage of participants]
    99.5
    31.1%
    99.1
    30.5%
    16. Secondary Outcome
    Title Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm
    Description The percentage of participants with HIV-1 RNA < 50 copies/mL was analyzed using Missing = Failure for imputing missing HIV-1 RNA values using the All B/F/TAF Analysis Set for the all B/F/TAF analysis. All missing data was treated as HIV-1 RNA ≥ 50 copies/mL. The denominator for percentages was the number of participants in all B/F/TAF analysis set.
    Time Frame Baseline, open-label Week 96

    Outcome Measure Data

    Analysis Population Description
    Participants in the All B/F/TAF Analysis Set were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Missing = Failure analysis, it included all participants from the Randomized Phase.
    Arm/Group Title All B/F/TAF DTG + F/TAF to B/F/TAF
    Arm/Group Description Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food. Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
    Measure Participants 320 265
    Number (95% Confidence Interval) [percentage of participants]
    68.1
    21.3%
    87.5
    26.9%
    17. Secondary Outcome
    Title Change From Baseline in CD4+ Cell Count at Week 48 Open-Label
    Description
    Time Frame Baseline, open-label Week 48

    Outcome Measure Data

    Analysis Population Description
    Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 48 open-label time point refers to Week 192; for Change from Baseline in CD4 Cell Count analysis, it included the available participants at that time point from the Randomized Phase.
    Arm/Group Title All B/F/TAF DTG + F/TAF to B/F/TAF
    Arm/Group Description Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. Open Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
    Measure Participants 241 223
    Mean (Standard Deviation) [cells/μL]
    304
    (249.2)
    9
    (198.0)
    18. Secondary Outcome
    Title Change From Baseline in CD4+ Cell Count at Week 96 Open-Label
    Description
    Time Frame Baseline, open-label Week 96

    Outcome Measure Data

    Analysis Population Description
    Participants in the All B/F/TAF Analysis Set with available data were analyzed. For the B/F/TAF group, Week 96 open-label time point refers to Week 240; for Change from Baseline in CD4 Cell Count analysis, it included the available participants at that time point from the Randomized Phase.
    Arm/Group Title All B/F/TAF DTG + F/TAF to B/F/TAF
    Arm/Group Description Blinded Phase: Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + dolutegravir (DTG) placebo + F/TAF placebo orally once daily for at least 144 weeks without regard to food. Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. Open-Label Extension Phase: After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
    Measure Participants 210 225
    Mean (Standard Deviation) [cells/µL]
    336
    (235.1)
    -10
    (181.1)

    Adverse Events

    Time Frame Adverse Events: First dose date up to last dose date (maximum: 281.4 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum: 287.1 weeks)
    Adverse Event Reporting Description Adverse Events: Safety Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. All-Cause Mortality: All Randomized Analysis Set included all participants randomized into the study.
    Arm/Group Title B/F/TAF DTG + F/TAF B/F/TAF to B/F/TAF DTG + F/TAF to B/F/TAF
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC + DTG placebo + F/TAF placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: DTG (50 mg) + F/TAF (200/25 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food. After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first. After Week 144, participants continued to take their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, participants were given the option to receive OL B/F/TAF for 96 weeks. After the Week 96 OL Visit, participants in a country where B/F/TAF was not commercially available were given the option to continue OL B/F/TAF until the product became accessible through an access program or until Gilead elected to discontinue the study in that country, whichever occured first.
    All Cause Mortality
    B/F/TAF DTG + F/TAF B/F/TAF to B/F/TAF DTG + F/TAF to B/F/TAF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/327 (1.2%) 4/330 (1.2%) 1/254 (0.4%) 3/265 (1.1%)
    Serious Adverse Events
    B/F/TAF DTG + F/TAF B/F/TAF to B/F/TAF DTG + F/TAF to B/F/TAF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 64/320 (20%) 46/325 (14.2%) 20/254 (7.9%) 32/265 (12.1%)
    Blood and lymphatic system disorders
    Anaemia 2/320 (0.6%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Disseminated intravascular coagulation 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Cardiac disorders
    Angina pectoris 0/320 (0%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Atrial fibrillation 1/320 (0.3%) 1/325 (0.3%) 0/254 (0%) 2/265 (0.8%)
    Atrial flutter 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Cardiac arrest 2/320 (0.6%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Cardiac failure congestive 2/320 (0.6%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Hypertensive heart disease 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Myocardial infarction 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Supraventricular tachycardia 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Endocrine disorders
    Goitre 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Thyroid mass 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Eye disorders
    Blindness 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Iridocyclitis 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Gastrointestinal disorders
    Abdominal pain 1/320 (0.3%) 1/325 (0.3%) 1/254 (0.4%) 0/265 (0%)
    Abdominal pain upper 1/320 (0.3%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Anal fissure 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Anal fistula 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Anal ulcer 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Colitis 1/320 (0.3%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Constipation 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Diarrhoea 1/320 (0.3%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Gastritis 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Gastrointestinal haemorrhage 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Haemorrhoids 1/320 (0.3%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Hiatus hernia 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Nausea 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Pancreatitis acute 2/320 (0.6%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Proctalgia 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Proctitis 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Rectal haemorrhage 0/320 (0%) 2/325 (0.6%) 0/254 (0%) 0/265 (0%)
    Upper gastrointestinal haemorrhage 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Volvulus 0/320 (0%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Vomiting 1/320 (0.3%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    General disorders
    Chest pain 1/320 (0.3%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Death 0/320 (0%) 2/325 (0.6%) 1/254 (0.4%) 2/265 (0.8%)
    Hyperthermia 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Multiple organ dysfunction syndrome 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Oedema peripheral 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Pyrexia 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Systemic inflammatory response syndrome 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Hepatobiliary disorders
    Cholecystitis acute 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Infections and infestations
    Abscess limb 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Abscess neck 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Amoebic dysentery 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Anal abscess 3/320 (0.9%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Anal infection 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Appendicitis 3/320 (0.9%) 2/325 (0.6%) 0/254 (0%) 1/265 (0.4%)
    Bacterial infection 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Blister infected 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Bronchitis 0/320 (0%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Cellulitis 6/320 (1.9%) 1/325 (0.3%) 1/254 (0.4%) 2/265 (0.8%)
    Covid-19 0/320 (0%) 0/325 (0%) 2/254 (0.8%) 1/265 (0.4%)
    Endocarditis 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Enteritis infectious 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Erysipelas 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Escherichia bacteraemia 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Eye infection syphilitic 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Gastroenteritis 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Gastroenteritis shigella 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Gastroenteritis viral 0/320 (0%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Hepatitis A 1/320 (0.3%) 0/325 (0%) 1/254 (0.4%) 1/265 (0.4%)
    Herpes zoster 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Influenza 1/320 (0.3%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Localised infection 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Orchitis 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Osteomyelitis 0/320 (0%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Perirectal abscess 0/320 (0%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Pharyngitis streptococcal 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Pilonidal cyst 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Pneumonia 1/320 (0.3%) 4/325 (1.2%) 2/254 (0.8%) 2/265 (0.8%)
    Pneumonia parainfluenzae viral 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Pyelonephritis 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Sepsis 1/320 (0.3%) 2/325 (0.6%) 0/254 (0%) 1/265 (0.4%)
    Septic shock 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Shigella infection 2/320 (0.6%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Skin infection 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Staphylococcal infection 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Subcutaneous abscess 1/320 (0.3%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Urinary tract infection 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Urosepsis 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Wound infection 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Injury, poisoning and procedural complications
    Alcohol poisoning 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Concussion 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Fall 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Foot fracture 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Gun shot wound 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Hand fracture 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Head injury 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Heat stroke 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Lower limb fracture 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Radius fracture 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Rectal injury 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Rib fracture 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Road traffic accident 0/320 (0%) 2/325 (0.6%) 0/254 (0%) 0/265 (0%)
    Subdural haematoma 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Tendon injury 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Toxicity to various agents 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Ulna fracture 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Wound dehiscence 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Investigations
    Transaminases increased 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Metabolism and nutrition disorders
    Dehydration 1/320 (0.3%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Diabetes mellitus inadequate control 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Fluid overload 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Hyperglycaemia 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Hyperkalaemia 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Hypoglycaemia 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Hypokalaemia 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Metabolic acidosis 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Back pain 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Bursitis 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Cervical spinal stenosis 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Hip deformity 0/320 (0%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Intervertebral disc displacement 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Intervertebral disc protrusion 2/320 (0.6%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Muscle haemorrhage 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Muscle tightness 0/320 (0%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Pain in extremity 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Rhabdomyolysis 3/320 (0.9%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Spinal osteoarthritis 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Vertebral foraminal stenosis 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Anogenital warts 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    B-cell lymphoma 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Bladder cancer 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Central nervous system lymphoma 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Colon cancer 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Hodgkin's disease 0/320 (0%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Invasive ductal breast carcinoma 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Lung neoplasm malignant 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Lymphoma 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Malignant melanoma 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Pleomorphic adenoma 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Prostate cancer 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 1/265 (0.4%)
    Thyroid cancer 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Nervous system disorders
    Bell's palsy 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Cerebrovascular accident 0/320 (0%) 2/325 (0.6%) 0/254 (0%) 0/265 (0%)
    Cervical radiculopathy 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Cubital tunnel syndrome 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Dizziness 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Headache 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Ischaemic stroke 0/320 (0%) 1/325 (0.3%) 1/254 (0.4%) 0/265 (0%)
    Loss of consciousness 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Seizure 1/320 (0.3%) 0/325 (0%) 1/254 (0.4%) 0/265 (0%)
    Syncope 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Vertebral artery stenosis 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Pregnancy, puerperium and perinatal conditions
    Abortion incomplete 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Psychiatric disorders
    Acute psychosis 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Bipolar disorder 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Depression 1/320 (0.3%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Depression suicidal 1/320 (0.3%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Drug abuse 1/320 (0.3%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Major depression 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Psychotic disorder 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Seasonal affective disorder 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Stress 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Substance use disorder 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Substance-induced psychotic disorder 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Suicide attempt 2/320 (0.6%) 1/325 (0.3%) 1/254 (0.4%) 1/265 (0.4%)
    Renal and urinary disorders
    Acute kidney injury 3/320 (0.9%) 2/325 (0.6%) 0/254 (0%) 0/265 (0%)
    Chronic kidney disease 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Haematuria 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Reproductive system and breast disorders
    Ovarian cyst 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Chronic obstructive pulmonary disease 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Cough 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Dyspnoea 1/320 (0.3%) 2/325 (0.6%) 0/254 (0%) 1/265 (0.4%)
    Interstitial lung disease 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Pneumothorax 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Pulmonary embolism 1/320 (0.3%) 1/325 (0.3%) 1/254 (0.4%) 0/265 (0%)
    Pulmonary mass 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Tonsillar disorder 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Skin and subcutaneous tissue disorders
    Skin ulcer 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Surgical and medical procedures
    Oesophagogastric fundoplasty 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Vascular disorders
    Deep vein thrombosis 2/320 (0.6%) 2/325 (0.6%) 0/254 (0%) 0/265 (0%)
    Hypertension 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Hypertensive crisis 0/320 (0%) 1/325 (0.3%) 0/254 (0%) 0/265 (0%)
    Hypertensive emergency 0/320 (0%) 0/325 (0%) 0/254 (0%) 1/265 (0.4%)
    Peripheral arterial occlusive disease 1/320 (0.3%) 0/325 (0%) 0/254 (0%) 0/265 (0%)
    Other (Not Including Serious) Adverse Events
    B/F/TAF DTG + F/TAF B/F/TAF to B/F/TAF DTG + F/TAF to B/F/TAF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 250/320 (78.1%) 262/325 (80.6%) 165/254 (65%) 163/265 (61.5%)
    Blood and lymphatic system disorders
    Lymphadenopathy 24/320 (7.5%) 23/325 (7.1%) 5/254 (2%) 3/265 (1.1%)
    Gastrointestinal disorders
    Abdominal pain 23/320 (7.2%) 23/325 (7.1%) 4/254 (1.6%) 7/265 (2.6%)
    Abdominal pain upper 16/320 (5%) 13/325 (4%) 5/254 (2%) 2/265 (0.8%)
    Constipation 16/320 (5%) 15/325 (4.6%) 4/254 (1.6%) 3/265 (1.1%)
    Diarrhoea 66/320 (20.6%) 54/325 (16.6%) 15/254 (5.9%) 15/265 (5.7%)
    Dyspepsia 21/320 (6.6%) 14/325 (4.3%) 2/254 (0.8%) 5/265 (1.9%)
    Nausea 31/320 (9.7%) 43/325 (13.2%) 8/254 (3.1%) 11/265 (4.2%)
    Toothache 16/320 (5%) 9/325 (2.8%) 5/254 (2%) 3/265 (1.1%)
    Vomiting 23/320 (7.2%) 22/325 (6.8%) 5/254 (2%) 5/265 (1.9%)
    General disorders
    Fatigue 29/320 (9.1%) 37/325 (11.4%) 4/254 (1.6%) 13/265 (4.9%)
    Pyrexia 21/320 (6.6%) 31/325 (9.5%) 6/254 (2.4%) 9/265 (3.4%)
    Infections and infestations
    Anal chlamydia infection 18/320 (5.6%) 18/325 (5.5%) 11/254 (4.3%) 8/265 (3%)
    Bronchitis 15/320 (4.7%) 28/325 (8.6%) 10/254 (3.9%) 7/265 (2.6%)
    Chlamydial infection 14/320 (4.4%) 26/325 (8%) 5/254 (2%) 6/265 (2.3%)
    Covid-19 0/320 (0%) 0/325 (0%) 26/254 (10.2%) 31/265 (11.7%)
    Gastroenteritis 15/320 (4.7%) 18/325 (5.5%) 5/254 (2%) 8/265 (3%)
    Gonorrhoea 18/320 (5.6%) 24/325 (7.4%) 2/254 (0.8%) 4/265 (1.5%)
    Influenza 27/320 (8.4%) 24/325 (7.4%) 15/254 (5.9%) 11/265 (4.2%)
    Nasopharyngitis 51/320 (15.9%) 62/325 (19.1%) 19/254 (7.5%) 22/265 (8.3%)
    Pharyngitis 22/320 (6.9%) 11/325 (3.4%) 4/254 (1.6%) 1/265 (0.4%)
    Proctitis gonococcal 12/320 (3.8%) 17/325 (5.2%) 3/254 (1.2%) 8/265 (3%)
    Sinusitis 25/320 (7.8%) 10/325 (3.1%) 10/254 (3.9%) 5/265 (1.9%)
    Syphilis 34/320 (10.6%) 33/325 (10.2%) 20/254 (7.9%) 17/265 (6.4%)
    Upper respiratory tract infection 44/320 (13.8%) 54/325 (16.6%) 15/254 (5.9%) 17/265 (6.4%)
    Urinary tract infection 19/320 (5.9%) 14/325 (4.3%) 3/254 (1.2%) 9/265 (3.4%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 36/320 (11.3%) 33/325 (10.2%) 16/254 (6.3%) 17/265 (6.4%)
    Back pain 30/320 (9.4%) 44/325 (13.5%) 18/254 (7.1%) 12/265 (4.5%)
    Pain in extremity 27/320 (8.4%) 11/325 (3.4%) 8/254 (3.1%) 13/265 (4.9%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts 18/320 (5.6%) 11/325 (3.4%) 1/254 (0.4%) 6/265 (2.3%)
    Nervous system disorders
    Dizziness 17/320 (5.3%) 20/325 (6.2%) 7/254 (2.8%) 5/265 (1.9%)
    Headache 57/320 (17.8%) 59/325 (18.2%) 16/254 (6.3%) 19/265 (7.2%)
    Psychiatric disorders
    Anxiety 16/320 (5%) 26/325 (8%) 9/254 (3.5%) 9/265 (3.4%)
    Depression 21/320 (6.6%) 26/325 (8%) 9/254 (3.5%) 9/265 (3.4%)
    Insomnia 29/320 (9.1%) 25/325 (7.7%) 8/254 (3.1%) 14/265 (5.3%)
    Respiratory, thoracic and mediastinal disorders
    Cough 28/320 (8.8%) 30/325 (9.2%) 16/254 (6.3%) 9/265 (3.4%)
    Nasal congestion 17/320 (5.3%) 11/325 (3.4%) 4/254 (1.6%) 1/265 (0.4%)
    Oropharyngeal pain 20/320 (6.3%) 19/325 (5.8%) 8/254 (3.1%) 7/265 (2.6%)
    Skin and subcutaneous tissue disorders
    Rash 15/320 (4.7%) 27/325 (8.3%) 7/254 (2.8%) 11/265 (4.2%)
    Vascular disorders
    Hypertension 19/320 (5.9%) 22/325 (6.8%) 4/254 (1.6%) 8/265 (3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or The study has been completed at all study sites for at least 2 years

    Results Point of Contact

    Name/Title Gilead Clinical Study Information Center
    Organization Gilead Sciences
    Phone 1-833-445-3230 (GILEAD-0)
    Email GileadClinicalTrials@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02607956
    Other Study ID Numbers:
    • GS-US-380-1490
    • 2015-003988-10
    First Posted:
    Nov 18, 2015
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Feb 1, 2022