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    Clinical Trial Results:
    A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults

    Summary
    EudraCT number
    		 2010-024007-27
    Trial protocol
    		 GB   DE   PT   BE   ES   AT   IT  
    Global end of trial date
    03 Feb 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Mar 2016
    First version publication date
    06 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-264-0110
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01309243
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences, Inc.
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@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
    03 Feb 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Feb 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of the study was to evaluate the safety and efficacy of the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously received treatment with antiretroviral medications. Participants were randomized in a 1:1 ratio to receive one of the study treatments. Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. A treatment duration of 96 weeks was planned, with the option for subjects in FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is commercially available or until Gilead Sciences elects to terminate development in that country.
    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
    02 Feb 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Portugal: 7
    Country: Number of subjects enrolled
    Spain: 15
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Austria: 13
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    France: 23
    Country: Number of subjects enrolled
    Germany: 47
    Country: Number of subjects enrolled
    Italy: 13
    Country: Number of subjects enrolled
    United States: 541
    Country: Number of subjects enrolled
    Canada: 48
    Country: Number of subjects enrolled
    Australia: 40
    Country: Number of subjects enrolled
    Puerto Rico: 18
    Country: Number of subjects enrolled
    Switzerland: 5
    Worldwide total number of subjects
    799
    EEA total number of subjects
    147
    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)
    792
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects were enrolled in a total of 121 study sites in North America, Europe, and Australia. The first participant was screened on 23 February 2011. The last participant observation was on 03 February 2014.

    Pre-assignment
    Screening details
    		 991 participants were screened.

    Period 1
    Period 1 title
    Randomized Phase through Week 96
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FTC/RPV/TDF
    Arm description
    		 FTC/RPV/TDF STR administered orally once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    FTC/RPV/TDF
    Investigational medicinal product code
    Other name
    Eviplera®, Complera®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily

    Arm title
    		 EFV/FTC/TDF
    Arm description
    		 EFV/TFC/TDF STR administered orally once daily
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EFV/FTC/TDF
    Investigational medicinal product code
    Other name
    Atripla®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg STR administered orally once daily

    Number of subjects in period 1 [1]
    		FTC/RPV/TDF EFV/FTC/TDF
    Started
    394
    392
    Randomized and Treated
    394
    392
    Completed
    325
    313
    Not completed
    69
    79
         Adverse event, serious fatal
    -
    1
         Adverse event, non-fatal
    7
    17
         Death
    -
    1
         Investigators Discretion
    5
    6
         Protocol Violation
    1
    -
         Lost to follow-up
    25
    26
         Withdrew consent
    15
    22
         Participant noncompliance
    7
    5
         Lack of efficacy
    9
    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: 13 participants who were enrolled but not treated are not included in the subject disposition table.
    Period 2
    Period 2 title
    Extension Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FTC/RPV/TDF
    Arm description
    		 FTC/RPV/TDF STR administered orally once daily
    Arm type
    		 Experimental

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

    Arm title
    		 EFV/FTC/TDF
    Arm description
    		 EFV/FTC/TDF STR administered orally once daily
    Arm type
    		 Active comparator

    Investigational medicinal product name
    EFV/FTC/TDF
    Investigational medicinal product code
    Other name
    Atripla®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily

    Number of subjects in period 2 [2]
    		FTC/RPV/TDF EFV/FTC/TDF
    Started
    40
    117
    Completed
    34
    117
    Not completed
    6
    0
         Lost to follow-up
    6
    -
    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: Of those who completed the Randomized Phase (FTC/RPV/TDF: n = 316; EFV/FTC/TDF: n = 290), 40 participants randomized to FTC/RPV/TDF and 117 participants randomized to EFV/FTC/TDF entered the Extension Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FTC/RPV/TDF
    Reporting group description
    		 FTC/RPV/TDF STR administered orally once daily

    Reporting group title
    EFV/FTC/TDF
    Reporting group description
    		 EFV/TFC/TDF STR administered orally once daily

    Reporting group values
    		 FTC/RPV/TDF EFV/FTC/TDF Total
    Number of subjects
    		 394 392 786
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37 ± 10.4 37 ± 11 -
    Gender, Male/Female
    Units: participants
        Female
    		 28 28 56
        Male
    		 366 364 730
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 3 1 4
        Asian
    		 8 13 21
        Black or African Heritage
    		 98 94 192
        Native Hawaiian or Pacific Islander
    		 4 3 7
        White
    		 266 262 528
        Other
    		 13 19 32
        Not Permitted
    		 1 0 1
        Not Reported
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 59 75 134
        Non-Hispanic/Latino
    		 331 315 646
        Not Permitted
    		 3 2 5
        Not Reported
    		 1 0 1
    HIV-1 RNA Category
    Units: Subjects
        ≤ 100,000 copies/mL
    		 260 250 510
        > 100,000 copies/mL
    		 134 142 276
    Use of lipid-lowering agent
    Units: Subjects
        Yes
    		 4 1 5
        No
    		 390 391 781
    HIV-1 RNA
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    		 4.8 ± 0.65 4.8 ± 0.61 -
    Cluster of differentiation 4 (CD4) Cell Count
    Units: cells/μL
        arithmetic mean (standard deviation)
    		 395.7 ± 179.64 385.2 ± 186.82 -

    End points

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    End points reporting groups
    Reporting group title
    FTC/RPV/TDF
    Reporting group description
    		 FTC/RPV/TDF STR administered orally once daily

    Reporting group title
    EFV/FTC/TDF
    Reporting group description
    		 EFV/TFC/TDF STR administered orally once daily
    Reporting group title
    FTC/RPV/TDF
    Reporting group description
    		 FTC/RPV/TDF STR administered orally once daily

    Reporting group title
    EFV/FTC/TDF
    Reporting group description
    		 EFV/FTC/TDF STR administered orally once daily

    Primary: Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48

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    End point title
    		 Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm. The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time. Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 FTC/RPV/TDF EFV/FTC/TDF
    Number of subjects analysed
    394
    392
    Units: percentage of participants
        number (not applicable)
    85.8
    81.6
    Statistical analysis title
    		 Difference in percentage
    Statistical analysis description
    The analysis was to assess the noninferiority of FTC/RPV/TDF versus EFV/FTC/TDF using a 95% confidence interval (CI) approach, with a noninferiority margin of 12% (lower bound of CI > -12%). 700 subjects allocated 1:1 to either treatment arm was predicted to give > 95% power when the proportion of responders in both treatment groups for the primary endpoint is 80% at Week 48.
    Comparison groups
    FTC/RPV/TDF v EFV/FTC/TDF
    Number of subjects included in analysis
    786
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in the response rates
    Point estimate
    4.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 9.2
    Notes
    [1] - Null hypothesis: The FTC/RPV/TDF group was at least 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA < 50 copies/mL (“response rate,” as defined by the snapshot analysis algorithm) at Week 48. Alternative hypothesis: The FTC/RPV/TDF group was less than 12% worse than the EFV/FTC/TDF group with respect to the percentage of subjects achieving HIV-1 RNA 50 copies/mL at Week 48.

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the US FDA snapshot algorithm. Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Baseline to Week 96
    End point values
    		 FTC/RPV/TDF EFV/FTC/TDF
    Number of subjects analysed
    394
    392
    Units: percentage of participants
        number (not applicable)
    77.9
    72.4
    Statistical analysis title
    		 Difference in percentage
    Comparison groups
    FTC/RPV/TDF v EFV/FTC/TDF
    Number of subjects included in analysis
    786
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    Method
    Parameter type
    		 Difference in the response rates
    Point estimate
    5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.6
         upper limit
    		 11.5
    Notes
    [2] - Comparative analysis

    Secondary: Change from baseline in CD4 cell count at Week 48

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    End point title
    		 Change from baseline in CD4 cell count at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    		 FTC/RPV/TDF EFV/FTC/TDF
    Number of subjects analysed
    357
    346
    Units: cells/μL
        arithmetic mean (standard deviation)
    200 ± 158.6
    191 ± 144.3
    Statistical analysis title
    		 Difference in change from baseline
    Comparison groups
    FTC/RPV/TDF v EFV/FTC/TDF
    Number of subjects included in analysis
    703
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.34 [4]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11
         upper limit
    		 32
    Notes
    [3] - Comparative analysis
    [4] - The p-value, and difference in least square means (LSM) and its 95% CI are from analysis of variance (ANOVA) with treatment and baseline HIV-1 RNA levels (≤ 100,000, > 100,000 copies/mL) as fixed effect.

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

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    End point title
    		 Change From Baseline in CD4 Cell Count at Week 96
    End point description
    Participants in the Full Analysis Set with available data were analyzed; the missing = excluded method was used in which all participants with missing data were excluded from analysis.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 96
    End point values
    		 FTC/RPV/TDF EFV/FTC/TDF
    Number of subjects analysed
    327
    319
    Units: cells/μL
        arithmetic mean (standard deviation)
    278 ± 186.6
    259 ± 191.4
    Statistical analysis title
    		 STATISTICAL_ANALYSIS_TITLE
    Comparison groups
    FTC/RPV/TDF v EFV/FTC/TDF
    Number of subjects included in analysis
    646
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.17 [6]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    20
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 49
    Notes
    [5] - Comparative analysis
    [6] - The p-value, and difference in LSM and its 95% CI are from ANOVA with treatment and baseline HIV-1 RNA levels (≤ 100,000, > 100,000 copies/mL) as fixed effect.

    Secondary: Change from baseline in Fasting Total Cholesterol at Week 48

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    End point title
    		 Change from baseline in Fasting Total Cholesterol at Week 48
    End point description
    Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    		 FTC/RPV/TDF EFV/FTC/TDF
    Number of subjects analysed
    322
    305
    Units: mg/dL
        arithmetic mean (standard deviation)
    1 ± 28.1
    22 ± 31.3
    Statistical analysis title
    		 Difference in change from baseline
    Comparison groups
    FTC/RPV/TDF v EFV/FTC/TDF
    Number of subjects included in analysis
    627
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 < 0.001 [8]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [7] - Comparative analysis
    [8] - P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.

    Secondary: Change from baseline in Fasting high-density lipoprotein (HDL) Cholesterol at Week 48

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    End point title
    		 Change from baseline in Fasting high-density lipoprotein (HDL) Cholesterol at Week 48
    End point description
    Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    		 FTC/RPV/TDF EFV/FTC/TDF
    Number of subjects analysed
    322
    305
    Units: mg/dL
        arithmetic mean (standard deviation)
    2 ± 8.7
    8 ± 10.3
    Statistical analysis title
    		 Difference in change from baseline
    Comparison groups
    FTC/RPV/TDF v EFV/FTC/TDF
    Number of subjects included in analysis
    627
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 < 0.001 [10]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [9] - Comparative analysis
    [10] - P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.

    Secondary: Change from baseline in Fasting low-density lipoprotein (LDL) Cholesterol at Week 48

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    End point title
    		 Change from baseline in Fasting low-density lipoprotein (LDL) Cholesterol at Week 48
    End point description
    Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    		 FTC/RPV/TDF EFV/FTC/TDF
    Number of subjects analysed
    322
    303
    Units: mg/dL
        arithmetic mean (standard deviation)
    1 ± 24.4
    14 ± 28.2
    Statistical analysis title
    		 Difference in change from baseline
    Comparison groups
    FTC/RPV/TDF v EFV/FTC/TDF
    Number of subjects included in analysis
    625
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 < 0.001 [12]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [11] - Comparative analysis
    [12] - P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.

    Secondary: Change from baseline in Fasting triglycerides at Week 48

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    End point title
    		 Change from baseline in Fasting triglycerides at Week 48
    End point description
    Participants in the Safety Analysis Set with available data were analyzed using the missing = excluded method.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 48
    End point values
    		 FTC/RPV/TDF EFV/FTC/TDF
    Number of subjects analysed
    322
    305
    Units: mg/dL
        arithmetic mean (standard deviation)
    -8 ± 68.9
    8 ± 103
    Statistical analysis title
    		 Difference in change from baseline
    Comparison groups
    EFV/FTC/TDF v FTC/RPV/TDF
    Number of subjects included in analysis
    627
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 < 0.001 [14]
    Method
    		 ANOVA
    Confidence interval
    Notes
    [13] - Comparative analysis
    [14] - P-value for the difference in change from baseline at Week 48 is from ANOVA with treatment as fixed effect.

    Secondary: Development of HIV-1 Drug Resistance through Week 96, All Participants

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    End point title
    		 Development of HIV-1 Drug Resistance through Week 96, All Participants
    End point description
    Full Analysis Set: participants with either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed for resistance. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥50 copies/mL and <1 log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥400 copies/mL after achieving HIV-1 RNA <50 copies/mL, or as having 2 consecutive visits with >1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis
    End point type
    Secondary
    End point timeframe
    Baseline to Week 96
    End point values
    		 FTC/RPV/TDF EFV/FTC/TDF
    Number of subjects analysed
    394
    392
    Units: percentage of participants
    number (not applicable)
        Baseline through Week 48
    4.3
    0.8
        Week 48 through Week 96
    1
    0.3
        Baseline through Week 96
    5.3
    1
    No statistical analyses for this end point

    Secondary: Development of HIV-1 Drug Resistance through Week 96, Participants with Viral Resistance

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    End point title
    		 Development of HIV-1 Drug Resistance through Week 96, Participants with Viral Resistance
    End point description
    Resistance Analysis Set: participants with either suboptimal virologic response or virologic rebound were considered to have virologic failure and were analyzed. Suboptimal virologic response was assessed at Week 8 and was defined as having HIV-1 RNA ≥50 copies/mL and <1 log10 reduction from baseline at the Week 8 visit, which was confirmed at the subsequent visit. Virologic rebound was defined as having 2 consecutive visits with HIV-1 RNA ≥400 copies/mL after achieving HIV-1 RNA <50 copies/mL, or as having 2 consecutive visits with >1 log10 increase in HIV-1 RNA from their nadir. In addition, subjects who were on study drugs, had not been analyzed previously, and who had HIV-1 RNA ≥400 copies/mL at Week 48, Week 96, or their last visit (at or after Week 8) were also analyzed for resistance at their last visit. Subsequent to the first resistance testing, subjects experiencing repeated confirmed virologic failure were assessed for resistance retesting on a case-by-case basis.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 96
    End point values
    		 FTC/RPV/TDF EFV/FTC/TDF
    Number of subjects analysed
    24
    9
    Units: participants
    number (not applicable)
        Baseline through Week 48
    17
    3
        Week 48 through Week 96
    4
    1
        Baseline through Week 96
    21
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through Week 96 (Randomized Phase), and Week 96 up to a maximum of 954 days (Extension Phase)
    Adverse event reporting additional description
    Safety Analysis Set: 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
    16.1
    Reporting groups
    Reporting group title
    FTC/RPV/TDF
    Reporting group description
    		 FTC/RPV/TDF STR administered orally once daily

    Reporting group title
    EFV/FTC/TDF
    Reporting group description
    		 EFV/FTC/TDF STR administered orally once daily

    Serious adverse events
    		 FTC/RPV/TDF EFV/FTC/TDF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 394 (9.14%)
    48 / 392 (12.24%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Burkitt's lymphoma
         subjects affected / exposed
    1 / 394 (0.25%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal squamous cell carcinoma
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anogenital warts
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniopharyngioma
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gliosarcoma
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer stage 0
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular germ cell cancer
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Behcet's syndrome
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 394 (0.51%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 394 (0.00%)
    2 / 392 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Cervical dysplasia
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asphyxia
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epistaxis
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 394 (0.51%)
    2 / 392 (0.51%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 394 (0.25%)
    3 / 392 (0.77%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    2 / 394 (0.51%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    2 / 394 (0.51%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    1 / 394 (0.25%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Delirium tremens
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    2 / 394 (0.51%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    1 / 394 (0.25%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 394 (0.00%)
    2 / 392 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 394 (0.25%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 394 (0.25%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Haemolytic anaemia
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Rectal haemorrhage
         subjects affected / exposed
    0 / 394 (0.00%)
    2 / 392 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Leukocytoclastic vasculitis
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    2 / 394 (0.51%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis reactive
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    2 / 394 (0.51%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 394 (0.25%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 394 (0.25%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurosyphilis
         subjects affected / exposed
    0 / 394 (0.00%)
    2 / 392 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    1 / 394 (0.25%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye infection syphilitic
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis shigella
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secondary syphilis
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 394 (0.25%)
    0 / 392 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 394 (0.00%)
    1 / 392 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 FTC/RPV/TDF EFV/FTC/TDF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    300 / 394 (76.14%)
    322 / 392 (82.14%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    27 / 394 (6.85%)
    90 / 392 (22.96%)
         occurrences all number
    30
    93
    Headache
         subjects affected / exposed
    56 / 394 (14.21%)
    61 / 392 (15.56%)
         occurrences all number
    64
    67
    Somnolence
         subjects affected / exposed
    9 / 394 (2.28%)
    30 / 392 (7.65%)
         occurrences all number
    9
    30
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    42 / 394 (10.66%)
    54 / 392 (13.78%)
         occurrences all number
    45
    58
    Pyrexia
         subjects affected / exposed
    16 / 394 (4.06%)
    22 / 392 (5.61%)
         occurrences all number
    19
    22
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    69 / 394 (17.51%)
    78 / 392 (19.90%)
         occurrences all number
    83
    89
    Nausea
         subjects affected / exposed
    65 / 394 (16.50%)
    65 / 392 (16.58%)
         occurrences all number
    71
    70
    Vomiting
         subjects affected / exposed
    20 / 394 (5.08%)
    21 / 392 (5.36%)
         occurrences all number
    23
    27
    Flatulence
         subjects affected / exposed
    24 / 394 (6.09%)
    9 / 392 (2.30%)
         occurrences all number
    25
    9
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    38 / 394 (9.64%)
    27 / 392 (6.89%)
         occurrences all number
    42
    28
    Oropharyngeal pain
         subjects affected / exposed
    23 / 394 (5.84%)
    15 / 392 (3.83%)
         occurrences all number
    29
    17
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    31 / 394 (7.87%)
    51 / 392 (13.01%)
         occurrences all number
    33
    55
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    23 / 394 (5.84%)
    101 / 392 (25.77%)
         occurrences all number
    23
    104
    Insomnia
         subjects affected / exposed
    45 / 394 (11.42%)
    60 / 392 (15.31%)
         occurrences all number
    46
    68
    Depression
         subjects affected / exposed
    34 / 394 (8.63%)
    47 / 392 (11.99%)
         occurrences all number
    34
    50
    Anxiety
         subjects affected / exposed
    28 / 394 (7.11%)
    37 / 392 (9.44%)
         occurrences all number
    29
    37
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    28 / 394 (7.11%)
    23 / 392 (5.87%)
         occurrences all number
    29
    25
    Back pain
         subjects affected / exposed
    20 / 394 (5.08%)
    25 / 392 (6.38%)
         occurrences all number
    22
    27
    Myalgia
         subjects affected / exposed
    20 / 394 (5.08%)
    13 / 392 (3.32%)
         occurrences all number
    21
    14
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    57 / 394 (14.47%)
    72 / 392 (18.37%)
         occurrences all number
    75
    98
    Nasopharyngitis
         subjects affected / exposed
    33 / 394 (8.38%)
    39 / 392 (9.95%)
         occurrences all number
    46
    49
    Bronchitis
         subjects affected / exposed
    34 / 394 (8.63%)
    29 / 392 (7.40%)
         occurrences all number
    37
    38
    Sinusitis
         subjects affected / exposed
    28 / 394 (7.11%)
    19 / 392 (4.85%)
         occurrences all number
    34
    21
    Syphilis
         subjects affected / exposed
    26 / 394 (6.60%)
    18 / 392 (4.59%)
         occurrences all number
    29
    20
    Folliculitis
         subjects affected / exposed
    27 / 394 (6.85%)
    8 / 392 (2.04%)
         occurrences all number
    28
    8
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    10 / 394 (2.54%)
    20 / 392 (5.10%)
         occurrences all number
    10
    20

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Nov 2010
    The use of HIV Treatment Satisfaction Questionnaire (HIVTSQ[c]) was changed to HIVTSQ(s), and HIVTSQ(s) was removed from the Screening Visit since the subjects in this study were ARV treatment naive; inclusion criteria were revised so that subjects who had received the Gilead Sciences investigational product tenofovir alafenamide (TAF; formerly known as GS-7340) and participated in Gilead Study GS-US-120-0104 were no longer eligible for the study; management of suboptimal virologic response was clarified.
    05 Apr 2011
    Inclusion of food examples to ensure proper dosing of FTC/RPV/TDF STR; removal of ‘life expectancy ≥ 1 year’ and allowance of pre-exposure prophylaxis (PrEP) from the inclusion criteria; removal of ‘history of liver disease including Gilbert’s Disease’ from the exclusion criteria.

    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.
    There were no limitations affecting the analysis or results.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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