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    Clinical Trial Results:
    A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

    Summary
    EudraCT number
    		 2018-000926-79
    Trial protocol
    		 FR   ES   GR  
    Global end of trial date
    07 Mar 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2025
    First version publication date
    15 Mar 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-380-4458
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03547908
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Mar 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Feb 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Mar 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of fixed-dose combination (FDC) of bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF) versus dolutegravir (DTG) + emtricitabine/tenofovir disoproxil fumarate (F/TDF) in treatment-naïve and HIV-1 and hepatitis B virus (HBV) adults.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 May 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Dominican Republic: 10
    Country: Number of subjects enrolled
    Malaysia: 37
    Country: Number of subjects enrolled
    United States: 3
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Türkiye: 9
    Country: Number of subjects enrolled
    Hong Kong: 5
    Country: Number of subjects enrolled
    Puerto Rico: 1
    Country: Number of subjects enrolled
    Taiwan: 12
    Country: Number of subjects enrolled
    China: 56
    Country: Number of subjects enrolled
    Japan: 8
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    Thailand: 94
    Worldwide total number of subjects
    244
    EEA total number of subjects
    7
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    242
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the North American, Asian and European regions.

    Pre-assignment
    Screening details
    		 381 participants were screened.

    Period 1
    Period 1 title
    Blinded Phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Blinded Phase: B/F/TAF
    Arm description
    		 Participants who were HIV-1 and HBV co-infected and treatment-naïve received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    B/F/TAF
    Investigational medicinal product code
    Other name
    Biktarvy®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50/200/25 mg fixed-dose combination (FDC) tablet administered once daily, without regard to food.

    Investigational medicinal product name
    Placebo to Match F/TDF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily, without regard to food.

    Investigational medicinal product name
    Placebo to Match DTG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily, without regard to food.

    Arm title
    		 Blinded Phase: DTG + F/TDF
    Arm description
    		 Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    DTG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily, without regard to food.

    Investigational medicinal product name
    Placebo to Match F/TDF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily, without regard to food.

    Investigational medicinal product name
    F/TDF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily, without regard to food.

    Number of subjects in period 1 [1]
    		Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Started
    121
    122
    Completed
    111
    113
    Not completed
    10
    9
         Withdrew Consent
    2
    3
         Adverse Event
    1
    -
         Death
    2
    -
         Investigator’s Discretion
    2
    1
         Non-Compliance With Study Drug
    -
    2
         Lost to follow-up
    3
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One participant was randomized to B/f/TAF group but was not treated.
    Period 2
    Period 2 title
    Open-label Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Open-Label Extension Phase: B/F/TAF from B/F/TAF
    Arm description
    		 After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive 48-weeks of open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    B/F/TAF
    Investigational medicinal product code
    Other name
    Biktarvy®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50/200/25 mg B/F/TAF FDC tablet administered once daily, without regard to food.

    Arm title
    		 Open-Label Extension Phase: B/F/TAF from DTG+F/TDF
    Arm description
    		 After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive 48-weeks of open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    B/F/TAF
    Investigational medicinal product code
    Other name
    Biktarvy®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50/200/25 mg B/F/TAF FDC tablet administered once daily, without regard to food.

    Number of subjects in period 2 [2]
    		Open-Label Extension Phase: B/F/TAF from B/F/TAF Open-Label Extension Phase: B/F/TAF from DTG+F/TDF
    Started
    95
    89
    Completed
    91
    88
    Not completed
    4
    1
         Death
    1
    -
         Lost to follow-up
    3
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Out of 111 (B/F/TAF) and 113 (DTG + F/TDF) participants who completed the Blinded Phase, 95 participants from B/F/TAF and 89 participants from DTG + F/TDF entered the Open-label Extension Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Blinded Phase: B/F/TAF
    Reporting group description
    		 Participants who were HIV-1 and HBV co-infected and treatment-naïve received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.

    Reporting group title
    Blinded Phase: DTG + F/TDF
    Reporting group description
    		 Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.

    Reporting group values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF Total
    Number of subjects
    		 121 122 243
    Age categorical
    Units: Subjects
        Between 18 and 65 years
    		 120 121 241
        >=65 years
    		 1 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 ( ) ( ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 2 11
        Male
    		 112 120 232
    Race
    Units: Subjects
        Asian
    		 108 106 214
        White
    		 10 9 19
        Black
    		 2 6 8
        Other
    		 1 1 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 7 10 17
        Not Hispanic or Latino
    		 114 112 226
    CD4 Percentage
    Units: percentage of CD4 cells
        arithmetic mean (standard deviation)
    		 ( ) 14.8 ( 8.25 ) -
    CD4 Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    		 ( ) 266 ( 194.3 ) -
    Subject analysis sets

    Subject analysis set title
    Blinded Phase: B/F/TAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who were HIV-1 and HBV coinfected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.

    Subject analysis sets values
    		 Blinded Phase: B/F/TAF
    Number of subjects
    121
    Age categorical
    Units: Subjects
        Between 18 and 65 years
        >=65 years
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    33 ( 9.2 )
    Gender categorical
    Units: Subjects
        Female
        Male
    Race
    Units: Subjects
        Asian
        White
        Black
        Other
    Ethnicity
    Units: Subjects
        Hispanic or Latino
        Not Hispanic or Latino
    CD4 Percentage
    Units: percentage of CD4 cells
        arithmetic mean (standard deviation)
    16.0 ( 8.62 )
    CD4 Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    282 ( 193.1 )

    End points

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    End points reporting groups
    Reporting group title
    Blinded Phase: B/F/TAF
    Reporting group description
    		 Participants who were HIV-1 and HBV co-infected and treatment-naïve received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.

    Reporting group title
    Blinded Phase: DTG + F/TDF
    Reporting group description
    		 Participants who were HIV-1 and HBV co-infected and treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants also received PTM B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.
    Reporting group title
    Open-Label Extension Phase: B/F/TAF from B/F/TAF
    Reporting group description
    		 After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive 48-weeks of open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.

    Reporting group title
    Open-Label Extension Phase: B/F/TAF from DTG+F/TDF
    Reporting group description
    		 After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive 48-weeks of open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.

    Subject analysis set title
    Blinded Phase: B/F/TAF
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Participants who were HIV-1 and HBV coinfected and treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants also received placebo to match (PTM) dolutegravir (DTG) tablet and PTM emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.

    Primary: Percentage of Participants With Plasma Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach (Co-primary Endpoint)

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    End point title
    		 Percentage of Participants With Plasma Hepatitis B Virus (HBV) DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach (Co-primary Endpoint)
    End point description
    This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Participants in the Full Analysis Set were analyzed.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    119
    122
    Units: percentage of participants
        number (not applicable)
    63.0
    43.4
    Statistical analysis title
    		 Plasma Hepatitis B Virus (HBV) DNA < 29 IU/mL
    Statistical analysis description
    A sample size of 240 participants provided 81% power to detect a non-inferiority margin of 12% between the 2 treatment groups. This assumed that both treatment groups have a response rate of 88% (based on Gilead Studies GS-US-320-0108 and GS-US-320-0110), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.
    Comparison groups
    Blinded Phase: DTG + F/TDF v Blinded Phase: B/F/TAF
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    16.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.9
         upper limit
    		 27.3
    Notes
    [1] - The difference in percentages of participants with HBV DNA < 29 IU/mL between treatment groups and its 95.001% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).
    Statistical analysis title
    		 Plasma Hepatitis B Virus (HBV) DNA < 29 IU/mL
    Comparison groups
    Blinded Phase: DTG + F/TDF v Blinded Phase: B/F/TAF
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0023 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - The p-value was from CMH test stratified by baseline HBeAg status (positive vs negative) and HBV DNA category (< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).

    Primary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm (Co-primary Endpoint)

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm (Co-primary Endpoint)
    End point 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. Percentages were rounded off. The Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had at least 1 postbaseline HIV-1 RNA or HBV DNA result while on study drug.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    119
    122
    Units: percentage of participants
        number (not applicable)
    95.0
    91.0
    Statistical analysis title
    		 HIV-1 RNA < 50 Copies/mL at Week 48
    Statistical analysis description
    The difference in percentages of participants between groups and their 95.001% confidence intervals (CI)s were calculated based on Mantel-Haenszel (MH) proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL).
    Comparison groups
    Blinded Phase: DTG + F/TDF v Blinded Phase: B/F/TAF
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 10.8
    Notes
    [3] - A sample size of 240 participants randomized in a 1:1 ratio to 2 treatment groups, achieved 90% power to detect a non-inferiority margin of 12% between the 2 treatment groups. For the sample size and power computation, it is assumed that both treatment groups have a response rate of 91% (based on Gilead Studies GS-US-380-1489 and GS-US-380-1490), that the non-inferiority margin is 12%, and that the significance level of the test is at a one-sided 0.025 level.
    Statistical analysis title
    		 HIV-1 RNA < 50 Copies/mL at Week 48
    Comparison groups
    Blinded Phase: DTG + F/TDF v Blinded Phase: B/F/TAF
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2113 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [4] - The p-value was calculated from Cochran-Mantel-Haenszel (CMH) test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL).

    Secondary: Change from Baseline in CD4 Cell Count at Week 48

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    End point title
    		 Change from Baseline in CD4 Cell Count at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    117
    116
    Units: cells/µL
        arithmetic mean (standard deviation)
    200 ( 139.3 )
    175 ( 124.7 )
    Statistical analysis title
    		 Change from Baseline in CD4 Cell Count at Week 48
    Comparison groups
    Blinded Phase: DTG + F/TDF v Blinded Phase: B/F/TAF
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.1701 [6]
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares mean (LSM)
    Point estimate
    24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10
         upper limit
    		 58
    Notes
    [5] - The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL).
    [6] - The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL).

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
    End point description
    The percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which was defined as 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. Percentages were rounded off. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    119
    122
    Units: percentage of participants
        number (not applicable)
    87.4
    87.7
    Statistical analysis title
    		 HIV-1 RNA < 50 Copies/mL at Week 96
    Comparison groups
    Blinded Phase: B/F/TAF v Blinded Phase: DTG + F/TDF
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.9427 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.9
         upper limit
    		 8.3
    Notes
    [7] - The difference in percentages of participants with HIV-1 RNA < 50 copies/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
    [8] - P-value for the superiority test comparing the percentages of participants with HIV-1 RNA < 50 copies/mL between treatment groups was from the CMH test stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).

    Secondary: Change from Baseline in CD4 Percentage at Week 48

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    End point title
    		 Change from Baseline in CD4 Percentage at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    117
    116
    Units: percentage of CD4 cells
        arithmetic mean (standard deviation)
    8.43 ( 4.1 )
    7.75 ( 4.3 )
    Statistical analysis title
    		 Change from Baseline in CD4 Percentage at Week 48
    Comparison groups
    Blinded Phase: DTG + F/TDF v Blinded Phase: B/F/TAF
    Number of subjects included in analysis
    233
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.2839 [10]
    Method
    		 ANOVA
    Parameter type
    		 Difference in least squares mean (LSM)
    Point estimate
    0.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.49
         upper limit
    		 1.67
    Notes
    [9] - The difference in least squares means and its 95% CI were calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL).
    [10] - The p-value was calculated using ANOVA model adjusted by the baseline HIV-1 RNA stratum (≤ 100,000 vs. > 100,000 copies/mL).

    Secondary: Change from Baseline in CD4 Cell Count at Week 96

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    End point title
    		 Change from Baseline in CD4 Cell Count at Week 96
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 96
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    109
    113
    Units: cells/uL
        arithmetic mean (standard deviation)
    261 ( 161.6 )
    229 ( 174.0 )
    Statistical analysis title
    		 Change From Baseline in CD4 Cell Count at Week 96
    Statistical analysis description
    Difference in least squares means (Diff in LSM) and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
    Comparison groups
    Blinded Phase: B/F/TAF v Blinded Phase: DTG + F/TDF
    Number of subjects included in analysis
    222
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1853 [11]
    Method
    		 ANOVA
    Parameter type
    		 Difference in Least Squares Means
    Point estimate
    30
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14
         upper limit
    		 74
    Notes
    [11] - P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).

    Secondary: Percentage of Participants With Plasma HBV DNA < 29 IU/mL at Week 96

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    End point title
    		 Percentage of Participants With Plasma HBV DNA < 29 IU/mL at Week 96
    End point description
    This outcome measure was analyzed using a Missing = Failure approach. In this approach, all missing data were treated as HBV DNA ≥ 29 IU/mL. Percentages were rounded-off. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    119
    122
    Units: percentage of participants
        number (not applicable)
    74.8
    70.5
    Statistical analysis title
    		 Plasma HBV DNA < 29 IU/mL at Week 96
    Comparison groups
    Blinded Phase: B/F/TAF v Blinded Phase: DTG + F/TDF
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 = 0.6367 [13]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.3
         upper limit
    		 13.4
    Notes
    [12] - The difference in percentages of participants with HBV DNA < 29 IU/mL between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).
    [13] - P value for the superiority test comparing the percentages of participants with HBV DNA < 29 IU/mL between treatment groups was from CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA category (< 8 log10 IU/mL).

    Secondary: Change from Baseline in CD4 Percentage at Week 96

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    End point title
    		 Change from Baseline in CD4 Percentage at Week 96
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 96
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    108
    112
    Units: percentage of CD4 cells
        arithmetic mean (standard deviation)
    10.69 ( 5.047 )
    10.42 ( 5.096 )
    Statistical analysis title
    		 Change From Baseline in CD4 Percentage at Week 96
    Statistical analysis description
    Difference in LSM and its 95% CI were from ANOVA model adjusted by the baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
    Comparison groups
    Blinded Phase: B/F/TAF v Blinded Phase: DTG + F/TDF
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8456 [14]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 1.46
    Notes
    [14] - P-value was from ANOVA model adjusted by the baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).

    Secondary: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 by American Association for the Study of Liver Diseases (AASLD) Criteria

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    End point title
    		 Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 by American Association for the Study of Liver Diseases (AASLD) Criteria
    End point description
    ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis. Percentages were rounded off. Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    60
    47
    Units: percentage of participants
        number (not applicable)
    73.3
    55.3
    Statistical analysis title
    		 ALT Normalization at Week 48
    Comparison groups
    Blinded Phase: DTG + F/TDF v Blinded Phase: B/F/TAF
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    P-value
    		 = 0.0655 [16]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    17.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.5
         upper limit
    		 35.7
    Notes
    [15] - The difference in percentages of participants between groups and their 95% CIs were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).
    [16] - P-value was calculated from CMH tests stratified by baseline HBeAg status (positive vs negative) and HBV DNA (< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).

    Secondary: Percentage of Participants With ALT Normalization at Week 96

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    End point title
    		 Percentage of Participants With ALT Normalization at Week 96
    End point description
    ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given post baseline visit. The upper limit of the normal range (ULN) for ALT using the 2018 AASLD normal range was ≤ 25 U/L for females and ≤ 35 U/L for males. The Missing = Failure approach was used for this analysis. Percentages were rounded-off. Participants in the Full Analysis Set with Baseline ALT > ULN were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    60
    47
    Units: percentage of participants
        number (not applicable)
    71.7
    57.4
    Statistical analysis title
    		 ALT Normalization at Week 96
    Comparison groups
    Blinded Phase: B/F/TAF v Blinded Phase: DTG + F/TDF
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 = 0.1253 [18]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    14.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 32.6
    Notes
    [17] - Difference in the proportion between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (< 8 log10 IU/mL vs >= 8 log10 IU/mL).
    [18] - P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (< 8 log10 IU/mL vs >= 8 log10 IU/mL).

    Secondary: Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48

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    End point title
    		 Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48
    End point description
    HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis. Percentages were rounded-off. The Serologically Evaluable Full Analysis Set for HBsAg loss/seroconversion included all participants who were in the Full Analysis Set and with HBsAg positive and HBsAb negative or missing at baseline.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    119
    121
    Units: percentage of participants
        number (not applicable)
    12.6
    5.8
    Statistical analysis title
    		 Hepatitis B Surface Antigen (HBsAg) Loss
    Comparison groups
    Blinded Phase: DTG + F/TDF v Blinded Phase: B/F/TAF
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    P-value
    		 = 0.0591 [20]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    7.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.8
         upper limit
    		 15
    Notes
    [19] - Difference in the percentages between treatment groups and its 95% CI were calculated based on the MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).
    [20] - P-value was from the CMH tests stratified by baseline HBeAg status (positive vs negative)and baseline HBV DNA (< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).

    Secondary: Percentage of Participants With HBsAg Loss at Week 96

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    End point title
    		 Percentage of Participants With HBsAg Loss at Week 96
    End point description
    HBsAg loss was defined as qualitative HBsAg changing from positive at baseline to negative at a post baseline visit. HBsAg seroconversion was defined as HBsAg loss and HBsAb changes from negative or missing at baseline to positive at a post baseline visit. The Missing = Failure approach was used for this analysis. Percentages were rounded-off. Participants in the Serologically Evaluable Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Blinded Phase: B/F/TAF Blinded Phase: DTG + F/TDF
    Number of subjects analysed
    119
    121
    Units: percentage of participants
        number (not applicable)
    22.7
    14.0
    Statistical analysis title
    		 HBsAg Loss at Week 96
    Comparison groups
    Blinded Phase: B/F/TAF v Blinded Phase: DTG + F/TDF
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    P-value
    		 = 0.0655 [22]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    9.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 19.2
    Notes
    [21] - Differences in percentages between treatment groups and their 95% CI were calculated based on MH proportions adjusted by baseline HBeAg status (positive vs negative) and baseline HBV DNA (< 8 log10 IU/mL vs ≥ 8 log10 IU/mL).
    [22] - P value was from the CMH test stratified by baseline HBeAg status (positive vs negative) and baseline HBV DNA (< 8 log10 IU/mL vs ≥ 8 log10 IU/mL). Statistically significant values are shown in bold.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events: Up to the last dose date plus 30 days (maximum exposure: 5.1 years); All-Cause Mortality: Up to 5.3 years
    Adverse event reporting additional description
    All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse Events: The Safely Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Blinded B/F/TAF
    Reporting group description
    		 Participants who were HIV-1 and HBV coinfected treatment-naïve received Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) fixed-dose combination (FDC) tablet orally, once daily without regard to food for 96 weeks. Participants received placebo to match (PTM) dolutegravir (DTG) tablet and PTM emtricitabine/ tenofovir desoproxil fumarate (F/TDF) tablet orally once daily without regard to food for 96 weeks.

    Reporting group title
    OL B/F/TAF from DTG + F/TDF
    Reporting group description
    		 After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.

    Reporting group title
    OL B/F/TAF from B/F/TAF
    Reporting group description
    		 After Week 96, participants continued their blinded study drug and attended visits every 12 weeks until the End of Blinded Treatment Visit. Following the End of Blinded Treatment Visit, if safety and efficacy of B/F/TAF FDC was demonstrated for the HIV-1 and HBV coinfected participants, in a country where B/F/TAF FDC was not available, participants were given the option to receive open-label B/F/TAF until the product became accessible through an access program, or until Gilead elected to discontinue the study in that country, whichever occurred first.

    Reporting group title
    Blinded DTG + F/TDF
    Reporting group description
    		 Participants who were HIV-1 and HBV coinfected treatment-naïve received DTG (50 mg) tablet + F/TDF (200/300 mg) FDC tablet, orally, once daily without regard to food for 96 weeks. Participants received PTM B/F/TAF tablet, orally, once daily without regard to food for 96 weeks.

    Serious adverse events
    		 Blinded B/F/TAF OL B/F/TAF from DTG + F/TDF OL B/F/TAF from B/F/TAF Blinded DTG + F/TDF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 121 (14.05%)
    2 / 89 (2.25%)
    4 / 95 (4.21%)
    16 / 122 (13.11%)
         number of deaths (all causes)
    2
    0
    1
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Sinonasal papilloma
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glottis carcinoma
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial ischaemia
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Alcoholic seizure
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 89 (1.12%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death, not otherwise specified
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    Influenza like illness
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Rhegmatogenous retinal detachment
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    1 / 95 (1.05%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    2 / 95 (2.11%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar hernia
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermal cyst
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    1 / 95 (1.05%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial sepsis
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 89 (1.12%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    1 / 95 (1.05%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    3 / 121 (2.48%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    6 / 122 (4.92%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cytomegalovirus chorioretinitis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue haemorrhagic fever
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mycotoxicosis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 89 (1.12%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 121 (0.00%)
    1 / 89 (1.12%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis cryptococcal
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    0 / 122 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatic amoebiasis
         subjects affected / exposed
    0 / 121 (0.00%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    1 / 122 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Blinded B/F/TAF OL B/F/TAF from DTG + F/TDF OL B/F/TAF from B/F/TAF Blinded DTG + F/TDF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    102 / 121 (84.30%)
    40 / 89 (44.94%)
    42 / 95 (44.21%)
    98 / 122 (80.33%)
    Investigations
    Weight increased
         subjects affected / exposed
    13 / 121 (10.74%)
    6 / 89 (6.74%)
    6 / 95 (6.32%)
    12 / 122 (9.84%)
         occurrences all number
    17
    7
    6
    14
    Alanine aminotransferase increased
         subjects affected / exposed
    12 / 121 (9.92%)
    3 / 89 (3.37%)
    1 / 95 (1.05%)
    15 / 122 (12.30%)
         occurrences all number
    13
    3
    1
    19
    Aspartate aminotransferase increased
         subjects affected / exposed
    7 / 121 (5.79%)
    1 / 89 (1.12%)
    1 / 95 (1.05%)
    10 / 122 (8.20%)
         occurrences all number
    7
    1
    1
    11
    Injury, poisoning and procedural complications
    Vaccination complication
         subjects affected / exposed
    5 / 121 (4.13%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    7 / 122 (5.74%)
         occurrences all number
    5
    0
    0
    7
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 121 (6.61%)
    0 / 89 (0.00%)
    3 / 95 (3.16%)
    4 / 122 (3.28%)
         occurrences all number
    9
    0
    3
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 121 (4.13%)
    1 / 89 (1.12%)
    1 / 95 (1.05%)
    10 / 122 (8.20%)
         occurrences all number
    5
    1
    1
    12
    Headache
         subjects affected / exposed
    13 / 121 (10.74%)
    0 / 89 (0.00%)
    1 / 95 (1.05%)
    9 / 122 (7.38%)
         occurrences all number
    22
    0
    1
    9
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    7 / 121 (5.79%)
    1 / 89 (1.12%)
    1 / 95 (1.05%)
    2 / 122 (1.64%)
         occurrences all number
    7
    1
    1
    3
    Pyrexia
         subjects affected / exposed
    17 / 121 (14.05%)
    3 / 89 (3.37%)
    1 / 95 (1.05%)
    16 / 122 (13.11%)
         occurrences all number
    26
    3
    1
    23
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    8 / 121 (6.61%)
    1 / 89 (1.12%)
    0 / 95 (0.00%)
    2 / 122 (1.64%)
         occurrences all number
    8
    1
    0
    2
    Diarrhoea
         subjects affected / exposed
    13 / 121 (10.74%)
    6 / 89 (6.74%)
    2 / 95 (2.11%)
    11 / 122 (9.02%)
         occurrences all number
    15
    7
    2
    11
    Haemorrhoids
         subjects affected / exposed
    7 / 121 (5.79%)
    0 / 89 (0.00%)
    1 / 95 (1.05%)
    2 / 122 (1.64%)
         occurrences all number
    7
    0
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 121 (4.13%)
    1 / 89 (1.12%)
    1 / 95 (1.05%)
    8 / 122 (6.56%)
         occurrences all number
    5
    1
    1
    8
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    10 / 121 (8.26%)
    0 / 89 (0.00%)
    2 / 95 (2.11%)
    9 / 122 (7.38%)
         occurrences all number
    11
    0
    2
    9
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 121 (3.31%)
    0 / 89 (0.00%)
    1 / 95 (1.05%)
    9 / 122 (7.38%)
         occurrences all number
    4
    0
    1
    11
    Infections and infestations
    Folliculitis
         subjects affected / exposed
    1 / 121 (0.83%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    7 / 122 (5.74%)
         occurrences all number
    1
    0
    0
    8
    Syphilis
         subjects affected / exposed
    8 / 121 (6.61%)
    1 / 89 (1.12%)
    2 / 95 (2.11%)
    11 / 122 (9.02%)
         occurrences all number
    9
    1
    2
    12
    Nasopharyngitis
         subjects affected / exposed
    18 / 121 (14.88%)
    5 / 89 (5.62%)
    7 / 95 (7.37%)
    10 / 122 (8.20%)
         occurrences all number
    25
    7
    10
    14
    Upper respiratory tract infection
         subjects affected / exposed
    22 / 121 (18.18%)
    7 / 89 (7.87%)
    7 / 95 (7.37%)
    20 / 122 (16.39%)
         occurrences all number
    30
    8
    7
    26
    Covid-19
         subjects affected / exposed
    48 / 121 (39.67%)
    4 / 89 (4.49%)
    5 / 95 (5.26%)
    52 / 122 (42.62%)
         occurrences all number
    56
    4
    5
    60
    Latent syphilis
         subjects affected / exposed
    7 / 121 (5.79%)
    1 / 89 (1.12%)
    5 / 95 (5.26%)
    6 / 122 (4.92%)
         occurrences all number
    8
    1
    5
    6
    Secondary syphilis
         subjects affected / exposed
    7 / 121 (5.79%)
    1 / 89 (1.12%)
    1 / 95 (1.05%)
    7 / 122 (5.74%)
         occurrences all number
    8
    1
    1
    9
    Acute hepatitis C
         subjects affected / exposed
    9 / 121 (7.44%)
    0 / 89 (0.00%)
    0 / 95 (0.00%)
    2 / 122 (1.64%)
         occurrences all number
    9
    0
    0
    2
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    5 / 121 (4.13%)
    5 / 89 (5.62%)
    3 / 95 (3.16%)
    6 / 122 (4.92%)
         occurrences all number
    10
    5
    4
    9
    Abnormal weight gain
         subjects affected / exposed
    4 / 121 (3.31%)
    5 / 89 (5.62%)
    3 / 95 (3.16%)
    3 / 122 (2.46%)
         occurrences all number
    5
    7
    4
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Apr 2018
    Herein is a summary of the major changes made to the original protocol dated 02 March 2018 and reflected in Amendment 1 dated 10 April 2018 - Revised to include updates from ongoing bictegravir studies - Updated to include additional information in Risk/Benefit Assessment section - Update made to Biomarker Testing and Urine Samples testing - Revised to provide clarification to Management of HIV-1 Virologic Rebound - Revised to provide clarification to HBV Resistance Surveillance section Specific changes contained in Amendment 1 are presented herein. New text is indicated by bold/italics. Study synopsis, glossary, Appendix 2 Study Procedures Table and all applicable sections are updated to align with above mentioned changes in the protocol. In addition, the opportunity is taken to correct the administrative, typographical or grammatical errors.
    06 Jul 2018
    Herein is a summary of the major changes made to Protocol Amendment 1 dated 10 April 2018 and reflected in Protocol Amendment 2 dated 06 July 2018. In response to FDA’s Drug Safety Communication issued on May 18, 2018 for a serious finding of neural tube defect (NTD) changes have been made to the protocol sections outlined below.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37494942
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