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    Clinical Trial Results:
    A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects who are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

    Summary
    EudraCT number
    		 2014-004545-27
    Trial protocol
    		 SE   DE   GB   BE   ES   NL   IT  
    Global end of trial date
    09 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2020
    First version publication date
    01 Jan 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-366-1216
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02345252
    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
    09 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jan 2019
    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 noninferiority of switching to emtricitabine/rilpivirine /tenofovir alafenamide (FTC/RPV/TAF) fixed-dose combination (FDC) as compared to continuing FTC/RPV/tenofovir disoproxil fumarate (TDF) FDC (FTC/RPV/TDF) in virologically suppressed HIV-1 infected participants.
    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
    26 Jan 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
    Netherlands: 7
    Country: Number of subjects enrolled
    Spain: 30
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 57
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    United States: 440
    Country: Number of subjects enrolled
    Canada: 35
    Country: Number of subjects enrolled
    Puerto Rico: 9
    Country: Number of subjects enrolled
    Switzerland: 8
    Worldwide total number of subjects
    632
    EEA total number of subjects
    140
    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)
    615
    From 65 to 84 years
    17
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Europe and North America. The first participant was screened on 26 January 2015. The last study visit occurred on 09 January 2019.

    Pre-assignment
    Screening details
    		 690 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FTC/RPV/TAF
    Arm description
    		 Double-Blind Phase: FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Emtricitabine/Rilpivirine/Tenofovir Alafenamide
    Investigational medicinal product code
    Other name
    FTC/RPV/TAF, Odefsey®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25/25 mg FDC tablets administered orally once daily

    Investigational medicinal product name
    Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered orally once daily

    Arm title
    		 FTC/RPV/TDF
    Arm description
    		 Double-Blind Phase: FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate
    Investigational medicinal product code
    Other name
    FTC/RPV/TDF, Eviplera®, Complera®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25/300 mg FDC tablets administered orally once daily

    Investigational medicinal product name
    Emtricitabine/Rilpivirine/Tenofovir Alafenamide Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablets administered orally once daily

    Number of subjects in period 1 [1]
    		FTC/RPV/TAF FTC/RPV/TDF
    Started
    316
    314
    Completed
    276
    267
    Not completed
    40
    47
         Non- Compliance with Study Drug
    1
    2
         Withdrew Consent
    21
    23
         Adverse Event
    2
    3
         Death
    1
    2
         Investigator's Discretion
    4
    6
         Protocol Violation
    2
    1
         Lost to follow-up
    8
    10
         Lack of efficacy
    1
    -
    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: 2 participants in FTC/RPV/TDF group who were randomized but not treated are not included in the subject disposition table.
    Period 2
    Period 2 title
    Open-Label Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FTC/RPV/TAF to FTC/RPV/TAF
    Arm description
    		 Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Emtricitabine/Rilpivirine/Tenofovir Alafenamide
    Investigational medicinal product code
    Other name
    FTC/RPV/TAF, Odefsey®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25/25 mg FDC tablets administered orally once daily

    Arm title
    		 FTC/RPV/TDF to FTC/RPV/TAF
    Arm description
    		 Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Emtricitabine/Rilpivirine/Tenofovir Alafenamide
    Investigational medicinal product code
    Other name
    FTC/RPV/TAF, Odefsey®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/25/25 mg FDC tablets administered orally once daily

    Number of subjects in period 2 [2]
    		FTC/RPV/TAF to FTC/RPV/TAF FTC/RPV/TDF to FTC/RPV/TAF
    Started
    19
    17
    Completed
    19
    17
    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: 507 participants (FTC/RPV/TAF: N = 257; FTC/RPV/TDF: N = 250) completed the Double-Blind Phase, but did not enter the Open-Label Extension Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FTC/RPV/TAF
    Reporting group description
    		 Double-Blind Phase: FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.

    Reporting group title
    FTC/RPV/TDF
    Reporting group description
    		 Double-Blind Phase: FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.

    Reporting group values
    		 FTC/RPV/TAF FTC/RPV/TDF Total
    Number of subjects
    		 316 314 630
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45 ( 10.4 ) 44 ( 10.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 41 25 66
        Male
    		 275 289 564
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 2 3
        Asian
    		 7 17 24
        Black
    		 65 54 119
        Native Hawaiian or Pacific Islander
    		 0 1 1
        White
    		 238 235 473
        Other
    		 5 5 10
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 40 53 93
        Not Hispanic or Latino
    		 275 261 536
        Not Permitted
    		 1 0 1
    HIV-1 RNA Category
    Units: Subjects
        < 50 copies/mL
    		 307 312 619
        ≥ 50 copies/mL
    		 9 2 11
    CD4 Cell Count Category
    Units: Subjects
        ≥ 50 to < 200 cells/μL
    		 5 1 6
        ≥ 200 to < 350 cells/μL
    		 10 16 26
        ≥ 350 to < 500 cells/μL
    		 52 50 102
        ≥ 500 cells/ μL
    		 249 247 496
    CD4 Cell Count
    Units: cells/μL
        arithmetic mean (standard deviation)
    		 711 ( 278.9 ) 707 ( 264.7 ) -

    End points

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    End points reporting groups
    Reporting group title
    FTC/RPV/TAF
    Reporting group description
    		 Double-Blind Phase: FTC/RPV/TAF (200/25/25 mg) FDC tablet + FTC/RPV/TDF placebo tablet orally once daily for up to 96 weeks.

    Reporting group title
    FTC/RPV/TDF
    Reporting group description
    		 Double-Blind Phase: FTC/RPV/TDF (200/25/300 mg) FDC tablet + FTC/RPV/TAF placebo tablet orally once daily for up to 96 weeks.
    Reporting group title
    FTC/RPV/TAF to FTC/RPV/TAF
    Reporting group description
    		 Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first.

    Reporting group title
    FTC/RPV/TDF to FTC/RPV/TAF
    Reporting group description
    		 Open-Label Extension Phase: After the Week 96 visit, participants were given the option to receive open label FTC/RPV/TAF FDC for up to an additional 48 weeks. In countries where FTC/RPV/TAF FDC was not yet commercially available, participants were given the option to receive open-label FTC/RPV/TAF FDC orally once daily and attend visits every 12 weeks until FTC/RPV/TAF FDC became commercially available, or until Gilead elected to discontinue the study, whichever occurred first.

    Primary: Percentage of Participants With 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 With 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 patient'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. The Full Analysis Set included participants who were randomized and received at least 1 dose of study drug and were on FTC/RPV/TDF prior to the screening visit.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 FTC/RPV/TAF FTC/RPV/TDF
    Number of subjects analysed
    316
    313
    Units: percentage of participants
        number (not applicable)
    93.7
    93.9
    Statistical analysis title
    		 Statistical Analysis 1- FTC/RPV/TAF vs FTC/RPV/TDF
    Statistical analysis description
    The null hypothesis was that the percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 in FTC/RPV/TAF group was at least 8% lower than the rate in FTC/RPV/TDF group; alternative hypothesis was that the percentage of participants with HIV-1 RNA < 50 copies/mL in FTC/RPV/TAF group was less than 8% lower than that in FTC/RPV/TDF group. The difference in percentages and its 95.001% CI were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
    Comparison groups
    FTC/RPV/TAF v FTC/RPV/TDF
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    -0.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 3.7
    Notes
    [1] - A sample size of 275 HIV-1 infected participants per treatment group would provide 85% power to detect a noninferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and FTC/RPV/TDF group. For sample size and power computation, it is assumed that both treatment groups will have a response rate of 89%(based on Gilead Study GS-US-292-0109), that a noninferiority margin is 8%, and that the significance level of the test is at a one-sided alpha level of 0.025.
    Statistical analysis title
    		 Statistical Analysis 2- FTC/RPV/TAF vs FTC/RPV/TDF
    Comparison groups
    FTC/RPV/TAF v FTC/RPV/TDF
    Number of subjects included in analysis
    629
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Percentage of Participants With 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 With 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 with HIV-1 RNA ≥ 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient'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
    		 FTC/RPV/TAF FTC/RPV/TDF
    Number of subjects analysed
    316
    313
    Units: percentage of participants
        number (not applicable)
    0.6
    0
    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 US FDA-Defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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
    		 FTC/RPV/TAF FTC/RPV/TDF
    Number of subjects analysed
    316
    313
    Units: percentage of participants
        number (not applicable)
    0.6
    1.0
    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 US FDA-Defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a patient'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
    		 FTC/RPV/TAF FTC/RPV/TDF
    Number of subjects analysed
    316
    313
    Units: percentage of participants
        number (not applicable)
    89.2
    88.5
    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 on-treatment data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 FTC/RPV/TAF FTC/RPV/TDF
    Number of subjects analysed
    296
    293
    Units: cells/μL
        arithmetic mean (standard deviation)
    9 ( 159.7 )
    -1 ( 152.7 )
    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 on-treatment data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 96
    End point values
    		 FTC/RPV/TAF FTC/RPV/TDF
    Number of subjects analysed
    283
    277
    Units: cells/μL
        arithmetic mean (standard deviation)
    12 ( 180.6 )
    16 ( 171.9 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48

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    End point title
    		 Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 48
    End point description
    Hip BMD was assessed by dual energy x-ray absorptiometry (DXA) scan. Participants in the Hip DXA Analysis Set (all randomized participants who received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 FTC/RPV/TAF FTC/RPV/TDF
    Number of subjects analysed
    168
    165
    Units: percentage change
        arithmetic mean (standard deviation)
    1.040 ( 1.9404 )
    -0.245 ( 2.0805 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Hip BMD at Week 96

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    End point title
    		 Percent Change From Baseline in Hip BMD at Week 96
    End point description
    Hip BMD was assessed by DXA scan. 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
    		 FTC/RPV/TAF FTC/RPV/TDF
    Number of subjects analysed
    160
    156
    Units: percentage change
        arithmetic mean (standard deviation)
    1.623 ( 2.4575 )
    -0.613 ( 2.7411 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Spine BMD at Week 48

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    End point title
    		 Percent Change From Baseline in Spine BMD at Week 48
    End point description
    Spine BMD was assessed by DXA scan. Participants in the spine DXA Analysis Set (all randomized participants who received at least 1 dose of study drug, and had nonmissing baseline hip BMD value) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 FTC/RPV/TAF FTC/RPV/TDF
    Number of subjects analysed
    172
    168
    Units: percent change
        arithmetic mean (standard deviation)
    1.613 ( 3.4346 )
    0.075 ( 2.9605 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Spine BMD at Week 96

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    End point title
    		 Percent Change From Baseline in Spine BMD at Week 96
    End point description
    Spine BMD was assessed by DXA scan. 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
    		 FTC/RPV/TAF FTC/RPV/TDF
    Number of subjects analysed
    162
    158
    Units: percent change
        arithmetic mean (standard deviation)
    2.039 ( 3.5098 )
    -0.250 ( 3.5903 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose date to last dose date (maximum duration: 173.1 weeks) plus 30 days
    Adverse event reporting additional description
    The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    FTC/RPV/TAF (Double-Blind Phase)
    Reporting group description
    		 Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TAF group, who received FTC/RPV/TAF (200/25/25 mg) FDC tablet plus FTC/RPV/TDF placebo tablet administered orally once daily.

    Reporting group title
    FTC/RPV/TDF (Double-Blind Phase)
    Reporting group description
    		 Adverse events reported occurred during the Double-Blind Phase in participants from the FTC/RPV/TDF group, who received FTC/RPV/TDF (200/25/300 mg) FDC tablet plus FTC/RPV/TAF placebo tablet administered orally once daily.

    Reporting group title
    Open-Label FTC/RPV/TAF From FTC/RPV/TAF
    Reporting group description
    		 Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the FTC/RPV/TAF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.

    Reporting group title
    Open-Label FTC/RPV/TAF From FTC/RPV/TDF
    Reporting group description
    		 Adverse events reported occurred during the Open-Label Extension Phase in participants who enrolled into the Open-Label Extension Phase from the FTC/RPV/TDF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.

    Serious adverse events
    		 FTC/RPV/TAF (Double-Blind Phase) FTC/RPV/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From FTC/RPV/TDF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 316 (11.39%)
    29 / 314 (9.24%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    1
    2
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Renal neoplasm
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    2 / 316 (0.63%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Generalised oedema
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Social circumstances
    Substance use
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Reproductive system and breast disorders
    Priapism
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    3 / 316 (0.95%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Asthma
         subjects affected / exposed
    0 / 316 (0.00%)
    2 / 314 (0.64%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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 polyps
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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 granuloma
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Respiratory failure
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    2 / 316 (0.63%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 316 (0.32%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Completed suicide
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Depression suicidal
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Suicide attempt
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Toxicity to various agents
         subjects affected / exposed
    1 / 316 (0.32%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Hyphaema
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Meniscus injury
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Overdose
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Procedural pain
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Radius fracture
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 316 (0.32%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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 myocardial infarction
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Angina unstable
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Coronary artery disease
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Myocardial infarction
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    2 / 316 (0.63%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Carotid artery aneurysm
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Paraplegia
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Abdominal pain
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Colitis
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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 ulcer perforation
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Inguinal hernia
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 316 (0.32%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Bile duct stone
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Cholelithiasis
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    1 / 316 (0.32%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Calculus urethral
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Nephrolithiasis
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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 colic
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Osteoarthritis
         subjects affected / exposed
    2 / 316 (0.63%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Rhabdomyolysis
         subjects affected / exposed
    1 / 316 (0.32%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Muscular weakness
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    1 / 316 (0.32%)
    4 / 314 (1.27%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    3 / 316 (0.95%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Diverticulitis
         subjects affected / exposed
    0 / 316 (0.00%)
    2 / 314 (0.64%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    2 / 316 (0.63%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Pneumonia
         subjects affected / exposed
    1 / 316 (0.32%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Sepsis
         subjects affected / exposed
    1 / 316 (0.32%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Abscess limb
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Anal chlamydia infection
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Bronchitis
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Cellulitis staphylococcal
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 316 (0.00%)
    0 / 314 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (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
    Gastroenteritis cryptosporidial
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Helicobacter infection
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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 A
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Myelitis
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Osteomyelitis acute
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Pharyngitis
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Proctitis gonococcal
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Subcutaneous abscess
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    Syphilis
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    0 / 17 (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
    Tooth abscess
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    0 / 17 (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
    		 FTC/RPV/TAF (Double-Blind Phase) FTC/RPV/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From FTC/RPV/TDF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    249 / 316 (78.80%)
    234 / 314 (74.52%)
    14 / 19 (73.68%)
    11 / 17 (64.71%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lipoma
         subjects affected / exposed
    2 / 316 (0.63%)
    0 / 314 (0.00%)
    2 / 19 (10.53%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    22 / 316 (6.96%)
    9 / 314 (2.87%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    22
    9
    0
    0
    Varicose vein
         subjects affected / exposed
    2 / 316 (0.63%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    2
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    17 / 316 (5.38%)
    28 / 314 (8.92%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    18
    29
    0
    0
    Pyrexia
         subjects affected / exposed
    7 / 316 (2.22%)
    13 / 314 (4.14%)
    0 / 19 (0.00%)
    3 / 17 (17.65%)
         occurrences all number
    7
    15
    0
    4
    Influenza like illness
         subjects affected / exposed
    2 / 316 (0.63%)
    3 / 314 (0.96%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    4
    4
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    7 / 316 (2.22%)
    5 / 314 (1.59%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    8
    5
    1
    0
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    9 / 316 (2.85%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    9
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    22 / 316 (6.96%)
    24 / 314 (7.64%)
    2 / 19 (10.53%)
    3 / 17 (17.65%)
         occurrences all number
    24
    25
    2
    4
    Asthma
         subjects affected / exposed
    6 / 316 (1.90%)
    4 / 314 (1.27%)
    1 / 19 (5.26%)
    1 / 17 (5.88%)
         occurrences all number
    7
    4
    2
    2
    Rhinitis allergic
         subjects affected / exposed
    8 / 316 (2.53%)
    3 / 314 (0.96%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    8
    3
    1
    0
    Haemoptysis
         subjects affected / exposed
    0 / 316 (0.00%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    20 / 316 (6.33%)
    13 / 314 (4.14%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    20
    17
    0
    0
    Anxiety
         subjects affected / exposed
    17 / 316 (5.38%)
    13 / 314 (4.14%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    17
    13
    0
    1
    Insomnia
         subjects affected / exposed
    11 / 316 (3.48%)
    18 / 314 (5.73%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    11
    20
    0
    1
    Depressed mood
         subjects affected / exposed
    1 / 316 (0.32%)
    2 / 314 (0.64%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    2
    0
    1
    Sleep sex
         subjects affected / exposed
    0 / 316 (0.00%)
    0 / 314 (0.00%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Weight decreased
         subjects affected / exposed
    3 / 316 (0.95%)
    3 / 314 (0.96%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    3
    3
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    10 / 316 (3.16%)
    5 / 314 (1.59%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    11
    5
    1
    0
    Post-traumatic pain
         subjects affected / exposed
    1 / 316 (0.32%)
    3 / 314 (0.96%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    3
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    25 / 316 (7.91%)
    24 / 314 (7.64%)
    0 / 19 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    32
    26
    0
    2
    Dizziness
         subjects affected / exposed
    11 / 316 (3.48%)
    11 / 314 (3.50%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    11
    12
    0
    1
    Paraesthesia
         subjects affected / exposed
    8 / 316 (2.53%)
    7 / 314 (2.23%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    8
    7
    1
    0
    Sciatica
         subjects affected / exposed
    4 / 316 (1.27%)
    18 / 314 (5.73%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    4
    1
    1
    0
    Syncope
         subjects affected / exposed
    2 / 316 (0.63%)
    2 / 314 (0.64%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    2
    2
    1
    0
    Facial paralysis
         subjects affected / exposed
    0 / 316 (0.00%)
    3 / 314 (0.96%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    3
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    5 / 316 (1.58%)
    3 / 314 (0.96%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    5
    3
    1
    0
    Eye disorders
    Retinal detachment
         subjects affected / exposed
    1 / 316 (0.32%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    2
    0
    1
    Blepharitis
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 316 (0.00%)
    0 / 314 (0.00%)
    2 / 19 (10.53%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Eye pain
         subjects affected / exposed
    0 / 316 (0.00%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    1
    Meibomianitis
         subjects affected / exposed
    0 / 316 (0.00%)
    0 / 314 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    34 / 316 (10.76%)
    40 / 314 (12.74%)
    1 / 19 (5.26%)
    2 / 17 (11.76%)
         occurrences all number
    42
    46
    1
    2
    Nausea
         subjects affected / exposed
    20 / 316 (6.33%)
    11 / 314 (3.50%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    21
    11
    0
    0
    Vomiting
         subjects affected / exposed
    17 / 316 (5.38%)
    10 / 314 (3.18%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    18
    10
    0
    0
    Flatulence
         subjects affected / exposed
    5 / 316 (1.58%)
    8 / 314 (2.55%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    5
    8
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    6 / 316 (1.90%)
    6 / 314 (1.91%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    6
    7
    1
    0
    Inguinal hernia
         subjects affected / exposed
    2 / 316 (0.63%)
    0 / 314 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    6 / 316 (1.90%)
    4 / 314 (1.27%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    7
    4
    1
    0
    Pruritus
         subjects affected / exposed
    5 / 316 (1.58%)
    2 / 314 (0.64%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    6
    2
    1
    0
    Rash papular
         subjects affected / exposed
    1 / 316 (0.32%)
    2 / 314 (0.64%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    2
    1
    0
    Skin fissures
         subjects affected / exposed
    1 / 316 (0.32%)
    0 / 314 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    5 / 316 (1.58%)
    5 / 314 (1.59%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    6
    5
    1
    0
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 316 (0.32%)
    1 / 314 (0.32%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    28 / 316 (8.86%)
    34 / 314 (10.83%)
    2 / 19 (10.53%)
    1 / 17 (5.88%)
         occurrences all number
    31
    39
    4
    1
    Arthralgia
         subjects affected / exposed
    24 / 316 (7.59%)
    32 / 314 (10.19%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    26
    32
    0
    1
    Pain in extremity
         subjects affected / exposed
    25 / 316 (7.91%)
    16 / 314 (5.10%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    25
    16
    1
    0
    Myalgia
         subjects affected / exposed
    10 / 316 (3.16%)
    9 / 314 (2.87%)
    0 / 19 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    10
    9
    0
    2
    Osteoarthritis
         subjects affected / exposed
    11 / 316 (3.48%)
    40 / 314 (12.74%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    11
    4
    1
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    4 / 316 (1.27%)
    4 / 314 (1.27%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    4
    4
    0
    1
    Muscle contracture
         subjects affected / exposed
    1 / 316 (0.32%)
    1 / 314 (0.32%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    0
    1
    Rhabdomyolysis
         subjects affected / exposed
    0 / 316 (0.00%)
    0 / 314 (0.00%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    49 / 316 (15.51%)
    46 / 314 (14.65%)
    0 / 19 (0.00%)
    3 / 17 (17.65%)
         occurrences all number
    60
    65
    0
    3
    Upper respiratory tract infection
         subjects affected / exposed
    47 / 316 (14.87%)
    46 / 314 (14.65%)
    1 / 19 (5.26%)
    1 / 17 (5.88%)
         occurrences all number
    70
    57
    1
    1
    Bronchitis
         subjects affected / exposed
    22 / 316 (6.96%)
    23 / 314 (7.32%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    28
    27
    1
    0
    Sinusitis
         subjects affected / exposed
    20 / 316 (6.33%)
    23 / 314 (7.32%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    27
    34
    0
    0
    Syphilis
         subjects affected / exposed
    16 / 316 (5.06%)
    23 / 314 (7.32%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    17
    24
    0
    0
    Influenza
         subjects affected / exposed
    19 / 316 (6.01%)
    18 / 314 (5.73%)
    0 / 19 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    19
    21
    0
    0
    Pharyngitis
         subjects affected / exposed
    14 / 316 (4.43%)
    13 / 314 (4.14%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    16
    14
    1
    0
    Gastroenteritis
         subjects affected / exposed
    10 / 316 (3.16%)
    11 / 314 (3.50%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    12
    12
    1
    0
    Chlamydial infection
         subjects affected / exposed
    10 / 316 (3.16%)
    8 / 314 (2.55%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    11
    9
    1
    0
    Anal chlamydia infection
         subjects affected / exposed
    3 / 316 (0.95%)
    9 / 314 (2.87%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    4
    9
    1
    0
    Tooth infection
         subjects affected / exposed
    5 / 316 (1.58%)
    6 / 314 (1.91%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    6
    7
    1
    0
    Onychomycosis
         subjects affected / exposed
    4 / 316 (1.27%)
    6 / 314 (1.91%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    4
    6
    1
    0
    Oral herpes
         subjects affected / exposed
    6 / 316 (1.90%)
    3 / 314 (0.96%)
    2 / 19 (10.53%)
    0 / 17 (0.00%)
         occurrences all number
    6
    4
    2
    0
    Genital herpes
         subjects affected / exposed
    3 / 316 (0.95%)
    5 / 314 (1.59%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    3
    7
    1
    0
    Fungal skin infection
         subjects affected / exposed
    3 / 316 (0.95%)
    4 / 314 (1.27%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    3
    5
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 316 (0.32%)
    6 / 314 (1.91%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    1
    6
    1
    0
    Rhinitis
         subjects affected / exposed
    5 / 316 (1.58%)
    2 / 314 (0.64%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    5
    5
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    3 / 316 (0.95%)
    2 / 314 (0.64%)
    0 / 19 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    3
    3
    0
    1
    Papilloma viral infection
         subjects affected / exposed
    2 / 316 (0.63%)
    2 / 314 (0.64%)
    1 / 19 (5.26%)
    0 / 17 (0.00%)
         occurrences all number
    2
    2
    1
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jan 2015
    • The inclusion criterion relating to documented resistance was expanded to include thymidine analog-associated mutations (TAMs). • The assessment window for a repeat HIV-1 RNA test if viral load was ≥ 50 copies/mL was changed to 2 to 4 weeks.
    09 Sep 2015
    • The study design was changed to allow subjects in the UK to participate in the open-label phase. • It was specified that pharmacokinetic (PK) blood samples did not have to be collected in a fasted state. • It was clarified that if initial DXA scans were not collected before study drug administration at baseline/Day 1 or if the scan was not acceptable, subsequent scans were not required. Also, if either the hip or spine DXA scan was not collected at baseline/Day 1, subsequent scans were expected to contain only the region (ie, hip and/or spine) that was scanned successfully at the baseline/Day 1 visit. • The management of changes in BMD by investigators was clarified.
    28 Mar 2016
    • The blinded phase of the study was extended from 48 weeks to 96 weeks, with corresponding changes to the study assessments. • A secondary objective was added to evaluate the efficacy, safety, and tolerability of the 2 treatment groups through Week 96, and other secondary objectives were revised to include assessment at Week 96 (as well as at Week 48). • Secondary efficacy endpoints were added to calculate the proportion of subjects with HIV-1 RNA ≥ 50 copies/mL at Weeks 48 and 96, and the proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 96, as determined by the US FDA-defined snapshot algorithm. The secondary efficacy endpoint for change from baseline in CD4 cell count was revised to include assessment at Week 96 (as well as at Week 48). • The definitions of the Full Analysis Set (FAS) and Per Protocol (PP) Analysis Set were expanded to include subjects who were receiving CPA prior to the screening visit. Further details were included on the exclusion criteria for the Week 48 PP Analysis Set. • It was specified that, on an ongoing basis, adverse events (AEs) would be reviewed for events that might meet the definition of a Stage 3 opportunistic illness of an AIDS-defining diagnosis.

    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/30101539
    http://www.ncbi.nlm.nih.gov/pubmed/28259777
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