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    Clinical Trial Results:
    A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Women

    Summary
    EudraCT number
    		 2012-003708-11
    Trial protocol
    		 BE   GB   PT   IT   FR  
    Global end of trial date
    06 Sep 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Sep 2019
    First version publication date
    22 Sep 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-236-0128
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01705574
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences , GileadClinicalTrials@gilead.com
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive , Foster City, CA , United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Sep 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy of a regimen containing Stribild® (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) fixed-dose combination (FDC) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus Truvada® (TVD; emtricitabine/tenofovir disoproxil fumarate; FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.
    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
    24 Oct 2012
    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
    Portugal: 21
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Puerto Rico: 3
    Country: Number of subjects enrolled
    Russian Federation: 194
    Country: Number of subjects enrolled
    Thailand: 24
    Country: Number of subjects enrolled
    Uganda: 163
    Country: Number of subjects enrolled
    Dominican Republic: 20
    Country: Number of subjects enrolled
    United States: 118
    Country: Number of subjects enrolled
    Mexico: 5
    Country: Number of subjects enrolled
    Belgium: 8
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Italy: 5
    Worldwide total number of subjects
    583
    EEA total number of subjects
    56
    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)
    582
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in North America, Europe, Dominican Republic, Thailand, and Uganda. The first participant was screened on 24 October 2012. The last study visit occurred on 06 September 2018.

    Pre-assignment
    Screening details
    		 810 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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Double-Blind STB
    Arm description
    		 Double-Blind (DB) Phase : STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Stribild® ; STB; E/C/F/TDF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150/150/200/300 mg FDC administered orally once daily with food

    Investigational medicinal product name
    Atazanavir placebo
    Investigational medicinal product code
    Other name
    ATV placebo
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsule orally once daily with food

    Investigational medicinal product name
    Ritonavir placebo
    Investigational medicinal product code
    Other name
    RTV placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet orally once daily with food

    Investigational medicinal product name
    Emtricitabine/tenofovir disoproxil fumarate placebo
    Investigational medicinal product code
    Other name
    FTC/TDF placebo; TVD placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet administered orally once daily with food

    Arm title
    		 Double-Blind ATV+RTV+TVD
    Arm description
    		 Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC + STB placebo orally once daily with food for 48 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz®; ATV
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg capsule administered orally once daily with food

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    RTV; Norvir®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg tablet orally once daily with food

    Investigational medicinal product name
    Emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    FTC/TDF; Truvada®; TVD
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/300 mg FDC tablet administered orally once daily with food

    Investigational medicinal product name
    Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate placebo
    Investigational medicinal product code
    Other name
    E/C/F/TDF placebo; STB placebo
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tablet orally once daily with food

    Number of subjects in period 1 [1]
    		Double-Blind STB Double-Blind ATV+RTV+TVD
    Started
    289
    286
    Completed
    260
    249
    Not completed
    29
    37
         Withdrew Consent
    8
    5
         Non-Compliance with Study Drug
    4
    5
         Adverse Event
    3
    10
         Pregnancy
    1
    1
         Protocol Violation
    1
    -
         Lost to follow-up
    12
    16
    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: 4 participants in each arm who were randomized but not treated are not included in the subject disposition table.
    Period 2
    Period 2 title
    Open-Label Extension (OLE) Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Double-Blind STB to Open-Label STB
    Arm description
    		 Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Stribild® ; STB; E/C/F/TDF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150/150/200/300 mg FDC administered orally once daily with food

    Arm title
    		 Double-Blind ATV+RTV +TVD to Open-Label GEN
    Arm description
    		 Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label Genvoya® (GEN; elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; E/C/F/TAF) 150/150/200/10 mg FDC orally once daily with food for 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir/ cobicistat/emtricitabine/tenofovir alafenamide
    Investigational medicinal product code
    Other name
    Genvoya®; GEN; E/C/F/TAF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150/150/200/10 mg FDC orally once daily with food

    Arm title
    		 Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD
    Arm description
    		 Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Reyataz®;ATV
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg capsule orally with food once daily

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Norvir®; RTV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg tablet orally with food once daily

    Investigational medicinal product name
    Emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    FTC/TDF;Truvada®; TVD
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/300 mg FDC tablet orally with food once daily

    Number of subjects in period 2 [2]
    		Double-Blind STB to Open-Label STB Double-Blind ATV+RTV +TVD to Open-Label GEN Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD
    Started
    246
    159
    53
    Completed
    231
    148
    48
    Not completed
    15
    11
    5
         Withdrew Consent
    4
    4
    1
         Physician decision
    -
    2
    -
         Non- Compliance with Study Drug
    -
    1
    -
         Adverse Event
    3
    -
    1
         Death
    2
    1
    -
         Pregnancy
    -
    1
    1
         Lost to follow-up
    6
    2
    2
    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: [1] Double-Blind STB to Open-Label STB arm: 14 participants did not enter the OLE STB arm. [2] Double-Blind ATV+RTV +TVD to Open-Label GEN: 159 participants entered from the DB ATV+RTV+TVD arm. [3]Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD: 53 participants entered from the DB ATV+ RTV + TVD arm.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Double-Blind STB
    Reporting group description
    		 Double-Blind (DB) Phase : STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks

    Reporting group title
    Double-Blind ATV+RTV+TVD
    Reporting group description
    		 Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC + STB placebo orally once daily with food for 48 weeks

    Reporting group values
    		 Double-Blind STB Double-Blind ATV+RTV+TVD Total
    Number of subjects
    		 289 286 575
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36 ± 10.1 36 ± 9.7 -
    Gender categorical
    Units: Subjects
        Female
    		 289 286 575
        Male
    		 0 0 0
    Race
    Units: Subjects
        Asian
    		 9 17 26
        Black
    		 143 133 276
        Native Hawaiian or Pacific Islander
    		 0 1 1
        White
    		 128 119 247
        Other
    		 9 15 24
        Not Permitted
    		 0 1 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 20 24 44
        Not Hispanic or Latino
    		 269 262 531
        Not Permitted
    		 0 0 0
    HIV-1 RNA Category
    Units: Subjects
        ≤ 100,000 copies/mL
    		 220 214 434
        > 100,000 to ≤400,000 copies/mL
    		 44 50 94
        > 400,000 copies/mL
    		 25 22 47
    CD4 Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    		 376 ± 199.6 385 ± 210.2 -

    End points

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    End points reporting groups
    Reporting group title
    Double-Blind STB
    Reporting group description
    		 Double-Blind (DB) Phase : STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks

    Reporting group title
    Double-Blind ATV+RTV+TVD
    Reporting group description
    		 Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC + STB placebo orally once daily with food for 48 weeks
    Reporting group title
    Double-Blind STB to Open-Label STB
    Reporting group description
    		 Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label STB FDC orally once daily with food for 48 weeks.

    Reporting group title
    Double-Blind ATV+RTV +TVD to Open-Label GEN
    Reporting group description
    		 Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label Genvoya® (GEN; elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide; E/C/F/TAF) 150/150/200/10 mg FDC orally once daily with food for 48 weeks.

    Reporting group title
    Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD
    Reporting group description
    		 Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD 200/300 mg FDC orally once daily with food for 48 weeks.

    Subject analysis set title
    ALL STB
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT Analysis Set included participants who were randomized into the study and received at least 1 dose of STB.

    Primary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 of the Double-Blind Phase as Determined 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 of the Double-Blind Phase as Determined by the US FDA-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the Intent-to-Treat (ITT) Analysis Set ( randomized and received at least one dose of study drug) were analyzed.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 Double-Blind STB Double-Blind ATV+RTV+TVD
    Number of subjects analysed
    289
    286
    Units: Years
        number (not applicable)
    87.2
    80.8
    Statistical analysis title
    		 HIV-1 RNA < 50 copies/mL– DB STB vs DB ATV+RTV+TVD
    Statistical analysis description
    The null hypothesis for non-inferiority was that the STB group was at least 12% worse than the ATV+RTV+TVD group with respect to the percentage of participants achieving HIV-1 RNA < 50 copies/mL at Week 48 (response rate as defined by the snapshot analysis algorithm). The alternative hypothesis was that the STB group was less than 12% worse than the ATV+RTV+TVD group
    Comparison groups
    Double-Blind STB v Double-Blind ATV+RTV+TVD
    Number of subjects included in analysis
    575
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    6.5
    Confidence interval
         level
    		 95.2%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 12.6
    Notes
    [1] - Difference in percentages of virologic success and its 95.2% confidence interval (CI) were calculated based on baseline HIV-1 RNA and race stratum-adjusted Mantel-Haenszel (MH) proportion.
    Statistical analysis title
    		 HIV-1 RNA < 50 copies/mL - DB STB, DB ATV+RTV+TVD
    Comparison groups
    Double-Blind STB v Double-Blind ATV+RTV+TVD
    Number of subjects included in analysis
    575
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.034 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in proportions
    Point estimate
    6.5
    Confidence interval
         level
    		 95.2%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 12.6
    Notes
    [2] - If non-inferiority of STB versus ATV+RTV+TVD was established, the same 95.2% CI used in evaluating noninferiority was used to evaluate superiority. The baseline HIV-1 RNA and race stratum-stratified, 2-sided CMH test was also used to assess superiority as a secondary assessment.
    [3] - P-value comparing virologic success was from the CMH test stratified by baseline HIV-1 RNA and race strata.

    Secondary: Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase

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    End point title
    		 Change From Baseline in CD4+ Cell Count at Week 48 of the Double-Blind Phase
    End point description
    Participants in the ITT Analysis Set with available data on-treatment were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 Double-Blind STB Double-Blind ATV+RTV+TVD
    Number of subjects analysed
    263
    243
    Units: cells/μL
        arithmetic mean (standard deviation)
    221 ± 165.1
    212 ± 176.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 for the STB group as Determined 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 for the STB group as Determined 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 participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the ITT Analysis Set who received STB through 96 weeks were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 ALL STB
    Number of subjects analysed
    278
    Units: Percentage of participants
        number (confidence interval 95%)
    84.5 (79.7 to 88.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Receiving GEN or ATV+RTV+TVD With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase

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    End point title
    		 Percentage of Participants Receiving GEN or ATV+RTV+TVD With HIV-1 RNA < 50 Copies/mL at Week 48 of the Open-Label Extension Phase
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 of the open-label phase was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the OLE ITT Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Open-Label Extension Week 48
    End point values
    		 Double-Blind ATV+RTV +TVD to Open-Label GEN Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD
    Number of subjects analysed
    159
    53
    Units: Percentage of participants
        number (not applicable)
    94.3
    86.8
    No statistical analyses for this end point

    Secondary: Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase

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    End point title
    		 Change in CD4+ Cell Count at Week 48 of the Open-Label Extension Phase
    End point description
    Participants in the OLE ITT Analysis Set with available data on-treatment were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Open-Label Extension Week 48
    End point values
    		 Double-Blind STB to Open-Label STB Double-Blind ATV+RTV +TVD to Open-Label GEN Double-Blind ATV+RTV+TVD to Open-Label ATV+RTV+TVD
    Number of subjects analysed
    239
    151
    49
    Units: cells/uL
        arithmetic mean (standard deviation)
    265 ± 190.4
    35 ± 137.5
    49 ± 204.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose date up to the last dose date plus 30 days including DB phase and OLE phase (maximum duration: ALL STB = 239.9 weeks; DB ATV+RTV+TVD = 90.6 weeks; DB ATV+ RTV+TVD to OL GEN = 191.3 weeks ; DB ATV+RTV+TVD to OL ATV+RTV+TVD = 102.0 weeks)
    Adverse event reporting additional description
    Adverse events reported included randomized participants who received at least 1 dose of any drug in either DB phase or OLE phase.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Double-Blind: STB
    Reporting group description
    		 Double-Blind Phase: STB 150/150/200/300 mg FDC + ATV placebo + RTV placebo + TVD placebo orally once daily with food for 48 weeks

    Reporting group title
    Double-Blind: ATV +RTV+TVD
    Reporting group description
    		 Double-Blind Phase: ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC + STB placebo orally once daily with food for 48 weeks

    Reporting group title
    DB STB to OL STB
    Reporting group description
    		 Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to receive open-label (OL) STB FDC orally once daily with food for 48 weeks.

    Reporting group title
    DB ATV+RTV+TVD to OL GEN
    Reporting group description
    		 Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label GEN 150/150/200/10 mg FDC orally once daily with food for 48 weeks.

    Reporting group title
    DB ATV+RTV+TVD to OL ATV+RTV+TVD
    Reporting group description
    		 Open-Label Extension Phase: After 48 weeks of blinded treatment participants continued on the blinded treatment for 12 weeks and returned for an unblinding visit at Week 60. Participants who were virologically suppressed at Week 48 during the double-blind phase had the option to be re-randomized and receive open-label ATV 300 mg + RTV 100 mg + TVD (200/300 mg) FDC orally once daily with food for 48 weeks.

    Serious adverse events
    		 Double-Blind: STB Double-Blind: ATV +RTV+TVD DB STB to OL STB DB ATV+RTV+TVD to OL GEN DB ATV+RTV+TVD to OL ATV+RTV+TVD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 289 (8.65%)
    29 / 286 (10.14%)
    13 / 246 (5.28%)
    12 / 159 (7.55%)
    4 / 53 (7.55%)
         number of deaths (all causes)
    0
    0
    2
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix carcinoma
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    1 / 159 (0.63%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    2 / 289 (0.69%)
    2 / 286 (0.70%)
    1 / 246 (0.41%)
    3 / 159 (1.89%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ectopic pregnancy
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gestational hypertension
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Imminent abortion
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ruptured ectopic pregnancy
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine hypertonus
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    1 / 159 (0.63%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    1 / 159 (0.63%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 289 (0.35%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    1 / 159 (0.63%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine haemorrhage
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 289 (0.69%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neonatal respiratory distress
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    2 / 289 (0.69%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Confusional state
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    1 / 159 (0.63%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Conversion disorder
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    1 / 159 (0.63%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression suicidal
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomegaly
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    1 / 159 (0.63%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    1 / 159 (0.63%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Chalazion
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    1 / 159 (0.63%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    1 / 159 (0.63%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic hepatitis
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Stevens-Johnson syndrome
         subjects affected / exposed
    1 / 289 (0.35%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erythema multiforme
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 289 (0.00%)
    2 / 286 (0.70%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 289 (0.00%)
    2 / 286 (0.70%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    2 / 289 (0.69%)
    1 / 286 (0.35%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 289 (0.35%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone tuberculosis
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast abscess
         subjects affected / exposed
    0 / 289 (0.00%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Catheter site infection
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic inflammatory disease
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syphilis
         subjects affected / exposed
    0 / 289 (0.00%)
    1 / 286 (0.35%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 289 (0.35%)
    0 / 286 (0.00%)
    1 / 246 (0.41%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Double-Blind: STB Double-Blind: ATV +RTV+TVD DB STB to OL STB DB ATV+RTV+TVD to OL GEN DB ATV+RTV+TVD to OL ATV+RTV+TVD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    176 / 289 (60.90%)
    194 / 286 (67.83%)
    118 / 246 (47.97%)
    68 / 159 (42.77%)
    20 / 53 (37.74%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    49 / 289 (16.96%)
    44 / 286 (15.38%)
    27 / 246 (10.98%)
    20 / 159 (12.58%)
    5 / 53 (9.43%)
         occurrences all number
    56
    58
    36
    28
    5
    Neuropathy peripheral
         subjects affected / exposed
    21 / 289 (7.27%)
    20 / 286 (6.99%)
    12 / 246 (4.88%)
    10 / 159 (6.29%)
    7 / 53 (13.21%)
         occurrences all number
    27
    24
    12
    14
    7
    Dizziness
         subjects affected / exposed
    17 / 289 (5.88%)
    10 / 286 (3.50%)
    7 / 246 (2.85%)
    0 / 159 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    18
    10
    9
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    11 / 289 (3.81%)
    14 / 286 (4.90%)
    18 / 246 (7.32%)
    4 / 159 (2.52%)
    0 / 53 (0.00%)
         occurrences all number
    12
    15
    20
    5
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 289 (2.77%)
    15 / 286 (5.24%)
    2 / 246 (0.81%)
    3 / 159 (1.89%)
    2 / 53 (3.77%)
         occurrences all number
    9
    16
    2
    3
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    43 / 289 (14.88%)
    41 / 286 (14.34%)
    6 / 246 (2.44%)
    7 / 159 (4.40%)
    2 / 53 (3.77%)
         occurrences all number
    51
    46
    6
    7
    2
    Vomiting
         subjects affected / exposed
    28 / 289 (9.69%)
    17 / 286 (5.94%)
    3 / 246 (1.22%)
    4 / 159 (2.52%)
    0 / 53 (0.00%)
         occurrences all number
    33
    18
    4
    4
    0
    Diarrhoea
         subjects affected / exposed
    15 / 289 (5.19%)
    19 / 286 (6.64%)
    6 / 246 (2.44%)
    5 / 159 (3.14%)
    1 / 53 (1.89%)
         occurrences all number
    20
    20
    7
    5
    1
    Dyspepsia
         subjects affected / exposed
    13 / 289 (4.50%)
    15 / 286 (5.24%)
    4 / 246 (1.63%)
    3 / 159 (1.89%)
    0 / 53 (0.00%)
         occurrences all number
    15
    15
    4
    3
    0
    Abdominal pain
         subjects affected / exposed
    17 / 289 (5.88%)
    9 / 286 (3.15%)
    1 / 246 (0.41%)
    3 / 159 (1.89%)
    2 / 53 (3.77%)
         occurrences all number
    20
    9
    1
    3
    2
    Hepatobiliary disorders
    Ocular icterus
         subjects affected / exposed
    1 / 289 (0.35%)
    34 / 286 (11.89%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    36
    0
    0
    0
    Jaundice
         subjects affected / exposed
    1 / 289 (0.35%)
    30 / 286 (10.49%)
    0 / 246 (0.00%)
    0 / 159 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    1
    34
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    20 / 289 (6.92%)
    18 / 286 (6.29%)
    12 / 246 (4.88%)
    9 / 159 (5.66%)
    2 / 53 (3.77%)
         occurrences all number
    25
    22
    13
    10
    2
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    20 / 289 (6.92%)
    17 / 286 (5.94%)
    13 / 246 (5.28%)
    14 / 159 (8.81%)
    1 / 53 (1.89%)
         occurrences all number
    24
    19
    14
    15
    1
    Arthralgia
         subjects affected / exposed
    10 / 289 (3.46%)
    21 / 286 (7.34%)
    9 / 246 (3.66%)
    5 / 159 (3.14%)
    1 / 53 (1.89%)
         occurrences all number
    13
    24
    10
    6
    1
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    50 / 289 (17.30%)
    45 / 286 (15.73%)
    36 / 246 (14.63%)
    23 / 159 (14.47%)
    10 / 53 (18.87%)
         occurrences all number
    81
    64
    60
    30
    12
    Malaria
         subjects affected / exposed
    34 / 289 (11.76%)
    25 / 286 (8.74%)
    14 / 246 (5.69%)
    8 / 159 (5.03%)
    1 / 53 (1.89%)
         occurrences all number
    45
    31
    18
    9
    1
    Urinary tract infection
         subjects affected / exposed
    22 / 289 (7.61%)
    23 / 286 (8.04%)
    15 / 246 (6.10%)
    9 / 159 (5.66%)
    0 / 53 (0.00%)
         occurrences all number
    25
    23
    18
    9
    0
    Influenza
         subjects affected / exposed
    20 / 289 (6.92%)
    20 / 286 (6.99%)
    14 / 246 (5.69%)
    12 / 159 (7.55%)
    1 / 53 (1.89%)
         occurrences all number
    24
    25
    15
    19
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    21 / 289 (7.27%)
    20 / 286 (6.99%)
    15 / 246 (6.10%)
    6 / 159 (3.77%)
    4 / 53 (7.55%)
         occurrences all number
    27
    25
    17
    8
    6
    Nasopharyngitis
         subjects affected / exposed
    15 / 289 (5.19%)
    14 / 286 (4.90%)
    8 / 246 (3.25%)
    6 / 159 (3.77%)
    0 / 53 (0.00%)
         occurrences all number
    22
    21
    15
    7
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    15 / 289 (5.19%)
    14 / 286 (4.90%)
    3 / 246 (1.22%)
    0 / 159 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    16
    15
    3
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Aug 2012
    • Updated following Food and Drug Administration (FDA) approval of Stribild • Changed HIV-1 RNA inclusion criteria (from ≥ 1,000 copies/mL to ≥ 500 copies/mL) • Updated and clarified post-Week 48 visits • Added study sites in Mexico and Russia • Updated study questionnaires • Removed dosing diary requirement for regular study visits (to be administered for intensive pharmacokinetic (PK) substudy only) • Added hair specimen collection PK substudy • Added cervicovaginal fluid (CVF) PK substudy • Updated and clarified intensive PK substudy to intensive oral contraceptive (OC) PK substudy • Added Cystatin C and Urine Chemistry at all visits Baseline through unblinding • Updated demographic and medical history information to be collected at screening visit • Clarified adverse event (AE) and serious adverse event (SAE) reporting through the electronic case report form (eCRF) system • Clarified adverse event (AE) and serious adverse event (SAE) reporting through the electronic case report form (eCRF) system • Added another secondary efficacy endpoint: The proportion of subjects who have virologic failure, using the US FDA-defined snapshot algorithm, at Week 48 • Clarified risk-benefit assessment measures provided to Independent Data Monitoring Committee (IDMC) • General formatting/spelling corrections
    21 Jan 2014
    • Added a 48 week OLE ̶ Subjects initially randomized to the STB group (Treatment Group 1) had the option to continue open-label STB at Week 60 (Unblinding Visit/OLE Week 0) for an additional 48 weeks on study as part of an OLE. ̶ Subjects initially randomized to the ATV/r+TVD group (Treatment Group 2) had the option to be rerandomized to continue ATV/r+TVD or switch to GEN in a 1:3 randomization at Week 60 for an additional 48 weeks on study as part of an OLE. • Additional dual-energy x-ray absorptiometry (DXA) data were obtained in the STB group in the OLE at Week 48. • DXA data in subjects from Treatment Group 2 who elected to continue in the OLE were collected at open-label Weeks 0, 24 and 48. • Added OC PK substudy to assess drug-drug interaction (DDI) between oral hormonal contraceptives and components of study drugs during the OLE in the STB group. This intensive PK study was completed after 7 days of administration of an OC regimen in women receiving open-label STB. • Updated number of sites and list of countries (100 sites/countries included US, Mexico,Puerto Rico, Europe, Russia, Uganda, Dominican Republic, and Thailand) • Added secondary objectives to evaluate the safety, efficacy, and tolerability of STB STR,ATV/r+TVD and GEN STR in the OLE Updated statistical methods to assess the secondary endpoints • Updated background information with new data on STB and provided background on GEN • Updated concomitant medication guidelines to be consistent with current labeling for STB and GEN • Added hepatitis B virus surface antigen test and anti-hepatitis C antibody test at baseline and Week 60 (Unblinding Visit/OLE Week 0) • Updated virologic management guidelines to include retesting window for any virologic rebounds over > 50 copies/mL • Updated safety reporting contact information

    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/27562742
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