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

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02607930
Collaborator
(none)
631
Enrollment
121
Locations
4
Arms
67.6
Actual Duration (Months)
5.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The 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 a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naive-adults.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
631 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 Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Actual Study Start Date :
Nov 13, 2015
Actual Primary Completion Date :
May 9, 2017
Actual Study Completion Date :
Jul 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: B/F/TAF

B/F/TAF + ABC/DTG/3TC placebo administered without regard to food for at least 144 weeks.

Drug: B/F/TAF
50/200/25 mg tablets administered orally, once daily, without regard to food
Other Names:
  • GS-9883/F/TAF
  • Biktarvy®

    • Drug: ABC/DTG/3TC Placebo
    Tablets administered orally, once daily
    Active Comparator: ABC/DTG/3TC

    ABC/DTG/3TC + B/F/TAF placebo administered without regard to food for at least 144 weeks.

    Drug: ABC/DTG/3TC
    600/50/300 milligrams (mg) tablets administered orally, once daily
    Other Names:
  • Triumeq®

    • Drug: B/F/TAF Placebo
    Tablets administered orally, once daily
    Experimental: Open-label Phase B/F/TAF to 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 mg tablets administered orally, once daily, without regard to food
    Other Names:
  • GS-9883/F/TAF
  • Biktarvy®

    		•
    Experimental: Open-label Phase ABC/DTG/3TC to 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 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 mg tablets administered orally, once daily, without regard to food
    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 Change From Baseline in Hip BMD at Week 48 [Baseline, Week 48]

    13. Percentage Change From Baseline in Hip BMD at Week 96 [Baseline, Week 96]

    14. Percentage Change From Baseline in Hip BMD at Week 144 [Baseline, Week 144]

    15. Percentage Change From Baseline in Spine BMD at Week 48 [Baseline, Week 48]

    16. Percentage Change From Baseline in Spine BMD at Week 96 [Baseline, Week 96]

    17. Percentage Change From Baseline in Spine BMD at Week 144 [Baseline, Week 144]

    18. 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. 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 non-missing HIV-1 RNA value at that visit.

    19. 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. 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.

    20. 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. 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 non-missing HIV-1 RNA value at that visit.

    21. 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. 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.

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

    23. 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 ≥ 50 milliliter per minute (mL/min) (≥ 0.83 milliliter per second [mL/sec]) according to the Cockcroft-Gault formula

    • Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by Gilead Sciences

    Key Exclusion Criteria:

    • An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening (refer to study protocol)

    • Decompensated cirrhosis (e.g, 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

    • Chronic Hepatitis B Virus (HBV) infection

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294-2050
    2 Spectrum Medical Group Phoenix Arizona United States 85012
    3 Pueblo Family Physicians Phoenix Arizona United States 85015
    4 Kaiser Permanente Medical Center Los Angeles California United States 90027
    5 Ruane Clinical Research Group, Inc. Los Angeles California United States 90036
    6 Anthony Martin Mills MD A Medical Corporation, DBA Mills Clinical Research Los Angeles California United States 90069
    7 Alameda Health System- Highland Hospital Oakland California United States 94602
    8 University of California Davis Sacramento California United States 95817
    9 Kaiser Permanente Medical Group Sacramento California United States 95825
    10 La Playa Medical Group San Diego California United States 92103
    11 Kaiser Permanente San Francisco California United States 94118
    12 Kaiser Permanente San Leandro California United States 94577
    13 The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Center Torrance California United States 90502
    14 Apex Research Denver Colorado United States 80209
    15 Whitman-Walker Institute Washington District of Columbia United States 20009
    16 Providence Hospital - DC Washington District of Columbia United States 20017
    17 Capital Medical Associates Washington District of Columbia United States 20036
    18 Medical Faculty Associates Washington District of Columbia United States 20037
    19 Therafirst Medical Center Fort Lauderdale Florida United States 33308
    20 Gary J. Richmond, M.D., P.A. Fort Lauderdale Florida United States 33316
    21 Midway Immunology and Research Center Fort Pierce Florida United States 34982
    22 AHF Kinder Medical Group Miami Florida United States 33133
    23 Miami Florida United States 33140
    24 Orlando Immunology Center Orlando Florida United States 32803
    25 AIDS Healthcare Foundation-Miami Beach Pensacola Florida United States 32504
    26 St. Joseph's Comprehensive Research Institute Tampa Florida United States 33614
    27 AIDS Research and Treatment Center of the Treasure Coast Vero Beach Florida United States 32960
    28 Triple O Research Institute PA West Palm Beach Florida United States 33401
    29 Emory University Atlanta Georgia United States 30308
    30 Atlanta Infectious Disease Group PC Atlanta Georgia United States 30309
    31 Aids Research Consortium of Atlanta Inc Atlanta Georgia United States 30312
    32 Augusta University Augusta Georgia United States 30912
    33 Infectious Disease Specialists of Atlanta Decatur Georgia United States 30033
    34 Chatham County Health Department Savannah Georgia United States 31401
    35 Indiana CTSI Clinical Research Center Indianapolis Indiana United States 46202
    36 Louisiana State University Health Sciences Center New Orleans Louisiana United States 70112
    37 Baystate Medical Center Springfield Massachusetts United States 01199
    38 Be Well Medical Center Berkley Michigan United States 48072
    39 Henry Ford Health System Detroit Michigan United States 48202
    40 Hennepin County Medical Center Minneapolis Minnesota United States 55415
    41 Kansas City CARE Clinic Kansas City Missouri United States 64111
    42 Southampton Clinical Research Group, Inc. Saint Louis Missouri United States 63108
    43 Southampton Healthcare Inc Saint Louis Missouri United States 63139
    44 Prime healthcare services - St Michael's LLC d/b/a Saint Michael's medical center Newark New Jersey United States 07102
    45 South Jersey Infectious Disease Somers Point New Jersey United States 08244
    46 Santa Fe New Mexico United States 87505
    47 Upstate Infectious Disease Associates Albany New York United States 12208
    48 Bronx Care Bronx New York United States 10457
    49 Montefiore Medical Center Bronx New York United States 10467-2490
    50 Evergreen Health Buffalo New York United States 14215
    51 North Shore University Hospital-(Manhasset) Manhasset New York United States 11030
    52 Aids Research Consortium of Atlanta Inc Chapel Hill North Carolina United States 27514
    53 ID Consultants PA Charlotte North Carolina United States 28209
    54 Greensboro North Carolina United States 27401
    55 East Carolina University Greenville North Carolina United States 27858-4354
    56 Rosedale Infectious Diseases Huntersville North Carolina United States 28078
    57 Wake Forest Baptist Medical Center - PPDS Winston-Salem North Carolina United States 27157-1042
    58 Summa Health System Akron Ohio United States 44304
    59 University of Cincinnati Cincinnati Ohio United States 45267
    60 MetroHealth Research Institute Cleveland Ohio United States 44109
    61 Ohio State University Medical Center Columbus Ohio United States 43210
    62 Perelman Center for Advanced Medicine Philadelphia Pennsylvania United States 19104
    63 Philadelphia FIGHT Philadelphia Pennsylvania United States 19107
    64 Allegheny Health Network Pittsburgh Pennsylvania United States 15212
    65 Medical University of South Carolina PPDS Columbia South Carolina United States 29203-6840
    66 Central Texas Clinical Research Austin Texas United States 78705
    67 Saint Hope Foundation Inc Bellaire Texas United States 77401
    68 AIDS Arms Inc Dallas Texas United States 75215
    69 UT Southwestern Clinical Trials Office Dallas Texas United States 75235
    70 North Texas Infectious Diseases Consultants PA Dallas Texas United States 75246
    71 Fort Worth Texas United States 76104
    72 Therapeutic Concepts Houston Texas United States 77004
    73 Gordon E Crofoot MD PA Houston Texas United States 77098
    74 Research Access Network Houston Texas United States 77098
    75 Diagnostic Clinic of Longview Center For Clinical Research (DCOL) Longview Texas United States 75605
    76 Peter Shalit MD Seattle Washington United States 98104
    77 Multicare Rockwood HIV Critical Care Clinic Spokane Washington United States 99204
    78 The Medical College of Wisconsin, Inc. Milwaukee Wisconsin United States 53226
    79 Cliniques Universitaires Saint-Luc Brussels Belgium 1200
    80 UZ Gent Ghent Belgium B-9000
    81 Clinique Medicale L'actuel Montreal Canada H2L 5B1
    82 McGill University Health Center Montreal Canada H2X 2P4
    83 Clinique OPUS Inc Montreal Canada H3A 1T1
    84 Ottawa Hospital Ottawa Canada K1H 8L6
    85 Sunnybrook Health Sciences Centre Toronto Canada M4N 3M5
    86 Maple Leaf Research Toronto Canada M5G 1K2
    87 Spectrum Health Care Vancouver Canada V6Z 2T1
    88 Winnipeg Regional Health Authority Winnipeg Canada R3A 1R9
    89 Instituto Dominicano de Estudios Virologicos IDEV Santo Domingo Dominican Republic 10103
    90 Hôpital de La Croix Rousse Lyon cedex 04 France 69317
    91 CHU de Nice Archet I Nice France 06200
    92 Hôpital Saint Louis PARIS cedex 10 France 75475
    93 Paris France 75018
    94 Hôpital Saint Antoine Paris France 75571
    95 Groupe Hospitalier Bichat Claude Bernard Tourcoing France 59208
    96 zibp Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH Berlin Germany 13353
    97 Universitätsklinikum Bonn Bonn Germany 53127
    98 ICH Study Center Hamburg Germany 20146
    99 ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy 24127
    100 Ospedale San Raffaele S.r.l. - PPDS Milano Italy 20127
    101 Istituto Nazionale Malattie Infettive Lazzaro Spallanzani IRCCS Roma Italy
    102 Hope Clinical Research San Juan Puerto Rico 00909
    103 University of Puerto Rico San Juan Puerto Rico 00935
    104 Hospital Universitario Germans Trias i Pujol Badalona Barcelona Spain 08916
    105 Hospital General Universitario de Alicante Alicante Spain 3010
    106 Hospital Universitario de Bellvitge Badalona Spain 08907
    107 Hospital Clinic de Barcelona Barcelona Spain 08036
    108 C.H. Regional Reina Sofia - PPDS Cordoba Spain 14004
    109 Hospital Universitario Ramon y Cajal Madrid Spain 28034
    110 Hospital Clinico San Carlos Madrid Spain 28040
    111 Hospital Universitario 12 de Octubre Madrid Spain 28041
    112 Hospital Universitario La Paz - PPDS Madrid Spain 28046
    113 CHUVI - H.U. Alvaro Cunqueiro Vigo Spain 36312
    114 University Hospitals Birmingham NHS Foundation Trust Birmingham United Kingdom B4 6DH
    115 Brighton and Sussex University Hospitals NHS Trust Brighton United Kingdom BN2 3EW
    116 Barts Health NHS Trust, Royal London Hospital, Ambrose King Centre London United Kingdom E1 1BB
    117 Royal Free London NHS Foundation Trust London United Kingdom NW3 2QG
    118 Kings College Hospital London United Kingdom SE5 9RJ
    119 Chelsea and Westminster NHS Trust London United Kingdom SW10 9TH
    120 Mortimer Market Centre London United Kingdom WC1E 6JB
    121 North Manchester General Hospital - PPDS 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:
    NCT02607930
    Other Study ID Numbers:
    • GS-US-380-1489
    • 2015-004024-54
    First Posted:
    Nov 18, 2015
    Last Update Posted:
    Mar 2, 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:
    Lamivudine
    Triumeq

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study centers in Europe, Dominican Republic, and North America. The first participant was screened on 13 November 2015. The last study visit occurred on 02 July 2021.
    Pre-assignment Detail 739 participants were screened.
    Arm/Group Title B/F/TAF ABC/DTG/3TC B/F/TAF to B/F/TAF ABC/DTG/3TC to B/F/TAF
    Arm/Group Description Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) tablets fixed-dose combination (FDC) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) placebo orally once daily for at least 144 weeks, without regard to food. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for 144 weeks, without regard to food. After Week 144, participants continued 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 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 attend 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.
    Period Title: Double-Blinded Treatment Phase
    STARTED 316 315 0 0
    COMPLETED 262 262 0 0
    NOT COMPLETED 54 53 0 0
    Period Title: Double-Blinded Treatment Phase
    STARTED 0 0 252 254
    COMPLETED 0 0 218 221
    NOT COMPLETED 0 0 34 33

    Baseline Characteristics

    Arm/Group Title B/F/TAF ABC/DTG/3TC Total
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food Open-Label Extension Phase: 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. Blinded Phase: ABC/DTG/3TC (600/50/300 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 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. Total of all reporting groups
    Overall Participants 314 315 629
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    34
    (10.9)
    34
    (10.8)
    34
    (10.8)
    Sex: Female, Male (Count of Participants)
    Female
    29
    9.2%
    33
    10.5%
    62
    9.9%
    Male
    285
    90.8%
    282
    89.5%
    567
    90.1%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian or Alaska Native
    2
    0.6%
    4
    1.3%
    6
    1%
    Asian
    6
    1.9%
    10
    3.2%
    16
    2.5%
    Black
    114
    36.3%
    112
    35.6%
    226
    35.9%
    Native Hawaiian or Pacific Islander
    1
    0.3%
    2
    0.6%
    3
    0.5%
    White
    180
    57.3%
    179
    56.8%
    359
    57.1%
    Other
    9
    2.9%
    8
    2.5%
    17
    2.7%
    Not Permitted
    2
    0.6%
    0
    0%
    2
    0.3%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    72
    22.9%
    65
    20.6%
    137
    21.8%
    Not Hispanic or Latino
    240
    76.4%
    249
    79%
    489
    77.7%
    Not Permitted
    2
    0.6%
    1
    0.3%
    3
    0.5%
    Region of Enrollment (Count of Participants)
    Canada
    18
    5.7%
    15
    4.8%
    33
    5.2%
    Belgium
    4
    1.3%
    2
    0.6%
    6
    1%
    United States
    228
    72.6%
    233
    74%
    461
    73.3%
    Dominican Republic
    2
    0.6%
    1
    0.3%
    3
    0.5%
    Italy
    7
    2.2%
    11
    3.5%
    18
    2.9%
    United Kingdom
    20
    6.4%
    11
    3.5%
    31
    4.9%
    France
    11
    3.5%
    10
    3.2%
    21
    3.3%
    Germany
    4
    1.3%
    9
    2.9%
    13
    2.1%
    Spain
    20
    6.4%
    23
    7.3%
    43
    6.8%
    HIV-1 RNA (log10 copies/mL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [log10 copies/mL]
    4.41
    (0.647)
    4.42
    (0.685)
    4.42
    (0.665)
    HIV-1 RNA Categories (Count of Participants)
    ≤ 100,000 copies/mL
    261
    83.1%
    265
    84.1%
    526
    83.6%
    > 100,000 ≤ 400,000 copies/mL
    45
    14.3%
    38
    12.1%
    83
    13.2%
    > 400,000 copies/mL
    8
    2.5%
    12
    3.8%
    20
    3.2%
    CD4 Cell Count (Cells/µL) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Cells/µL]
    453
    (220.8)
    476
    (231.4)
    464
    (226.3)
    CD4 Cell Count Categories (Count of Participants)
    < 50 Cells/µL
    7
    2.2%
    10
    3.2%
    17
    2.7%
    ≥ 50 to < 200 Cells/µL
    29
    9.2%
    22
    7%
    51
    8.1%
    ≥ 200 to < 350 Cells/µL
    69
    22%
    58
    18.4%
    127
    20.2%
    ≥ 350 to < 500 Cells/µL
    87
    27.7%
    91
    28.9%
    178
    28.3%
    ≥ 500 Cells/µL
    122
    38.9%
    134
    42.5%
    256
    40.7%
    Hip Bone Mineral Density (BMD) (g/cm^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [g/cm^2]
    1.048
    (0.1572)
    1.057
    (0.1520)
    1.052
    (0.1546)
    Spine BMD (g/cm^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [g/cm^2]
    1.139
    (0.1847)
    1.142
    (0.1713)
    1.140
    (0.1780)

    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 314 315
    Number [percentage of participants]
    92.4
    29.4%
    93.0
    29.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    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 -0.6
    Confidence Interval (2-Sided) 95.002%
    -4.8 to 3.6
    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, ABC/DTG/3TC
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.78
    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 314 315
    Number [percentage of participants]
    87.9
    28%
    89.8
    28.5%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    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%
    -6.9 to 3.1
    Parameter Dispersion Type:
    Value:
    Estimation Comments Differences in percentages of participants between groups and their 95% 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, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.45
    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 314 315
    Number [percentage of participants]
    81.5
    26%
    84.1
    26.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    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 -2.6
    Confidence Interval (2-Sided) 95%
    -8.5 to 3.4
    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, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.39
    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 314 315
    Number [percentage of participants]
    87.6
    27.9%
    87.3
    27.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    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 0.4
    Confidence Interval (2-Sided) 95%
    -4.8 to 5.6
    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, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.87
    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 314 315
    Number [percentage of participants]
    83.4
    26.6%
    84.8
    26.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    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 -1.2
    Confidence Interval (2-Sided) 95%
    -6.9 to 4.6
    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, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.69
    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 314 315
    Number [percentage of participants]
    78.0
    24.8%
    82.2
    26.1%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    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 -4.2
    Confidence Interval (2-Sided) 95%
    -10.5 to 2.1
    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, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.19
    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 295 302
    Mean (Standard Deviation) [log10 copies/mL]
    -3.11
    (0.641)
    -3.07
    (0.738)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    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 -0.03
    Confidence Interval (2-Sided) 95%
    -0.12 to 0.06
    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 279 288
    Mean (Standard Deviation) [log10 copies/mL]
    -3.09
    (0.643)
    -3.10
    (0.705)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.99
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value 0.00
    Confidence Interval (2-Sided) 95%
    -0.09 to 0.09
    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 260 269
    Mean (Standard Deviation) [log10 copies/mL]
    -3.11
    (0.639)
    -3.10
    (0.681)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.88
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value 0.01
    Confidence Interval (2-Sided) 95%
    -0.08 to 0.10
    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 294 300
    Mean (Standard Deviation) [cells/µL]
    235
    (185.8)
    228
    (188.7)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.69
    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 6
    Confidence Interval (2-Sided) 95%
    -24 to 36
    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 276 286
    Mean (Standard Deviation) [cells/µL]
    287
    (206.9)
    288
    (246.8)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.94
    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 -1
    Confidence Interval (2-Sided) 95%
    -39 to 36
    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 ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 255 260
    Mean (Standard Deviation) [cells/µL]
    299
    (224.9)
    317
    (219.5)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.30
    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 -20
    Confidence Interval (2-Sided) 95%
    -59 to 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.
    13. Secondary Outcome
    Title Percentage Change From Baseline in Hip BMD at Week 48
    Description
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Participants in the Hip DXA Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 278 281
    Mean (Standard Deviation) [percentage change]
    -0.802
    (2.3280)
    -1.148
    (2.5126)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.092
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value 0.346
    Confidence Interval (2-Sided) 95%
    -0.057 to 0.748
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    14. Secondary Outcome
    Title Percentage Change From Baseline in Hip BMD at Week 96
    Description
    Time Frame Baseline, Week 96

    Outcome Measure Data

    Analysis Population Description
    Participants in the Hip DXA Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 250 257
    Mean (Standard Deviation) [percentage change]
    -1.128
    (2.7702)
    -1.262
    (2.8524)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.59
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value 0.135
    Confidence Interval (2-Sided) 95%
    -0.356 to 0.625
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    15. Secondary Outcome
    Title Percentage Change From Baseline in Hip BMD at Week 144
    Description
    Time Frame Baseline, Week 144

    Outcome Measure Data

    Analysis Population Description
    Participants in the Hip DXA Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 236 240
    Mean (Standard Deviation) [percentage change]
    -1.020
    (3.7638)
    -1.291
    (3.1140)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.39
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value 0.271
    Confidence Interval (2-Sided) 95%
    -0.351 to 0.893
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Percentage Change From Baseline in Spine BMD at Week 48
    Description
    Time Frame Baseline, Week 48

    Outcome Measure Data

    Analysis Population Description
    Participants in the Spine DXA Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 284 285
    Mean (Standard Deviation) [percentage change]
    -0.772
    (3.2228)
    -0.552
    (3.0956)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.41
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value -0.221
    Confidence Interval (2-Sided) 95%
    -0.741 to 0.300
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    17. Secondary Outcome
    Title Percentage Change From Baseline in Spine BMD at Week 96
    Description
    Time Frame Baseline, Week 96

    Outcome Measure Data

    Analysis Population Description
    Participants in the Spine DXA Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 256 258
    Mean (Standard Deviation) [percentage change]
    -0.705
    (3.8721)
    -0.219
    (3.5159)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.14
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value -0.485
    Confidence Interval (2-Sided) 95%
    -1.126 to 0.155
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    18. Secondary Outcome
    Title Percentage Change From Baseline in Spine BMD at Week 144
    Description
    Time Frame Baseline, Week 144

    Outcome Measure Data

    Analysis Population Description
    Participants in the Spine DXA Analysis Set with available data were analyzed.
    Arm/Group Title B/F/TAF ABC/DTG/3TC
    Arm/Group Description Blinded Phase: B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. Blinded Phase: ABC/DTG/3TC (600/50/300 mg) FDC tablet + B/F/TAF placebo orally once daily for at least 144 weeks, without regard to food.
    Measure Participants 243 244
    Mean (Standard Deviation) [percentage change]
    -0.371
    (4.4369)
    0.035
    (3.5182)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection B/F/TAF, ABC/DTG/3TC
    Comments
    Type of Statistical Test Other
    Comments
    Statistical Test of Hypothesis p-Value 0.26
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter Difference in LSM
    Estimated Value -0.406
    Confidence Interval (2-Sided) 95%
    -1.119 to 0.307
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    19. 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. 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 non-missing 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 ABC/DTG/3TC 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) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) 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 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. 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 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.
    Measure Participants 237 212
    Number (95% Confidence Interval) [percentage of participants]
    99.2
    31.6%
    100
    31.7%
    20. 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. 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 ABC/DTG/3TC 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) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) 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 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. 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 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.
    Measure Participants 314 254
    Number (95% Confidence Interval) [percentage of participants]
    74.8
    23.8%
    83.5
    26.5%
    21. 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. 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 non-missing HIV-1 RNA value at that visit.
    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 Missing = Excluded analysis, it included the available participants at that time point from the Randomized Phase.
    Arm/Group Title All B/F/TAF ABC/DTG/3TC 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) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) 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 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. 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 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.
    Measure Participants 213 218
    Number (95% Confidence Interval) [percentage of participants]
    97.7
    31.1%
    99.5
    31.6%
    22. 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. 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 ABC/DTG/3TC 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) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) 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 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. 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 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.
    Measure Participants 314 254
    Number (95% Confidence Interval) [percentage of participants]
    66.2
    21.1%
    85.4
    27.1%
    23. 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 ABC/DTG/3TC 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) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) 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 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. 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 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.
    Measure Participants 234 212
    Mean (Standard Deviation) [cells/µL]
    330
    (242.8)
    -4
    (202.0)
    24. 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 ABC/DTG/3TC 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) + abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) (ABC/DTG/3TC) 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 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. 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 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.
    Measure Participants 205 204
    Mean (Standard Deviation) [cell/µL]
    339
    (237.8)
    -15
    (188.1)

    Adverse Events

    Time Frame Adverse Events: First dose date up to last dose date (maximum: 279 weeks) plus 30 days All-Cause Mortality: Randomization date through last visit/follow up date (maximum duration: 282.4 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 ABC/DTG/3TC B/F/TAF to B/F/TAF ABC/DTG/3TC to B/F/TAF
    Arm/Group Description B/F/TAF (50/200/25 mg) FDC tablet + ABC/DTG/3TC placebo orally once daily for at least 144 weeks, without regard to food. ABC/DTG/3TC (600/50/300 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 attend 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 ABC/DTG/3TC B/F/TAF to B/F/TAF ABC/DTG/3TC to B/F/TAF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/316 (0.6%) 1/315 (0.3%) 2/252 (0.8%) 2/254 (0.8%)
    Serious Adverse Events
    B/F/TAF ABC/DTG/3TC B/F/TAF to B/F/TAF ABC/DTG/3TC to B/F/TAF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 44/314 (14%) 54/315 (17.1%) 19/252 (7.5%) 19/254 (7.5%)
    Blood and lymphatic system disorders
    Anaemia 2/314 (0.6%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Anaemia of chronic disease 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Febrile neutropenia 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Cardiac disorders
    Acute myocardial infarction 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Atrial fibrillation 1/314 (0.3%) 0/315 (0%) 1/252 (0.4%) 1/254 (0.4%)
    Cardiac failure acute 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 1/254 (0.4%)
    Myocardial infarction 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Ventricular tachycardia 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Ear and labyrinth disorders
    Middle ear adhesions 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Vertigo 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Endocrine disorders
    Goitre 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Eye disorders
    Blindness transient 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Gastrointestinal disorders
    Abdominal hernia 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Abdominal incarcerated hernia 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Abdominal pain 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 1/254 (0.4%)
    Constipation 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Diarrhoea 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 1/254 (0.4%)
    Gastric varices haemorrhage 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Gastrointestinal haemorrhage 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 1/254 (0.4%)
    Haematemesis 2/314 (0.6%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Haematochezia 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Haemorrhoids thrombosed 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Lower gastrointestinal haemorrhage 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Nausea 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Oesophageal food impaction 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Pancreatitis acute 1/314 (0.3%) 2/315 (0.6%) 0/252 (0%) 0/254 (0%)
    Small intestinal obstruction 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Steatorrhoea 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Upper gastrointestinal haemorrhage 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Vomiting 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    General disorders
    Chest discomfort 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Chest pain 2/314 (0.6%) 2/315 (0.6%) 0/252 (0%) 1/254 (0.4%)
    Death 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Drug withdrawal syndrome 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Pyrexia 1/314 (0.3%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Hepatobiliary disorders
    Cholecystitis 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Hepatic cytolysis 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Hepatitis acute 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Infections and infestations
    Abdominal wall abscess 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Abscess limb 2/314 (0.6%) 2/315 (0.6%) 0/252 (0%) 0/254 (0%)
    Anal abscess 0/314 (0%) 1/315 (0.3%) 1/252 (0.4%) 0/254 (0%)
    Appendicitis 3/314 (1%) 2/315 (0.6%) 0/252 (0%) 0/254 (0%)
    Appendicitis perforated 2/314 (0.6%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Bacteraemia 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Breast abscess 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Bronchitis 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Cellulitis 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 2/254 (0.8%)
    Complicated appendicitis 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Covid-19 0/314 (0%) 0/315 (0%) 2/252 (0.8%) 0/254 (0%)
    Covid-19 pneumonia 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Diverticulitis 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Enterobacter sepsis 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Fungaemia 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Gastroenteritis 0/314 (0%) 2/315 (0.6%) 0/252 (0%) 0/254 (0%)
    Gastroenteritis viral 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Gonococcal infection 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Gonorrhoea 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Groin abscess 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Hepatitis A 0/314 (0%) 2/315 (0.6%) 0/252 (0%) 0/254 (0%)
    Influenza 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Injection site cellulitis 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Kidney infection 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Localised infection 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Mastoiditis 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Meningitis cryptococcal 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Mycobacterium avium complex infection 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Neurosyphilis 1/314 (0.3%) 2/315 (0.6%) 0/252 (0%) 0/254 (0%)
    Ophthalmic herpes zoster 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Orchitis 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Osteomyelitis 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 1/254 (0.4%)
    Perirectal abscess 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 1/254 (0.4%)
    Pharyngeal abscess 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Pneumonia 2/314 (0.6%) 1/315 (0.3%) 0/252 (0%) 1/254 (0.4%)
    Pneumonia bacterial 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Pneumonia legionella 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Pneumonia pneumococcal 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Sepsis 0/314 (0%) 2/315 (0.6%) 0/252 (0%) 0/254 (0%)
    Septic shock 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Soft tissue infection 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Tracheobronchitis 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Viral infection 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Wound infection 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Injury, poisoning and procedural complications
    Accidental overdose 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Acetabulum fracture 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Alcohol poisoning 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Femur fracture 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Fibula fracture 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Joint dislocation 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Limb injury 1/314 (0.3%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Lower limb fracture 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Overdose 2/314 (0.6%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Postoperative ileus 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Pulmonary contusion 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Road traffic accident 0/314 (0%) 3/315 (1%) 0/252 (0%) 1/254 (0.4%)
    Spinal fracture 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Stab wound 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Tibia fracture 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Toxicity to various agents 0/314 (0%) 2/315 (0.6%) 1/252 (0.4%) 0/254 (0%)
    Traumatic fracture 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Investigations
    Anticoagulation drug level above therapeutic 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Psychiatric evaluation 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    White blood cell count increased 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Metabolism and nutrition disorders
    Dehydration 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Diabetes mellitus inadequate control 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Diabetic ketoacidosis 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Hyperkalaemia 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Musculoskeletal and connective tissue disorders
    Gouty arthritis 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Intervertebral disc protrusion 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Muscular weakness 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Neck pain 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anaplastic large-cell lymphoma 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    High-grade B-cell lymphoma 0/314 (0%) 2/315 (0.6%) 0/252 (0%) 0/254 (0%)
    Hodgkin's disease 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Lipoma 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Prostate cancer 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Nervous system disorders
    Bell's palsy 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Generalised tonic-clonic seizure 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Headache 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Hypoaesthesia 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Ischaemic stroke 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Seizure 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 1/254 (0.4%)
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Psychiatric disorders
    Anxiety 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Bipolar I disorder 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Borderline personality disorder 1/314 (0.3%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Delirium tremens 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Depression 0/314 (0%) 2/315 (0.6%) 1/252 (0.4%) 0/254 (0%)
    Drug dependence 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Hallucination, tactile 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Intentional self-injury 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Major depression 3/314 (1%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Mental disorder 1/314 (0.3%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Psychotic disorder 1/314 (0.3%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Schizophrenia 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Suicidal ideation 3/314 (1%) 3/315 (1%) 1/252 (0.4%) 1/254 (0.4%)
    Suicide attempt 2/314 (0.6%) 1/315 (0.3%) 0/252 (0%) 1/254 (0.4%)
    Renal and urinary disorders
    Acute kidney injury 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 2/254 (0.8%)
    Chronic kidney disease 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Diabetic nephropathy 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    End stage renal disease 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Nephrolithiasis 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Renal failure 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Reproductive system and breast disorders
    Endometrial thickening 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Penile necrosis 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Testicular mass 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Testicular pain 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Uterine polyp 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 0/314 (0%) 0/315 (0%) 0/252 (0%) 1/254 (0.4%)
    Dyspnoea 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Nasal turbinate hypertrophy 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Pulmonary embolism 1/314 (0.3%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Pulmonary oedema 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Respiratory failure 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Social circumstances
    Alcohol use 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Surgical and medical procedures
    Abortion induced 0/314 (0%) 0/315 (0%) 1/252 (0.4%) 0/254 (0%)
    Vascular disorders
    Deep vein thrombosis 1/314 (0.3%) 0/315 (0%) 0/252 (0%) 0/254 (0%)
    Hypotension 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Peripheral arterial occlusive disease 0/314 (0%) 1/315 (0.3%) 0/252 (0%) 0/254 (0%)
    Other (Not Including Serious) Adverse Events
    B/F/TAF ABC/DTG/3TC B/F/TAF to B/F/TAF ABC/DTG/3TC to B/F/TAF
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 262/314 (83.4%) 276/315 (87.6%) 152/252 (60.3%) 153/254 (60.2%)
    Gastrointestinal disorders
    Abdominal pain 18/314 (5.7%) 23/315 (7.3%) 5/252 (2%) 6/254 (2.4%)
    Constipation 15/314 (4.8%) 17/315 (5.4%) 2/252 (0.8%) 6/254 (2.4%)
    Diarrhoea 54/314 (17.2%) 57/315 (18.1%) 6/252 (2.4%) 13/254 (5.1%)
    Nausea 40/314 (12.7%) 77/315 (24.4%) 8/252 (3.2%) 7/254 (2.8%)
    Vomiting 18/314 (5.7%) 24/315 (7.6%) 3/252 (1.2%) 7/254 (2.8%)
    General disorders
    Fatigue 35/314 (11.1%) 41/315 (13%) 7/252 (2.8%) 11/254 (4.3%)
    Pyrexia 15/314 (4.8%) 19/315 (6%) 8/252 (3.2%) 8/254 (3.1%)
    Immune system disorders
    Seasonal allergy 7/314 (2.2%) 16/315 (5.1%) 3/252 (1.2%) 5/254 (2%)
    Infections and infestations
    Anal chlamydia infection 16/314 (5.1%) 29/315 (9.2%) 6/252 (2.4%) 11/254 (4.3%)
    Bronchitis 20/314 (6.4%) 30/315 (9.5%) 3/252 (1.2%) 2/254 (0.8%)
    Chlamydial infection 23/314 (7.3%) 13/315 (4.1%) 8/252 (3.2%) 8/254 (3.1%)
    Covid-19 0/314 (0%) 0/315 (0%) 20/252 (7.9%) 23/254 (9.1%)
    Gastroenteritis 17/314 (5.4%) 21/315 (6.7%) 6/252 (2.4%) 8/254 (3.1%)
    Gonorrhoea 22/314 (7%) 21/315 (6.7%) 5/252 (2%) 5/254 (2%)
    Influenza 22/314 (7%) 16/315 (5.1%) 4/252 (1.6%) 9/254 (3.5%)
    Nasopharyngitis 41/314 (13.1%) 52/315 (16.5%) 18/252 (7.1%) 14/254 (5.5%)
    Pharyngitis 17/314 (5.4%) 23/315 (7.3%) 6/252 (2.4%) 5/254 (2%)
    Proctitis gonococcal 17/314 (5.4%) 21/315 (6.7%) 9/252 (3.6%) 13/254 (5.1%)
    Sinusitis 15/314 (4.8%) 23/315 (7.3%) 3/252 (1.2%) 4/254 (1.6%)
    Syphilis 43/314 (13.7%) 51/315 (16.2%) 22/252 (8.7%) 22/254 (8.7%)
    Upper respiratory tract infection 46/314 (14.6%) 61/315 (19.4%) 16/252 (6.3%) 19/254 (7.5%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 36/314 (11.5%) 41/315 (13%) 13/252 (5.2%) 12/254 (4.7%)
    Back pain 35/314 (11.1%) 43/315 (13.7%) 15/252 (6%) 15/254 (5.9%)
    Pain in extremity 18/314 (5.7%) 13/315 (4.1%) 9/252 (3.6%) 12/254 (4.7%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts 12/314 (3.8%) 19/315 (6%) 6/252 (2.4%) 3/254 (1.2%)
    Nervous system disorders
    Dizziness 10/314 (3.2%) 19/315 (6%) 2/252 (0.8%) 2/254 (0.8%)
    Headache 44/314 (14%) 56/315 (17.8%) 8/252 (3.2%) 9/254 (3.5%)
    Psychiatric disorders
    Anxiety 31/314 (9.9%) 21/315 (6.7%) 11/252 (4.4%) 12/254 (4.7%)
    Depression 19/314 (6.1%) 27/315 (8.6%) 4/252 (1.6%) 12/254 (4.7%)
    Insomnia 27/314 (8.6%) 35/315 (11.1%) 8/252 (3.2%) 5/254 (2%)
    Respiratory, thoracic and mediastinal disorders
    Cough 34/314 (10.8%) 22/315 (7%) 13/252 (5.2%) 9/254 (3.5%)
    Oropharyngeal pain 22/314 (7%) 35/315 (11.1%) 13/252 (5.2%) 6/254 (2.4%)
    Skin and subcutaneous tissue disorders
    Rash 30/314 (9.6%) 32/315 (10.2%) 10/252 (4%) 6/254 (2.4%)
    Vascular disorders
    Hypertension 24/314 (7.6%) 16/315 (5.1%) 8/252 (3.2%) 9/254 (3.5%)

    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:
    NCT02607930
    Other Study ID Numbers:
    • GS-US-380-1489
    • 2015-004024-54
    First Posted:
    Nov 18, 2015
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022