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    Clinical Trial Results:
    A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching from a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects

    Summary
    EudraCT number
    		 2014-004779-21
    Trial protocol
    		 DE   GB   BE   ES   NL  
    Global end of trial date
    02 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-366-1160
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02345226
    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, Inc., GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, Inc., GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 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 non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC 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
    Canada: 44
    Country: Number of subjects enrolled
    Puerto Rico: 18
    Country: Number of subjects enrolled
    Switzerland: 11
    Country: Number of subjects enrolled
    United States: 683
    Country: Number of subjects enrolled
    Spain: 29
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    France: 13
    Country: Number of subjects enrolled
    Germany: 60
    Worldwide total number of subjects
    881
    EEA total number of subjects
    125
    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)
    849
    From 65 to 84 years
    32
    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 02 January 2019.

    Pre-assignment
    Screening details
    		 974 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 + EFV/FTC/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
    Efavirenz/Emtricitabine/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
    		 EFV/FTC/TDF
    Arm description
    		 Double-Blind Phase: EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo to match FTC/RPV/TAF tablet orally once daily for up to 96 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate
    Investigational medicinal product code
    Other name
    EFV/FTC/TDF, Atripla®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600/200/300 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 EFV/FTC/TDF
    Started
    438
    437
    Completed
    371
    370
    Not completed
    67
    67
         Withdrew Consent
    41
    39
         Adverse Event
    5
    6
         Non-Compliance with Study Drug
    1
    2
         Death
    3
    -
         Investigator's Discretion
    4
    3
         Pregnancy
    -
    1
         Lost to follow-up
    12
    16
         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: 6 participants (FTC/RPV/TAF: N= 2; EFV/FTC/TDF; N= 4) 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 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

    Arm title
    		 EFV/FTC/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 EFV/FTC/TDF To FTC/RPV/TAF
    Started
    25
    21
    Completed
    25
    20
    Not completed
    0
    1
         Lost to follow-up
    -
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 695 participants (FTC/RPV/TAF: N = 346; EFV/FTC/TDF: N = 349) 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 + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.

    Reporting group title
    EFV/FTC/TDF
    Reporting group description
    		 Double-Blind Phase: EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo to match FTC/RPV/TAF tablet orally once daily for up to 96 weeks.

    Reporting group values
    		 FTC/RPV/TAF EFV/FTC/TDF Total
    Number of subjects
    		 438 437 875
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48 ( 9.8 ) 47 ( 10.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 373 390 763
        Male
    		 65 47 112
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 3 2 5
        Asian
    		 9 8 17
        Black
    		 118 120 238
        Native Hawaiian or Pacific Islander
    		 1 0 1
        White
    		 291 292 583
        Not Permitted
    		 6 3 9
        Other
    		 10 12 22
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 79 78 157
        Not Hispanic or Latino
    		 358 359 717
        Not Permitted
    		 1 0 1
    HIV-1 RNA Category
    Units: Subjects
        < 50 copies/mL
    		 430 432 862
        ≥ 50 copies/mL
    		 8 5 13
    CD4 Cell Count Category
    Units: Subjects
        ≥ 50 to < 200 cells/μL
    		 2 5 7
        ≥ 200 to < 350 cells/μL
    		 41 26 67
        ≥ 350 to < 500 cells/μL
    		 63 74 137
        ≥ 500 cells/ μL
    		 332 332 664
    CD4 Cell Count
    Units: cells/μL
        arithmetic mean (standard deviation)
    		 711 ( 292.3 ) 688 ( 263.5 ) -

    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 + EFV/FTC/TDF placebo tablet orally once daily for up to 96 weeks.

    Reporting group title
    EFV/FTC/TDF
    Reporting group description
    		 Double-Blind Phase: EFV/FTC/TDF (600/200/300 mg) FDC tablet + FTC/RPV/TAF placebo to match FTC/RPV/TAF 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 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.

    Reporting group title
    EFV/FTC/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 EFV/FTC/TDF prior to the screening visit.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 FTC/RPV/TAF EFV/FTC/TDF
    Number of subjects analysed
    438
    437
    Units: percentage of participants
        number (not applicable)
    90.0
    92.0
    Statistical analysis title
    		 Statistical Analysis 1- FTC/RPV/TAF vs EFV/FTC/TDF
    Statistical analysis description
    The null hypothesis was that the percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 in the FTC/RPV/TAF group was at least 8% lower than the rate in the EFV/FTC/TDF group; the 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 the EFV/FTC/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 EFV/FTC/TDF
    Number of subjects included in analysis
    875
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in Percentages
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.9
         upper limit
    		 1.8
    Notes
    [1] - A sample size of 400 HIV-1 infected participants per treatment group would provide 95% power to detect a non-inferiority margin of 8% in the Week 48 response rate difference between the FTC/RPV/TAF group and EFV/FTC/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 EFV/FTC/TDF
    Comparison groups
    FTC/RPV/TAF v EFV/FTC/TDF
    Number of subjects included in analysis
    875
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.35
    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 EFV/FTC/TDF
    Number of subjects analysed
    438
    437
    Units: percentage of participants
        number (not applicable)
    1.1
    0.9
    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 anallowed 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 EFV/FTC/TDF
    Number of subjects analysed
    438
    437
    Units: percentage of participants
        number (not applicable)
    0.7
    0.9
    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

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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
    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 EFV/FTC/TDF
    Number of subjects analysed
    438
    437
    Units: percentage of participants
        number (not applicable)
    85.2
    85.1
    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 EFV/FTC/TDF
    Number of subjects analysed
    390
    403
    Units: cells/μL
        arithmetic mean (standard deviation)
    23 ( 156.4 )
    12 ( 153.3 )
    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 EFV/FTC/TDF
    Number of subjects analysed
    370
    371
    Units: cells/μL
        arithmetic mean (standard deviation)
    12 ( 199.8 )
    6 ( 153.2 )
    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 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 EFV/FTC/TDF
    Number of subjects analysed
    347
    367
    Units: percentage change
        arithmetic mean (standard deviation)
    1.279 ( 2.3800 )
    -0.134 ( 2.4930 )
    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
    End point type
    Secondary
    End point timeframe
    Hip BMD was assessed by DXA scan. Participants in the Hip DXA Analysis Set with available data were analyzed.
    End point values
    		 FTC/RPV/TAF EFV/FTC/TDF
    Number of subjects analysed
    322
    345
    Units: percentage change
        arithmetic mean (standard deviation)
    1.831 ( 3.2925 )
    -0.617 ( 3.3046 )
    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, received at least 1 dose of study drug, and had nonmissing baseline spine BMD values) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 FTC/RPV/TAF EFV/FTC/TDF
    Number of subjects analysed
    351
    369
    Units: percentage change
        arithmetic mean (standard deviation)
    1.645 ( 3.3198 )
    -0.045 ( 2.9087 )
    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
    End point type
    Secondary
    End point timeframe
    Spine BMD was assessed by DXA scan. Participants in the Spine DXA Analysis Set with available data were analyzed.
    End point values
    		 FTC/RPV/TAF EFV/FTC/TDF
    Number of subjects analysed
    327
    344
    Units: percentage change
        arithmetic mean (standard deviation)
    1.701 ( 3.6185 )
    0.126 ( 3.2400 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48

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    End point title
    		 Change From Baseline in HIV Symptoms Index Score (HIVSI) at Week 48
    End point description
    The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don’t have this symptom; 1 = It doesn’t bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing. Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 FTC/RPV/TAF EFV/FTC/TDF
    Number of subjects analysed
    368
    383
    Units: units on a scale
        arithmetic mean (standard deviation)
    0 ( 3.4 )
    -1 ( 3.4 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in HIVSI Score at Week 96

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    End point title
    		 Change From Baseline in HIVSI Score at Week 96
    End point description
    The HIV Symptoms Index was a 20-item, self-reported measure that addressed presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Twenty HIV symptoms including Fatigue, Fever, Dizziness, Hand/Foot Pain, Memory Loss, Nausea, Diarrhea, Sadness, Nervous/anxious, Sleep Trouble, Skin Problems, Cough, Headache, Appetite Loss, Stomach Pain, Muscle/Joint Pain, Sex Problems, Change in Fat Deposits, Weight Loss, and Hair Loss were assessed. There were 5 possible responses (0 = I don’t have this symptom; 1 = It doesn’t bother me; 2 = It bothers me a little; 3 = It bothers me; and 4 = It bothers me a lot) for each HIV symptom. Total HIV Symptoms Index Score was derived from all 20 HIV symptoms by counting the number of bothersome symptoms. Total score would be missing if any of the individual items were missing. Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 96
    End point values
    		 FTC/RPV/TAF EFV/FTC/TDF
    Number of subjects analysed
    347
    347
    Units: units on a scale
        arithmetic mean (standard deviation)
    0 ( 4.1 )
    -1 ( 3.3 )
    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: 172.4 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 EFV/FTC/TDF placebo tablet administered orally once daily.

    Reporting group title
    EFV/FTC/TDF (Double-Blind Phase)
    Reporting group description
    		 Adverse events reported occurred during the Double-Blind Phase in participants from the EFV/FTC/TDF group, who received EFV/FTC/TDF (600/200/300 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 EFV/FTC/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 EFV/FTC/TDF group and received FTC/RPV/TAF (200/25/25 mg) FDC tablet once daily.

    Serious adverse events
    		 FTC/RPV/TAF (Double-Blind Phase) EFV/FTC/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From EFV/FTC/TDF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    54 / 438 (12.33%)
    45 / 437 (10.30%)
    0 / 25 (0.00%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    3
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    2 / 438 (0.46%)
    3 / 437 (0.69%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenosquamous cell lung cancer
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Bronchial carcinoma
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Laryngeal papilloma
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Lymphoma
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Metastases to bone
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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-small cell lung cancer stage IV
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Circulatory collapse
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Deep vein thrombosis
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Peripheral artery aneurysm
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Surgical and medical procedures
    Ileostomy closure
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Knee arthroplasty
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Chest pain
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Pyrexia
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 438 (0.23%)
    3 / 437 (0.69%)
    0 / 25 (0.00%)
    0 / 21 (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
    Pulmonary embolism
         subjects affected / exposed
    4 / 438 (0.91%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 438 (0.46%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Pleuritic pain
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary infarction
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Respiratory failure
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Suicide attempt
         subjects affected / exposed
    1 / 438 (0.23%)
    2 / 437 (0.46%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 438 (0.23%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Alcohol abuse
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Bipolar II disorder
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Drug abuse
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Mental status changes
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 438 (0.23%)
    2 / 437 (0.46%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Clavicle fracture
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Fibula fracture
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Foot fracture
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Limb fracture
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Limb injury
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Multiple fractures
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Post procedural complication
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Road traffic accident
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Tibia fracture
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Atrial fibrillation
         subjects affected / exposed
    1 / 438 (0.23%)
    2 / 437 (0.46%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    2 / 438 (0.46%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Myocardial infarction
         subjects affected / exposed
    2 / 438 (0.46%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Angina pectoris
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Pericarditis
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Sinus tachycardia
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 438 (0.23%)
    2 / 437 (0.46%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 438 (0.23%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Aphasia
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Ataxia
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Carotid artery stenosis
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Dizziness
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Haemorrhagic anaemia
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 438 (0.46%)
    3 / 437 (0.69%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 438 (0.23%)
    2 / 437 (0.46%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    2 / 438 (0.46%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Anal stenosis
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Diarrhoea
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Incarcerated inguinal hernia
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Oesophageal ulcer
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Rectal perforation
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Vomiting
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Cholelithiasis
         subjects affected / exposed
    2 / 438 (0.46%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Cholecystitis
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 438 (0.00%)
    3 / 437 (0.69%)
    0 / 25 (0.00%)
    0 / 21 (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
    Fanconi syndrome acquired
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    1 / 438 (0.23%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Pathological fracture
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    5 / 438 (1.14%)
    3 / 437 (0.69%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    3 / 438 (0.68%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 438 (0.00%)
    2 / 437 (0.46%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 438 (0.00%)
    2 / 437 (0.46%)
    0 / 25 (0.00%)
    0 / 21 (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
    Diarrhoea infectious
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    2 / 438 (0.46%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Localised infection
         subjects affected / exposed
    1 / 438 (0.23%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Osteomyelitis
         subjects affected / exposed
    0 / 438 (0.00%)
    2 / 437 (0.46%)
    0 / 25 (0.00%)
    0 / 21 (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
    Sepsis
         subjects affected / exposed
    2 / 438 (0.46%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Abdominal abscess
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Abscess
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Bacterial parotitis
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Cellulitis orbital
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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 salmonella
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis shigella
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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 infection
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Infectious colitis
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Perineal abscess
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Scrotal infection
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Stoma site abscess
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Urinary tract infection
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Hypercalcaemia
         subjects affected / exposed
    1 / 438 (0.23%)
    0 / 437 (0.00%)
    0 / 25 (0.00%)
    0 / 21 (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
    Metabolic acidosis
         subjects affected / exposed
    0 / 438 (0.00%)
    1 / 437 (0.23%)
    0 / 25 (0.00%)
    0 / 21 (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) EFV/FTC/TDF (Double-Blind Phase) Open-Label FTC/RPV/TAF From FTC/RPV/TAF Open-Label FTC/RPV/TAF From EFV/FTC/TDF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    277 / 438 (63.24%)
    270 / 437 (61.78%)
    13 / 25 (52.00%)
    9 / 21 (42.86%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    25 / 438 (5.71%)
    16 / 437 (3.66%)
    1 / 25 (4.00%)
    0 / 21 (0.00%)
         occurrences all number
    25
    16
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    35 / 438 (7.99%)
    31 / 437 (7.09%)
    1 / 25 (4.00%)
    0 / 21 (0.00%)
         occurrences all number
    41
    38
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    41 / 438 (9.36%)
    47 / 437 (10.76%)
    1 / 25 (4.00%)
    2 / 21 (9.52%)
         occurrences all number
    44
    54
    1
    2
    Nausea
         subjects affected / exposed
    23 / 438 (5.25%)
    16 / 437 (3.66%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    25
    17
    0
    0
    Abdominal pain
         subjects affected / exposed
    22 / 438 (5.02%)
    13 / 437 (2.97%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    22
    13
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    45 / 438 (10.27%)
    30 / 437 (6.86%)
    2 / 25 (8.00%)
    2 / 21 (9.52%)
         occurrences all number
    52
    32
    2
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    24 / 438 (5.48%)
    16 / 437 (3.66%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    25
    16
    0
    0
    Eczema
         subjects affected / exposed
    4 / 438 (0.91%)
    2 / 437 (0.46%)
    0 / 25 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    4
    2
    0
    2
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    26 / 438 (5.94%)
    23 / 437 (5.26%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    26
    23
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    34 / 438 (7.76%)
    42 / 437 (9.61%)
    0 / 25 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    36
    43
    0
    3
    Back pain
         subjects affected / exposed
    35 / 438 (7.99%)
    37 / 437 (8.47%)
    1 / 25 (4.00%)
    0 / 21 (0.00%)
         occurrences all number
    37
    41
    1
    0
    Pain in extremity
         subjects affected / exposed
    28 / 438 (6.39%)
    15 / 437 (3.43%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    29
    18
    0
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    74 / 438 (16.89%)
    70 / 437 (16.02%)
    1 / 25 (4.00%)
    1 / 21 (4.76%)
         occurrences all number
    107
    96
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    51 / 438 (11.64%)
    39 / 437 (8.92%)
    3 / 25 (12.00%)
    1 / 21 (4.76%)
         occurrences all number
    67
    58
    3
    1
    Syphilis
         subjects affected / exposed
    39 / 438 (8.90%)
    31 / 437 (7.09%)
    0 / 25 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    45
    39
    0
    2
    Sinusitis
         subjects affected / exposed
    23 / 438 (5.25%)
    32 / 437 (7.32%)
    1 / 25 (4.00%)
    0 / 21 (0.00%)
         occurrences all number
    30
    38
    1
    0
    Bronchitis
         subjects affected / exposed
    24 / 438 (5.48%)
    28 / 437 (6.41%)
    2 / 25 (8.00%)
    0 / 21 (0.00%)
         occurrences all number
    29
    34
    2
    0
    Pharyngitis
         subjects affected / exposed
    12 / 438 (2.74%)
    19 / 437 (4.35%)
    2 / 25 (8.00%)
    1 / 21 (4.76%)
         occurrences all number
    12
    20
    2
    1
    Urinary tract infection
         subjects affected / exposed
    22 / 438 (5.02%)
    7 / 437 (1.60%)
    0 / 25 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    27
    9
    0
    0
    Rhinitis
         subjects affected / exposed
    5 / 438 (1.14%)
    7 / 437 (1.60%)
    4 / 25 (16.00%)
    0 / 21 (0.00%)
         occurrences all number
    11
    8
    4
    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. • The inclusion criterion relating to women of nonchildbearing potential was corrected. • 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.
    13 Apr 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 ATR 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.
    19 Mar 2018
    • Updated Study Design, Study Procedures/Frequency, and Duration of Treatment to include extension of open-label FTC/RPV/TAF FDC availability post Open-Label Week 48 for countries where FTC/RPV/TAF FDC is not yet commercially available. • Safety of TAF for bone mineral density is well established. Continuing. DXA exams in open-label phase would not provide a significant safety benefit so Bone evaluation was updated to clarify that DXA scans are not required after Open-Label Week 24 visit.

    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/28259776
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