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    Clinical Trial Results:
    A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching from an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 65 Years

    Summary
    EudraCT number
    2017-003428-61
    Trial protocol
    GB   BE   ES   FR   IT  
    Global end of trial date
    29 May 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    22 Nov 2020
    First version publication date
    22 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-380-4449
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03405935
    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
    29 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    29 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to characterize the virologic efficacy of switching virologically suppressed participants on an elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) regimen or a tenofovir disoproxil fumarate (TDF) containing regimen to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC.
    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
    01 Mar 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 27
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    France: 28
    Country: Number of subjects enrolled
    Italy: 22
    Worldwide total number of subjects
    86
    EEA total number of subjects
    86
    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)
    0
    From 65 to 84 years
    86
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at study sites in Europe. The first participant was screened on 01 March 2018. The last study visit occurred on 29 May 2020.

    Pre-assignment
    Screening details
    90 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    B/F/TAF
    Arm description
    Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    B/F/TAF
    Investigational medicinal product code
    Other name
    Biktarvy®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50/200/25 mg administered once daily for up to Week 96

    Number of subjects in period 1
    B/F/TAF
    Started
    86
    Completed
    78
    Not completed
    8
         Death
    2
         Withdrawal by Subject
    1
         Adverse Event
    3
         Lost to follow-up
    2

    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) FDC tablet once daily, without regard to food for at least 96 weeks.

    Reporting group values
    B/F/TAF Total
    Number of subjects
    86 86
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    70 ± 3.8 -
    Gender categorical
    Units: Subjects
        Female
    11 11
        Male
    75 75
    Race
    Not Permitted = Data not collected due to regional regulations or participant refused to provide information
    Units: Subjects
        American Indian or Alaska Native
    0 0
        Asian
    0 0
        Black
    1 1
        Native Hawaiian or Pacific Islander
    0 0
        White
    82 82
        Other
    0 0
        Not Permitted
    3 3
    Ethnicity
    Not Permitted = Data not collected due to regional regulations or participant refused to provide information
    Units: Subjects
        Hispanic or Latino
    12 12
        Not Hispanic or Latino
    71 71
        Not Permitted
    3 3
    Human Immunodeficiency Virus-1 Ribonucleic acid (HIV-1 RNA) Category
    Units: Subjects
        < 50 copies/ mL
    84 84
        ≥ 50 copies/ mL
    2 2
    CD4 Cell Count Category
    Units: Subjects
        < 50 cells/μL
    0 0
        ≥ 50 to < 200 cells/μL
    2 2
        ≥ 200 to < 350 cells/μL
    7 7
        ≥ 350 to < 500 cells/μL
    9 9
        ≥ 500 cells/ μL
    68 68
    Cluster of Differentiation 4 (CD4) Cell Count
    Units: cells/μL
        arithmetic mean (standard deviation)
    694 ± 273.6 -
    CD4 Percentage
    Units: percentage of lymphocytes
        arithmetic mean (standard deviation)
    33.4 ± 9.24 -

    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) FDC tablet once daily, without regard to food for at least 96 weeks.

    Primary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the Food and Drug Administration (FDA)-Defined Snapshot Algorithm [1]
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint within an allowed window of time, along with study drug discontinuation status. The Full Analysis Set (FAS) included all participants who were enrolled and received at least 1 dose of study drug; and did not have major protocol violations.
    End point type
    Primary
    End point timeframe
    Week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    B/F/TAF
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    97.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Adverse Events (AEs) Through Week 24

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    End point title
    Percentage of Participants Experiencing Adverse Events (AEs) Through Week 24
    End point description
    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs. The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    First dose date up to Week 24
    End point values
    B/F/TAF
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    62.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing AEs Through Week 48

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    End point title
    Percentage of Participants Experiencing AEs Through Week 48
    End point description
    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs. Participants in the Safety Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    First dose date Up to Week 48
    End point values
    B/F/TAF
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    81.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing AEs Through Week 72

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    End point title
    Percentage of Participants Experiencing AEs Through Week 72
    End point description
    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs. Participants in the Safety Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    First dose date Up to Week 72
    End point values
    B/F/TAF
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    94.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing AEs Through Week 96

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    End point title
    Percentage of Participants Experiencing AEs Through Week 96
    End point description
    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal product, which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs may also included pre- or post-treatment complications that occurred as a result of protocol specified procedures, lack of efficacy, overdose, drug abuse/misuse reports, or occupational exposure. Preexisting events that increased in severity or changed in nature during or as a consequence of participation in the clinical study were also considered AEs. Participants in the Safety Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    First dose date Up to Week 96
    End point values
    B/F/TAF
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    95.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA-Defined Snapshot Algorithm

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint 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
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    90.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72 as Defined by the FDA-Defined Snapshot Algorithm

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72 as Defined by the FDA-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 72 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint 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 72
    End point values
    B/F/TAF
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    94.2
    No statistical analyses for this end point

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

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defined a participant's virologic response status using only the viral load at the predefined timepoint 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
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    74.4
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count at Week 24

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    End point title
    Change From Baseline in CD4 Cell Count at Week 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    B/F/TAF
    Number of subjects analysed
    84
    Units: cells/μL
        arithmetic mean (standard deviation)
    20 ± 141.8
    No statistical analyses for this end point

    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
    Number of subjects analysed
    76
    Units: cells/μL
        arithmetic mean (standard deviation)
    8 ± 174.8
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Cell Count at Week 72

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    End point title
    Change From Baseline in CD4 Cell Count at Week 72
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 72
    End point values
    B/F/TAF
    Number of subjects analysed
    78
    Units: cells/μL
        arithmetic mean (standard deviation)
    36 ± 145.7
    No statistical analyses for this end point

    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
    Number of subjects analysed
    59
    Units: cells/μL
        arithmetic mean (standard deviation)
    22 ± 150.9
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at Week 24

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    End point title
    Change From Baseline in CD4 Percentage at Week 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    B/F/TAF
    Number of subjects analysed
    84
    Units: percentage of lymphocytes
        arithmetic mean (standard deviation)
    0.1 ± 3.52
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at Week 48

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    End point title
    Change From Baseline in CD4 Percentage at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 48
    End point values
    B/F/TAF
    Number of subjects analysed
    76
    Units: percentage of lymphocytes
        arithmetic mean (standard deviation)
    0.1 ± 3.89
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at Week 72

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    End point title
    Change From Baseline in CD4 Percentage at Week 72
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 72
    End point values
    B/F/TAF
    Number of subjects analysed
    78
    Units: percentage of lymphocytes
        arithmetic mean (standard deviation)
    -0.1 ± 4.29
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage at Week 96

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    End point title
    Change From Baseline in CD4 Percentage at Week 96
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 96
    End point values
    B/F/TAF
    Number of subjects analysed
    59
    Units: percentage of lymphocytes
        arithmetic mean (standard deviation)
    -0.1 ± 4.34
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Failure Approach

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Failure Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    B/F/TAF
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    97.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Failure Approach

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Failure Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    B/F/TAF
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    90.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Failure Approach

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Failure Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 72 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 72
    End point values
    B/F/TAF
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    94.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Failure Approach

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Failure Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using missing = failure approach. In this approach, all missing data were treated as HIV-1 RNA ≥ 50 copies/mL. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    B/F/TAF
    Number of subjects analysed
    86
    Units: percentage of participants
        number (not applicable)
    79.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Excluded Approach

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24, as Analyzed by Missing = Excluded Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    B/F/TAF
    Number of subjects analysed
    84
    Units: percentage of participants
        number (not applicable)
    100.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Excluded Approach

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48, as Analyzed by Missing = Excluded Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    B/F/TAF
    Number of subjects analysed
    78
    Units: percentage of participants
        number (not applicable)
    100.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Excluded Approach

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 72, as Analyzed by Missing = Excluded Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 72 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 72
    End point values
    B/F/TAF
    Number of subjects analysed
    81
    Units: percentage of participants
        number (not applicable)
    100.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Excluded Approach

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    End point title
    Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96, as Analyzed by Missing = Excluded Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using missing = excluded approach. In this approach, all missing data were excluded in the computation of the percentages (ie, missing data points were excluded from both the numerator and denominator in the computation). Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    B/F/TAF
    Number of subjects analysed
    68
    Units: percentage of participants
        number (not applicable)
    100.0
    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 of study drug up to last dose plus 30 days ( up to Week 102.9); All-Cause Mortality: First dose date up to Week 102.9
    Adverse event reporting additional description
    The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    B/F/TAF
    Reporting group description
    B/F/TAF (50/200/25 mg) FDC tablet once daily, without regard to food for at least 96 weeks.

    Serious adverse events
    B/F/TAF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    9 / 86 (10.47%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Intentional overdose
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Depression
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Suicide attempt
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Covid-19 pneumonia
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Endocarditis
         subjects affected / exposed
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    B/F/TAF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 86 (39.53%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    8 / 86 (9.30%)
         occurrences all number
    8
    Nervous system disorders
    Sciatica
         subjects affected / exposed
    5 / 86 (5.81%)
         occurrences all number
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 86 (6.98%)
         occurrences all number
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 86 (9.30%)
         occurrences all number
    8
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    10 / 86 (11.63%)
         occurrences all number
    11
    Nasopharyngitis
         subjects affected / exposed
    7 / 86 (8.14%)
         occurrences all number
    9
    Urinary tract infection
         subjects affected / exposed
    5 / 86 (5.81%)
         occurrences all number
    6

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Jan 2018
    - Added biomarker blood sample evaluation: A portion of the biomarker blood sample obtained at Day 1, Weeks 4, 12, 24, and 48 may be utilized to assess study drug pharmacokinetics (PK). This will be a random sample with the date and time of the participant's last medication dose recorded. - 3 inclusion criteria were added: 1) Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) ≤ 5 * upper limit of normal (ULN); 2) Total bilirubin ≤ 1.5 * ULN or normal direct bilirubin; 3) Adequate hematologic function (absolute neutrophil count ≥ 750/mm^3 [≥ 0.75 GI/L], platelets ≥ 50,000/mm^3 [≥ 50 GI/L], and hemoglobin ≥ 8.5 g/dL [≥ 85 g/L]) - Concomitant Medication table was modified to be in alignment with the Package Insert for the drug. - Medical history information collected at screening visit was modified. - Development of active tuberculosis infection was added to the criteria for discontinuation of study treatment. - A section on Hepatitis C Management was added. - Safety data collection was clarified. - Statistical clarification was provided for the efficacy analyses.
    18 Dec 2018
    - All applicable text was revised to reflect study treatment duration change from Week 48 to Week 96. - Prior and Concomitant Medications and Exclusion Criteria tables were updated for consistency and to ensure that the latest disallowed drug information was included. - Study GS-US-311-1717 was added to the list of relevant studies.

    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
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