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    Clinical Trial Results:
    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

    Summary
    EudraCT number
    		 2015-004024-54
    Trial protocol
    		 GB   BE   DE   ES   FR   IT  
    Global end of trial date
    02 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Mar 2022
    First version publication date
    23 Mar 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-380-1489
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02607930
    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
    02 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was 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 human immunodeficiency virus type 1 (HIV-1) infected, antiretroviral treatment naive-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
    13 Nov 2015
    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
    Belgium: 6
    Country: Number of subjects enrolled
    Canada: 33
    Country: Number of subjects enrolled
    Dominican Republic: 3
    Country: Number of subjects enrolled
    France: 21
    Country: Number of subjects enrolled
    Germany: 13
    Country: Number of subjects enrolled
    Italy: 18
    Country: Number of subjects enrolled
    Spain: 43
    Country: Number of subjects enrolled
    United Kingdom: 31
    Country: Number of subjects enrolled
    United States: 463
    Worldwide total number of subjects
    631
    EEA total number of subjects
    101
    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)
    627
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    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
    Screening details
    		 739 participants were screened.

    Period 1
    Period 1 title
    Double-Blinded Treatment 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
    		 B/F/TAF
    Arm 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABC/DTG/3TC Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily

    Investigational medicinal product name
    B/F/TAF
    Investigational medicinal product code
    Other name
    GS-9883/F/TAF
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50/200/25 mg FDC administered once daily

    Arm title
    		 ABC/DTG/3TC
    Arm description
    		 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.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    B/F/TAF Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily

    Investigational medicinal product name
    ABC/DTG/3TC
    Investigational medicinal product code
    Other name
    Triumeq®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600/50/300 mg FDC administered once daily

    Number of subjects in period 1 [1]
    		B/F/TAF ABC/DTG/3TC
    Started
    314
    315
    Completed
    262
    262
    Not completed
    52
    53
         Protocol violation
    2
    3
         Death
    2
    1
         Non-compliance with study drug
    3
    5
         Adverse event
    -
    4
         Lost to follow-up
    25
    19
         Withdrew consent
    14
    18
         Investigator's discretion
    6
    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: Two participants in B/F/TAF arm were randomized but was not treated.
    Period 2
    Period 2 title
    Open-Label B/F/TAF Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 B/F/TAF to B/F/TAF
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    B/F/TAF
    Investigational medicinal product code
    Other name
    GS-9883/F/TAF
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50/200/25 mg FDC administered once daily

    Arm title
    		 ABC/DTG/3TC to B/F/TAF
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    B/F/TAF
    Investigational medicinal product code
    Other name
    GS-9883/F/TAF
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50/200/25 mg FDC administered once daily

    Number of subjects in period 2 [2]
    		B/F/TAF to B/F/TAF ABC/DTG/3TC to B/F/TAF
    Started
    252
    254
    Completed
    218
    221
    Not completed
    34
    33
         Protocol violation
    1
    1
         Death
    -
    1
         Adverse event
    4
    2
         Non-compliance with study drug
    1
    -
         Lost to follow-up
    15
    10
         Withdrew consent
    10
    13
         Investigator's discretion
    2
    5
         Lack of efficacy
    1
    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: 10 participants from B/F/TAF arm did not enter the Open-Label Extension Phase. 8 participants from ABC/DTG/3TC arm did not enter the Open-Label Extension Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    B/F/TAF
    Reporting 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.

    Reporting group title
    ABC/DTG/3TC
    Reporting group description
    		 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.

    Reporting group values
    		 B/F/TAF ABC/DTG/3TC Total
    Number of subjects
    		 314 315 629
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34 ± 10.9 34 ± 10.8 -
    Gender categorical
    Units: Subjects
        Female
    		 29 33 62
        Male
    		 285 282 567
    Race
    Not Permitted = Local regulators did not allow collection of race.
    Units: Subjects
        American Indian or Alaska Native
    		 2 4 6
        Asian
    		 6 10 16
        Black
    		 114 112 226
        Native Hawaiian or Pacific Islander
    		 1 2 3
        White
    		 180 179 359
        Other
    		 9 8 17
        Not Permitted
    		 2 0 2
    Ethnicity
    Not Permitted = Local regulators did not allow collection of ethnicity.
    Units: Subjects
        Hispanic or Latino
    		 72 65 137
        Not Hispanic or Latino
    		 240 249 489
        Not Permitted
    		 2 1 3
    HIV-1 RNA Categories
    Units: Subjects
        ≤ 100,000 copies/mL
    		 261 265 526
        > 100,000 ≤ 400,000 copies/mL
    		 45 38 83
        > 400,000 copies/mL
    		 8 12 20
    CD4 Cell Count Categories
    Units: Subjects
        < 50 Cells/ μL
    		 7 10 17
        ≥ 50 to < 200 Cells/μL
    		 29 22 51
        ≥ 200 to < 350 Cells/μL
    		 69 58 127
        ≥ 350 to < 500 Cells/μL
    		 87 91 178
        ≥ 500 Cells/ μL
    		 122 134 256
    HIV-1 RNA
    Units: log10 copies/mL
        median (standard deviation)
    		 4.41 ± 0.647 4.42 ± 0.685 -
    CD4 Cell Count
    Units: Cells/μL
        arithmetic mean (standard deviation)
    		 453 ± 220.8 476 ± 231.4 -
    Hip Bone Mineral Density (BMD)
    Measure Analysis Population Description: The Hip Dual-energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had non-missing values for baseline hip BMD.
    Units: g/cm^2
        arithmetic mean (standard deviation)
    		 1.048 ± 0.1572 1.057 ± 0.1520 -
    Spine BMD
    Measure Analysis Population Description: The Spine DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and had nonmissing values for baseline spine BMD.
    Units: g/cm^2
        arithmetic mean (standard deviation)
    		 1.139 ± 0.1847 1.142 ± 0.1713 -

    End points

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    End points reporting groups
    Reporting group title
    B/F/TAF
    Reporting 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.

    Reporting group title
    ABC/DTG/3TC
    Reporting group description
    		 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.
    Reporting group title
    B/F/TAF to B/F/TAF
    Reporting group description
    		 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.

    Reporting group title
    ABC/DTG/3TC to B/F/TAF
    Reporting group description
    		 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.

    Subject analysis set title
    All B/F/TAF
    Subject analysis set type
    		 Full analysis
    Subject analysis set 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.

    Primary: Percentage of Participants who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 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 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. Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    314
    315
    Units: percentage of participants
        number (not applicable)
    92.4
    93.0
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Statistical analysis description
    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).
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 3.6
    Notes
    [1] - 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 analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.78 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - 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).

    Secondary: Percentage of Participants who Achieved 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 who Achieved 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 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. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    314
    315
    Units: percentage of participants
        number (not applicable)
    87.9
    89.8
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Statistical analysis description
    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).
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    -1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 3.1
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.45 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - 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).

    Secondary: Percentage of Participants who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants who Achieved HIV-1 RNA < 50 Copies/mL at Week 144 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 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. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 144
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    314
    315
    Units: percentage of participants
        number (not applicable)
    81.5
    84.1
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Statistical analysis description
    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).
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.5
         upper limit
    		 3.4
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.39 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [4] - 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).

    Secondary: Percentage of Participants who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants who Achieved HIV-1 RNA < 20 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
    End point 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. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    314
    315
    Units: percentage of participants
        number (not applicable)
    87.6
    87.3
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Statistical analysis description
    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).
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 5.6
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.87 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [5] - 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).

    Secondary: Percentage of Participants who Achieved HIV-1 RNA < 20 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants who Achieved HIV-1 RNA < 20 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 < 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. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    314
    315
    Units: percentage of participants
        number (not applicable)
    83.4
    84.8
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.9
         upper limit
    		 4.6
    Notes
    [6] - 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 title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.69 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [7] - 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).

    Secondary: Percentage of Participants who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants who Achieved HIV-1 RNA < 20 Copies/mL at Week 144 as Defined by the US FDA-Defined Snapshot Algorithm
    End point 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. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 144
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    314
    315
    Units: percentage of participants
        number (not applicable)
    78.0
    82.2
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Statistical analysis description
    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).
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.5
         upper limit
    		 2.1
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.19 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [8] - 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).

    Secondary: Change from Baseline in log10 HIV-1 RNA at Week 48

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    End point title
    		 Change from Baseline in log10 HIV-1 RNA 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
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    295
    302
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    -3.11 ± 0.641
    -3.07 ± 0.738
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Statistical analysis description
    Difference in least-squares mean (LSM), and its 95% confidence interval (CI) were adjusted by baseline HIV-1 RNA stratum and region stratum.
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    597
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.48 [9]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    -0.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.06
    Notes
    [9] - p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.

    Secondary: Change from Baseline in log10 HIV-1 RNA at Week 96

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    End point title
    		 Change from Baseline in log10 HIV-1 RNA 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
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    279
    288
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    -3.09 ± 0.643
    -3.10 ± 0.705
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Statistical analysis description
    Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    567
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.99
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.09
         upper limit
    		 0.09

    Secondary: Change from Baseline in log10 HIV-1 RNA at Week 144

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    End point title
    		 Change from Baseline in log10 HIV-1 RNA at Week 144
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 144
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    260
    269
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    -3.11 ± 0.639
    -3.10 ± 0.681
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Statistical analysis description
    Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    529
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.88
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    0.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.1

    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
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    294
    300
    Units: cells/µL
        arithmetic mean (standard deviation)
    235 ± 185.8
    228 ± 188.7
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Statistical analysis description
    Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    594
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.69 [10]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24
         upper limit
    		 36
    Notes
    [10] - P-value was adjusted by the baseline HIV-1 RNA and region stratum.

    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
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    276
    286
    Units: cells/µL
        arithmetic mean (standard deviation)
    287 ± 206.9
    288 ± 246.8
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Statistical analysis description
    Difference in LSM, and its 95% CI were adjusted by the baseline HIV-1 RNA and region stratum.
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    562
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.94 [11]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39
         upper limit
    		 36
    Notes
    [11] - P-value was adjusted by the baseline HIV-1 RNA and region stratum.

    Secondary: Change from Baseline in CD4+ Cell Count at Week 144

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    End point title
    		 Change from Baseline in CD4+ Cell Count at Week 144
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 144
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    255
    260
    Units: cells/µL
        arithmetic mean (standard deviation)
    299 ± 224.9
    317 ± 219.5
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Statistical analysis description
    Difference in LSM, and its 95% CI were adjusted by baseline HIV-1 RNA stratum and region stratum.
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    515
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3 [12]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    -20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -59
         upper limit
    		 18
    Notes
    [12] - p-value was adjusted by baseline HIV-1 RNA stratum and region stratum.

    Secondary: Percentage Change from Baseline in Hip BMD at Week 48

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    End point title
    		 Percentage Change from Baseline in Hip BMD at Week 48
    End point description
    Participants in the Hip DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    278
    281
    Units: percentage change
        arithmetic mean (standard deviation)
    -0.802 ± 2.3280
    -1.148 ± 2.5126
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    559
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.092
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    0.346
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.057
         upper limit
    		 0.748

    Secondary: Percentage Change from Baseline in Hip BMD at Week 96

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    End point title
    		 Percentage Change from Baseline in Hip BMD at Week 96
    End point description
    Participants in the Hip DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 96
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    250
    257
    Units: percentage change
        arithmetic mean (standard deviation)
    -1.128 ± 2.7702
    -1.262 ± 2.8524
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    507
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.59
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    0.135
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.356
         upper limit
    		 0.625

    Secondary: Percentage Change from Baseline in Hip BMD at Week 144

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    End point title
    		 Percentage Change from Baseline in Hip BMD at Week 144
    End point description
    Participants in the Hip DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 144
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    236
    240
    Units: percentage change
        arithmetic mean (standard deviation)
    -1.020 ± 3.7638
    -1.291 ± 3.1140
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    476
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.39
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    0.271
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.351
         upper limit
    		 0.893

    Secondary: Percentage Change from Baseline in Spine BMD at Week 48

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    End point title
    		 Percentage Change from Baseline in Spine BMD at Week 48
    End point description
    Participants in the Spine DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    284
    285
    Units: percentage change
        arithmetic mean (standard deviation)
    -0.772 ± 3.2228
    -0.552 ± 3.0956
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    569
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.41
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    -0.221
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.741
         upper limit
    		 0.3

    Secondary: Percentage Change from Baseline in Spine BMD at Week 96

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    End point title
    		 Percentage Change from Baseline in Spine BMD at Week 96
    End point description
    Participants in the Spine DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 96
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    256
    258
    Units: percentage change
        arithmetic mean (standard deviation)
    -0.705 ± 3.8721
    -0.219 ± 3.5159
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    514
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.14
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    -0.485
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.126
         upper limit
    		 0.155

    Secondary: Percentage Change from Baseline in Spine BMD at Week 144

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    End point title
    		 Percentage Change from Baseline in Spine BMD at Week 144
    End point description
    Participants in the Spine DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 144
    End point values
    		 B/F/TAF ABC/DTG/3TC
    Number of subjects analysed
    243
    244
    Units: percentage change
        arithmetic mean (standard deviation)
    -0.371 ± 4.4369
    0.035 ± 3.5182
    Statistical analysis title
    		 B/F/TAF, ABC/DTG/3TC
    Comparison groups
    B/F/TAF v ABC/DTG/3TC
    Number of subjects included in analysis
    487
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.26
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    -0.406
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.119
         upper limit
    		 0.307

    Secondary: Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded algorithm

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    End point title
    		 Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Excluded algorithm
    End point 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. 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.
    End point type
    Secondary
    End point timeframe
    Baseline, open-label Week 48
    End point values
    		 ABC/DTG/3TC to B/F/TAF All B/F/TAF
    Number of subjects analysed
    212
    237
    Units: percentage of participants
        number (confidence interval 95%)
    100 (98.3 to 100)
    99.2 (97.0 to 99.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm

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    End point title
    		 Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 48 Open-Label as Defined by Missing = Failure Algorithm
    End point 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. 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.
    End point type
    Secondary
    End point timeframe
    Baseline, open-label Week 48
    End point values
    		 ABC/DTG/3TC to B/F/TAF All B/F/TAF
    Number of subjects analysed
    254
    314
    Units: percentage of participants
        number (confidence interval 95%)
    83.5 (78.3 to 87.8)
    74.8 (69.7 to 79.5)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm

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    End point title
    		 Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Excluded Algorithm
    End point 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. 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 available participants at that time point from the Randomized Phase.
    End point type
    Secondary
    End point timeframe
    Baseline, open-label Week 96
    End point values
    		 ABC/DTG/3TC to B/F/TAF All B/F/TAF
    Number of subjects analysed
    218
    213
    Units: percentage of participants
        number (confidence interval 95%)
    99.5 (97.5 to 100)
    97.7 (94.6 to 99.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm

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    End point title
    		 Percentage of Participants Who Achieved HIV-1 RNA < 50 Copies/mL at Week 96 Open-Label as Defined by Missing = Failure Algorithm
    End point 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. 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.
    End point type
    Secondary
    End point timeframe
    Baseline, open-label Week 96
    End point values
    		 ABC/DTG/3TC to B/F/TAF All B/F/TAF
    Number of subjects analysed
    254
    314
    Units: percentage of participants
        number (confidence interval 95%)
    85.4 (80.5 to 89.5)
    66.2 (60.7 to 71.5)
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4+ Cell Count at Week 48 Open-Label

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    End point title
    		 Change From Baseline in CD4+ Cell Count at Week 48 Open-Label
    End point 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.
    End point type
    Secondary
    End point timeframe
    Baseline, open-label Week 48
    End point values
    		 ABC/DTG/3TC to B/F/TAF All B/F/TAF
    Number of subjects analysed
    212
    234
    Units: cells/μL
        arithmetic mean (standard deviation)
    -4 ± 202.0
    330 ± 242.8
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4+ Cell Count at Week 96 Open-Label

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    End point title
    		 Change From Baseline in CD4+ Cell Count at Week 96 Open-Label
    End point 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.
    End point type
    Secondary
    End point timeframe
    Baseline, open-label Week 96
    End point values
    		 ABC/DTG/3TC to B/F/TAF All B/F/TAF
    Number of subjects analysed
    204
    205
    Units: cell/μL
        arithmetic mean (standard deviation)
    -15 ± 188.1
    339 ± 237.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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 additional 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.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    B/F/TAF
    Reporting 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.

    Reporting group title
    ABC/DTG/3TC
    Reporting group description
    		 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.

    Reporting group title
    B/F/TAF to B/F/TAF
    Reporting group description
    		 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.

    Reporting group title
    ABC/DTG/3TC to B/F/TAF
    Reporting group description
    		 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.

    Serious adverse events
    		 B/F/TAF ABC/DTG/3TC B/F/TAF to B/F/TAF ABC/DTG/3TC to B/F/TAF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    44 / 314 (14.01%)
    54 / 315 (17.14%)
    19 / 252 (7.54%)
    19 / 254 (7.48%)
         number of deaths (all causes)
    2
    1
    2
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    High-grade B-cell lymphoma
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 315 (0.63%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaplastic large-cell lymphoma
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Hodgkin's disease
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Lipoma
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Prostate cancer
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Hypotension
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Peripheral arterial occlusive ~ disease
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Surgical and medical procedures
    Abortion induced
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 314 (0.64%)
    2 / 315 (0.63%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Death
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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 / 1
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Social circumstances
    Alcohol use
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Reproductive system and breast disorders
    Endometrial thickening
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Penile necrosis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Testicular mass
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Testicular pain
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Uterine polyp
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Dyspnoea
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Nasal turbinate hypertrophy
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Pulmonary oedema
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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 / 1
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    3 / 314 (0.96%)
    3 / 315 (0.95%)
    1 / 252 (0.40%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    2 / 314 (0.64%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 315 (0.63%)
    1 / 252 (0.40%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    3 / 314 (0.96%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Borderline personality disorder
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Psychotic disorder
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Bipolar I disorder
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Delirium tremens
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Drug dependence
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Hallucination, tactile
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Intentional self-injury
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Schizophrenia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Investigations
    Anticoagulation drug level above ~ therapeutic
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Psychiatric evaluation
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    White blood cell count increased
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 314 (0.00%)
    3 / 315 (0.95%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 315 (0.63%)
    1 / 252 (0.40%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 314 (0.32%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    2 / 314 (0.64%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Acetabulum fracture
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Alcohol poisoning
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Femur fracture
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Fibula fracture
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Joint dislocation
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Lower limb fracture
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Postoperative ileus
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Pulmonary contusion
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Spinal fracture
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Stab wound
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Tibia fracture
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Traumatic fracture
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Atrial fibrillation
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Myocardial infarction
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Ventricular tachycardia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Bell's palsy
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Headache
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Hypoaesthesia
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Ischaemic stroke
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 314 (0.64%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaemia of chronic disease
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Febrile neutropenia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Ear and labyrinth disorders
    Middle ear adhesions
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Vertigo
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Blindness transient
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Gastrointestinal disorders
    Pancreatitis acute
         subjects affected / exposed
    1 / 314 (0.32%)
    2 / 315 (0.63%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    2 / 314 (0.64%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Abdominal incarcerated hernia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Constipation
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Gastric varices haemorrhage
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Haematochezia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Nausea
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Oesophageal food impaction
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Small intestinal obstruction
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Steatorrhoea
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Hepatic cytolysis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Hepatitis acute
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    2 / 254 (0.79%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Diabetic nephropathy
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    End stage renal disease
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Nephrolithiasis
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Renal failure
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Musculoskeletal and connective tissue disorders
    Gouty arthritis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Muscular weakness
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Neck pain
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    3 / 314 (0.96%)
    2 / 315 (0.63%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    2 / 314 (0.64%)
    2 / 315 (0.63%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 314 (0.64%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    2 / 254 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurosyphilis
         subjects affected / exposed
    1 / 314 (0.32%)
    2 / 315 (0.63%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    1 / 252 (0.40%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    2 / 314 (0.64%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    2 / 252 (0.79%)
    0 / 254 (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 / 1
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 315 (0.63%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 315 (0.63%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 314 (0.00%)
    2 / 315 (0.63%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Bacteraemia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast abscess
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Complicated appendicitis
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Covid-19 pneumonia
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Diverticulitis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Enterobacter sepsis
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Fungaemia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Gastroenteritis viral
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Gonococcal infection
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Gonorrhoea
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Influenza
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Injection site cellulitis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Kidney infection
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Localised infection
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Mastoiditis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Meningitis cryptococcal
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Mycobacterium avium complex ~ infection
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Ophthalmic herpes zoster
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Orchitis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Pharyngeal abscess
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Pneumonia bacterial
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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 legionella
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Septic shock
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    1 / 254 (0.39%)
         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
    Soft tissue infection
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Tracheobronchitis
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Viral infection
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Wound infection
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    1 / 252 (0.40%)
    0 / 254 (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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 314 (0.32%)
    0 / 315 (0.00%)
    0 / 252 (0.00%)
    0 / 254 (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
    Hyperkalaemia
         subjects affected / exposed
    0 / 314 (0.00%)
    1 / 315 (0.32%)
    0 / 252 (0.00%)
    0 / 254 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 B/F/TAF ABC/DTG/3TC B/F/TAF to B/F/TAF ABC/DTG/3TC to B/F/TAF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    262 / 314 (83.44%)
    276 / 315 (87.62%)
    152 / 252 (60.32%)
    153 / 254 (60.24%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    12 / 314 (3.82%)
    19 / 315 (6.03%)
    6 / 252 (2.38%)
    3 / 254 (1.18%)
         occurrences all number
    13
    20
    6
    3
    Vascular disorders
    Hypertension
         subjects affected / exposed
    24 / 314 (7.64%)
    16 / 315 (5.08%)
    8 / 252 (3.17%)
    9 / 254 (3.54%)
         occurrences all number
    24
    16
    8
    9
    Nervous system disorders
    Headache
         subjects affected / exposed
    44 / 314 (14.01%)
    56 / 315 (17.78%)
    8 / 252 (3.17%)
    9 / 254 (3.54%)
         occurrences all number
    63
    70
    8
    10
    Dizziness
         subjects affected / exposed
    10 / 314 (3.18%)
    19 / 315 (6.03%)
    2 / 252 (0.79%)
    2 / 254 (0.79%)
         occurrences all number
    14
    19
    2
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    35 / 314 (11.15%)
    41 / 315 (13.02%)
    7 / 252 (2.78%)
    11 / 254 (4.33%)
         occurrences all number
    37
    48
    7
    13
    Pyrexia
         subjects affected / exposed
    15 / 314 (4.78%)
    19 / 315 (6.03%)
    8 / 252 (3.17%)
    8 / 254 (3.15%)
         occurrences all number
    18
    22
    8
    9
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    7 / 314 (2.23%)
    16 / 315 (5.08%)
    3 / 252 (1.19%)
    5 / 254 (1.97%)
         occurrences all number
    7
    18
    3
    6
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    40 / 314 (12.74%)
    77 / 315 (24.44%)
    8 / 252 (3.17%)
    7 / 254 (2.76%)
         occurrences all number
    44
    94
    8
    8
    Diarrhoea
         subjects affected / exposed
    54 / 314 (17.20%)
    57 / 315 (18.10%)
    6 / 252 (2.38%)
    13 / 254 (5.12%)
         occurrences all number
    61
    79
    6
    13
    Abdominal pain
         subjects affected / exposed
    18 / 314 (5.73%)
    23 / 315 (7.30%)
    5 / 252 (1.98%)
    6 / 254 (2.36%)
         occurrences all number
    18
    25
    6
    7
    Vomiting
         subjects affected / exposed
    18 / 314 (5.73%)
    24 / 315 (7.62%)
    3 / 252 (1.19%)
    7 / 254 (2.76%)
         occurrences all number
    20
    27
    3
    8
    Constipation
         subjects affected / exposed
    15 / 314 (4.78%)
    17 / 315 (5.40%)
    2 / 252 (0.79%)
    6 / 254 (2.36%)
         occurrences all number
    15
    17
    2
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    34 / 314 (10.83%)
    22 / 315 (6.98%)
    13 / 252 (5.16%)
    9 / 254 (3.54%)
         occurrences all number
    42
    25
    13
    10
    Oropharyngeal pain
         subjects affected / exposed
    22 / 314 (7.01%)
    35 / 315 (11.11%)
    13 / 252 (5.16%)
    6 / 254 (2.36%)
         occurrences all number
    25
    42
    15
    7
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    30 / 314 (9.55%)
    32 / 315 (10.16%)
    10 / 252 (3.97%)
    6 / 254 (2.36%)
         occurrences all number
    34
    37
    10
    6
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    31 / 314 (9.87%)
    21 / 315 (6.67%)
    11 / 252 (4.37%)
    12 / 254 (4.72%)
         occurrences all number
    31
    22
    12
    12
    Insomnia
         subjects affected / exposed
    27 / 314 (8.60%)
    35 / 315 (11.11%)
    8 / 252 (3.17%)
    5 / 254 (1.97%)
         occurrences all number
    29
    36
    8
    5
    Depression
         subjects affected / exposed
    19 / 314 (6.05%)
    27 / 315 (8.57%)
    4 / 252 (1.59%)
    12 / 254 (4.72%)
         occurrences all number
    19
    27
    4
    12
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    35 / 314 (11.15%)
    43 / 315 (13.65%)
    15 / 252 (5.95%)
    15 / 254 (5.91%)
         occurrences all number
    38
    48
    15
    15
    Arthralgia
         subjects affected / exposed
    36 / 314 (11.46%)
    41 / 315 (13.02%)
    13 / 252 (5.16%)
    12 / 254 (4.72%)
         occurrences all number
    40
    46
    13
    12
    Pain in extremity
         subjects affected / exposed
    18 / 314 (5.73%)
    13 / 315 (4.13%)
    9 / 252 (3.57%)
    12 / 254 (4.72%)
         occurrences all number
    20
    14
    11
    12
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    46 / 314 (14.65%)
    61 / 315 (19.37%)
    16 / 252 (6.35%)
    19 / 254 (7.48%)
         occurrences all number
    64
    91
    17
    23
    Syphilis
         subjects affected / exposed
    43 / 314 (13.69%)
    51 / 315 (16.19%)
    22 / 252 (8.73%)
    22 / 254 (8.66%)
         occurrences all number
    50
    63
    25
    27
    Nasopharyngitis
         subjects affected / exposed
    41 / 314 (13.06%)
    52 / 315 (16.51%)
    18 / 252 (7.14%)
    14 / 254 (5.51%)
         occurrences all number
    63
    84
    22
    18
    Anal chlamydia infection
         subjects affected / exposed
    16 / 314 (5.10%)
    29 / 315 (9.21%)
    6 / 252 (2.38%)
    11 / 254 (4.33%)
         occurrences all number
    18
    35
    8
    13
    Proctitis gonococcal
         subjects affected / exposed
    17 / 314 (5.41%)
    21 / 315 (6.67%)
    9 / 252 (3.57%)
    13 / 254 (5.12%)
         occurrences all number
    20
    26
    12
    18
    Bronchitis
         subjects affected / exposed
    20 / 314 (6.37%)
    30 / 315 (9.52%)
    3 / 252 (1.19%)
    2 / 254 (0.79%)
         occurrences all number
    20
    37
    3
    2
    Gonorrhoea
         subjects affected / exposed
    22 / 314 (7.01%)
    21 / 315 (6.67%)
    5 / 252 (1.98%)
    5 / 254 (1.97%)
         occurrences all number
    24
    25
    5
    5
    Chlamydial infection
         subjects affected / exposed
    23 / 314 (7.32%)
    13 / 315 (4.13%)
    8 / 252 (3.17%)
    8 / 254 (3.15%)
         occurrences all number
    25
    16
    8
    9
    Gastroenteritis
         subjects affected / exposed
    17 / 314 (5.41%)
    21 / 315 (6.67%)
    6 / 252 (2.38%)
    8 / 254 (3.15%)
         occurrences all number
    19
    25
    7
    8
    Influenza
         subjects affected / exposed
    22 / 314 (7.01%)
    16 / 315 (5.08%)
    4 / 252 (1.59%)
    9 / 254 (3.54%)
         occurrences all number
    22
    17
    5
    9
    Pharyngitis
         subjects affected / exposed
    17 / 314 (5.41%)
    23 / 315 (7.30%)
    6 / 252 (2.38%)
    5 / 254 (1.97%)
         occurrences all number
    19
    25
    6
    5
    Sinusitis
         subjects affected / exposed
    15 / 314 (4.78%)
    23 / 315 (7.30%)
    3 / 252 (1.19%)
    4 / 254 (1.57%)
         occurrences all number
    18
    28
    3
    4
    Covid-19
         subjects affected / exposed
    0 / 314 (0.00%)
    0 / 315 (0.00%)
    20 / 252 (7.94%)
    23 / 254 (9.06%)
         occurrences all number
    0
    0
    20
    23

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Feb 2016
    • Modified inclusion criteria to allow for local laboratory results for the screening genotype report and human leukocyte antigen (HLA)-B*5701 results • Clarified criteria for discontinuation of study treatment and for management of laboratory toxicity • Included guidance for management of potential hepatobiliary toxicity
    19 Oct 2016
    • Extended duration of blinded phase from 96 weeks of treatment to 144 weeks of treatment • Revised secondary objectives and endpoints to include Week 144 • Added open-label (OL) rollover extension and treatment assessments for participants who receive OL Biktarvy (BVY) • Revised prior and concomitant medications • Added hepatitis B virus (HBV) and hepatitis C virus (HCV) serology testing at Week 48 and every 48 weeks after Week 48 • Revised Gilead reporting requirements to clarify that, in addition to using the reference safety information in the investigator’s brochure and relevant local label as applicable, Gilead may also use the EU summary of product characteristics for the assessment of expectedness of serious adverse events (SAEs) for ABC/DTG/3TC • Revised the definition of special situations • Added peripheral blood mononuclear cell (PBMC) collection at Week 132 in the PBMC substudy • Revised biomarker analysis
    06 May 2019
    • Extended the duration of the OL extension phase of the study from up to 48 weeks to 96 weeks to allow collection of longer term safety and efficacy data. • Revised Secondary Objectives and End Points • Revised Duration of Treatment • Revised Procedures for Breaking Treatment Codes • Added Prior and Concomitant Medications Table for GS-9883/F/TAF Open Label Extension • Revised end of blinded treatment visit • Revised Treatment Assessments (Open-Label Rollover Extension) • Revised Bone Safety Evaluations and Bone Mineral Density Evaluations • Revised Markers of Renal Tubular Function • Revised participant with HIV-1 ribonucleic acid (RNA) ≥ 50 copies/mL instructions to include Week 96 OL • Revised from Gilead Drug Safety and Public Health (DSPH) to Gilead Pharmacovigilance and Epidemiology (PVE) throughout the protocol amendment • Revised instructions for reporting special situations • Added All GS-9883/F/TAF Analysis Set • Added Efficacy Analyses for All GS-9883/F/TAF Analysis • Revised Safety Analysis • Revised Analysis Schedule • Revised Appendix 2 footnotes • Revised Appendix 3 to include OL visits through 96 weeks

    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/28867497
    http://www.ncbi.nlm.nih.gov/pubmed/29956087
    http://www.ncbi.nlm.nih.gov/pubmed/30803969
    http://www.ncbi.nlm.nih.gov/pubmed/31068270
    http://www.ncbi.nlm.nih.gov/pubmed/32504574
    http://www.ncbi.nlm.nih.gov/pubmed/33880558
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