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    Clinical Trial Results:
    A Phase 3, Randomized, Active-controlled, Double-blind study to Evaluate Efficacy and Safety of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) Once Daily Fixed Dose Combination Regimen Versus a Regimen Consisting of Darunavir/Cobicistat Fixed Dose Combination Coadministered With Emtricitabine/Tenofovir Disoproxil Fumarate Fixed Dose Combination in Antiretroviral Treatment-naive Human Immunodeficiency Virus type 1 Infected Subjects

    Summary
    EudraCT number
    		 2015-000754-38
    Trial protocol
    		 BE   ES   GB   PL   IT  
    Global end of trial date
    30 Sep 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2021
    First version publication date
    16 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CR107277
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02431247
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Sciences Ireland UC
    Sponsor organisation address
    Barnahely, Cork, Ireland, P43 FA46
    Public contact
    Clinical Registry Group, Janssen Sciences Ireland UC, clinicaltrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Sciences Ireland UC, clinicaltrialsEU@its.jnj.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
    30 Sep 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Sep 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to demonstrate non-inferiority in efficacy of a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC) tablet versus Darunavir/Cobicistat (DRV/COBI) FDC coadministered with Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in human immunodeficiency virus-1 (HIV-1) infected, antiretroviral (ARV) treatment naive adult subjects, as determined by the proportion of virologic responders defined as having HIV 1 Ribonucleic Acid (RNA) less than (<) 50 copies per milliliter (copies per mL) at Week 48 (Food and Drug Administration [FDA]-defined snapshot analysis), with a maximum allowable difference of 10 percent (%).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices (GCP) and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jul 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 25
    Country: Number of subjects enrolled
    Canada: 32
    Country: Number of subjects enrolled
    Germany: 88
    Country: Number of subjects enrolled
    Spain: 138
    Country: Number of subjects enrolled
    France: 51
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    Italy: 80
    Country: Number of subjects enrolled
    Poland: 78
    Country: Number of subjects enrolled
    Russian Federation: 86
    Country: Number of subjects enrolled
    United States: 133
    Worldwide total number of subjects
    725
    EEA total number of subjects
    460
    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)
    724
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 725 subjects (362 to D/C/F/TAF group and 363 in control group). 296 subjects in D/C/F/TAF group and 289 subjects in control group completed the study and 66 subject in D/C/F/TAF group and 74 subjects in control group discontinued the study.

    Period 1
    Period 1 title
    BL to EOE-Test and BL to Switch- Control
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])
    Arm description
    		 Subjects received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). After Week 48 analysis unblinding visit, all subjects received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, subjects were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Darunavir 800 mg/Cobicistat 150 mg/Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg (D/C/F/TAF) FDC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single oral tablet of D/C/F/TAF 800/150/200/10 mg FDC once daily.

    Investigational medicinal product name
    FTC/TDF FDC-matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received a single oral placebo tablet matching to FTC/TDF FDC once daily.

    Investigational medicinal product name
    DRV/COBI FDC-matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received a single oral placebo tablet matching to DRV/COBI FDC once daily.

    Arm title
    		 DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Arm description
    		 Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    D/C/F/TAF FDC-matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received a single oral placebo tablet matching to D/C/F/TAF FDC once daily.

    Investigational medicinal product name
    FTC/TDF FDC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received a single oral tablet of FTC/TDF FDC once daily.

    Investigational medicinal product name
    DRV/COBI FDC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject received a single oral tablet of DRV/COBI FDC once daily.

    Number of subjects in period 1
    		D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Started
    362
    363
    Completed
    296
    322
    Not completed
    66
    41
         Adverse event, serious fatal
    -
    1
         Physician decision
    9
    4
         Consent withdrawn by subject
    14
    9
         Adverse event, non-fatal
    12
    16
         Pregnancy
    1
    1
         Non-compliance with study drug
    2
    -
         Unspecified
    11
    2
         Lost to follow-up
    17
    8
    Period 2
    Period 2 title
    Switch to D/C/F/TAF (until EOE)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Switch to D/C/F/TAF
    Arm description
    		 After Week 48 analysis unblinding visit, subjects earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, subjects were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.
    Arm type
    		 Experimental

    Investigational medicinal product name
    D/C/F/TAF FDC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single oral tablet of D/C/F/TAF FDC once daily.

    Number of subjects in period 2 [1]
    		Switch to D/C/F/TAF
    Started
    322
    Completed
    289
    Not completed
    33
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    10
         Physician decision
    1
         Adverse event, non-fatal
    5
         Unspecified
    4
         Lost to follow-up
    12
    Notes
    [1] - 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: Out of 363 subjects in the DRV/COBI+ FTC/TDF (Control) group, 322 subjects switched to D/C/F/TAF treatment after Week 48 or unblinding.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])
    Reporting group description
    		 Subjects received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). After Week 48 analysis unblinding visit, all subjects received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, subjects were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available.

    Reporting group title
    DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Reporting group description
    		 Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48).

    Reporting group values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) Total
    Number of subjects
    		 362 363 725
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 362 362 724
        From 65 to 84 years
    		 0 1 1
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        median (full range (min-max))
    		 34 (19 to 61) 34 (18 to 71) -
    Title for Gender
    Units: subjects
        Female
    		 44 41 85
        Male
    		 318 322 640

    End points

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    End points reporting groups
    Reporting group title
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE])
    Reporting group description
    		 Subjects received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). After Week 48 analysis unblinding visit, all subjects received D/C/F/TAF treatment up to Week 96 during the open-label, single-group treatment phase. After Week 96, subjects were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available.

    Reporting group title
    DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Reporting group description
    		 Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48).
    Reporting group title
    Switch to D/C/F/TAF
    Reporting group description
    		 After Week 48 analysis unblinding visit, subjects earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, subjects were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.

    Subject analysis set title
    Darunavir 800 mg (D/C/F/TAF [Test])
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received DRV 800 mg along with COBI 150 mg, FTC 200 mg, TAF 10 mg as a (D/C/F/TAF) FDC oral tablet once daily along with DRV/COBI FDC matching placebo and FTC/TDF FDC-matching placebo tablets once daily up to Week 48.

    Subject analysis set title
    Tenofovir Alafenamide 10 mg (D/C/F/TAF [Test])
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received TAF 10 mg along with DRV 800 mg, COBI 150 mg, FTC 200 mg as a (D/C/F/TAF) FDC oral tablet once daily along with DRV/COBI FDC-matching placebo and FTC/TDF FDC-matching placebo tablets once daily up to Week 48.

    Primary: Percentage of Subjects With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) less than (<) 50 Copies per Milliliter (Copies per mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach

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    End point title
    		 Percentage of Subjects With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) less than (<) 50 Copies per Milliliter (Copies per mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach
    End point description
    Percentage of subjects with a HIV-1 RNA < 50 copies per mL were assessed using FDA snapshot approach which defines a subject's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified subjects into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 48), 3) no viral load data in the Week 48 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. The intent-to-treat (ITT) analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here N (number of subjects analyzed) refers to 363 for test group and 363 for control group.
    End point type
    Primary
    End point timeframe
    At Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    362
    363
    Units: percentage of subjects
        number (confidence interval 95%)
    91.4 (88.1 to 94.1)
    88.4 (84.7 to 91.5)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    725
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.001 [1]
    Method
    		 Mantel-Haenszel
    Parameter type
    		 Difference in percentage
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.6
         upper limit
    		 7.1
    Notes
    [1] - One-sided p-value for non-inferiority of Test versus Control arm. The non-inferiority margin is 10%.

    Secondary: Percentage of Subjects With HIV-1 RNA <20 and 200 Copies per mL at Week 48 and 96 Defined by FDA Snapshot Approach

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    End point title
    		 Percentage of Subjects With HIV-1 RNA <20 and 200 Copies per mL at Week 48 and 96 Defined by FDA Snapshot Approach
    End point description
    Percentage of subjects with HIV-1 RNA < 20/200 copies per mL using FDA snapshot approach were reported. The snapshot approach classified subjects into 3 outcome categories: 1) virologic success (HIV RNA < 20/50/200 copies per mL at Week 48 and 96), 2) virologic failure (HIV RNA >= 20/50/200 copies per mL at Week 48 and 96), 3) no viral load data in the Week 48 and 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Here, 99999 refers that subjects received treatment from baseline till Week 48/Switch in control arm and from switch till Week 96 in Switch to D/C/F/TAF arm. Therefore, Week 96 and Week 48 data was not collected for both arms at respective timepoints.
    End point type
    Secondary
    End point timeframe
    At Weeks 48 and 96
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    362
    291
    363
    Units: percentage of subjects
    number (confidence interval 95%)
        At 48 week: <20 Copies per mL
    82.6 (78.3 to 86.4)
    99999 (99999 to 99999)
    79.3 (74.8 to 83.4)
        At 48 week: <200 Copies per mL
    92.8 (89.7 to 95.3)
    99999 (99999 to 99999)
    90.6 (87.2 to 93.4)
        At 96 week: <20 Copies per mL
    76.2 (71.5 to 80.5)
    83.5 (78.7 to 87.6)
    99999 (99999 to 99999)
        At 96 week: <200 Copies per mL
    86.2 (82.2 to 89.6)
    96.9 (94.2 to 98.6)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HIV-1 RNA < 20, 50, and 200 Copies per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm

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    End point title
    		 Percentage of Subjects with HIV-1 RNA < 20, 50, and 200 Copies per mL at Week 48 and 96 Defined by the Time to Loss of Virologic Response (TLOVR) Algorithm
    End point description
    Percentage of subjects with HIV-1 RNA l<20, 50, and 200 copies per mL at Weeks 48 and 96 based on TLOVR algorithm were assessed. TLOVR requires sustained HIV-1 RNA < 50 copies per mL; confirmed HIV-1 RNA >= 50 copies per mL is considered as non-response (rebound); subject is considered non-responder after permanent discontinuation. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint. Here, 99999 refers that subjects received treatment from baseline till Week 48/Switch in control arm and from switch till Week 96 in Switch to D/C/F/TAF arm. Therefore, Week 96 and Week 48 data was not collected for both arms at respective timepoints.
    End point type
    Secondary
    End point timeframe
    At Week 48 and 96
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    362
    291
    363
    Units: percentage of subjects
    number (confidence interval 95%)
        At Week 48: < 20 Copies per mL
    82.6 (78.3 to 86.4)
    99999 (99999 to 99999)
    79.9 (75.4 to 83.9)
        At Week 48: <50 Copies per mL
    91.2 (87.8 to 93.9)
    99999 (99999 to 99999)
    88.7 (85.0 to 91.8)
        At Week 48: <200 Copies per mL
    93.1 (90.0 to 95.5)
    99999 (99999 to 99999)
    91.7 (88.4 to 94.4)
        At Week 96: <20 Copies per mL
    73.2 (68.3 to 77.7)
    78.4 (73.2 to 82.9)
    99999 (99999 to 99999)
        At Week 96: <50 Copies per mL
    85.1 (81.0 to 88.6)
    93.8 (90.4 to 96.3)
    99999 (99999 to 99999)
        At Week 96: <200 Copies per mL
    86.7 (82.8 to 90.1)
    96.9 (94.2 to 98.6)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Change From Baseline in log10 HIV-1 RNA Levels at Week 48

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    End point title
    		 Change From Baseline in log10 HIV-1 RNA Levels at Week 48
    End point description
    Change from baseline in log10 HIV-1 RNA levels were reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Based on not completed (NC) equal to (=) failure (F) analysis with values after discontinuation imputed with the baseline value. Other (intermittent) missing values are imputed using last observation carried forward (LOCF).
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    362
    363
    Units: log10 HIV-1 RNA copies per mL
        least squares mean (standard error)
    -2.95 ( 0.044 )
    -2.91 ( 0.044 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    725
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.437
    Method
    		 ANCOVA
    Parameter type
    		 Least square mean difference
    Point estimate
    -0.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.171
         upper limit
    		 0.074
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.063

    Secondary: Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48

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    End point title
    		 Change From Baseline in Cluster of Differentiation-4 (CD4+) Cell Count at Week 48
    End point description
    The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Week 48 were assessed. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Based on NC = F analysis with values after discontinuation imputed with the baseline value. Other (intermittent) missing values are imputed using LOCF.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    362
    363
    Units: Cells per millimeter cube (cells/mm^3)
        least squares mean (standard error)
    190.49 ( 10.472 )
    172.01 ( 10.458 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    725
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.213
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    18.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.595
         upper limit
    		 47.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    14.808

    Secondary: Change From Baseline in Serum Creatinine at Week 48

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    End point title
    		 Change From Baseline in Serum Creatinine at Week 48
    End point description
    Change from baseline in serum creatinine at Week 48 was reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    340
    330
    Units: milligram per deciliter (mg/dL)
        least squares mean (standard error)
    0.05 ( 0.006 )
    0.09 ( 0.006 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    670
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.05
         upper limit
    		 -0.02
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.008

    Secondary: Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula at Week 48

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    End point title
    		 Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine (eGFRcr) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula at Week 48
    End point description
    Change from baseline in eGFRcr was calculated using the CKD-EPI equation as per which Stage 1 (normal or high GFR [>=90 mL/min]); Stage 2 (Mild CKD [60 to 90 mL/min]); Stage 3 (Moderate CKD [30 to 59mL/min]); Stage 4 (Severe CKD [15 to 29 mL/min]); Stage 5 (End Stage CKD [<15 mL/min]). The eGFRcr was assessed by calculating serum creatinine (Scr) using the equation: eGFRcr milliliter per minute per 1.72 meter square (mL/min/1.73m^2) = 144 x (Scr/0.7)^-0.329 x 0.993^age (Scr =< 0.7 mg/dL) and eGFRcr mL/min/1.73m^2 = 144 x (Scr/0.7)^-1.209 x 0.993^age (Scr >0.7 mg/dL) for female subjects and eGFRcr mL/min/1.73m^2 = 141 x (Scr/0.9)^-0.411 x 0.993^age (Scr =<0.9 mg/dL) and eGFRcr mL/min/1.73m^2 = 141 x (Scr/0.9)^-1.209 x 0.993^age (Scr >0.9 mg/dL) for male subjects. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    340
    330
    Units: mL/min/1.73 m^2
        least squares mean (standard error)
    -6.04 ( 0.551 )
    -9.16 ( 0.559 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    670
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    3.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.57
         upper limit
    		 4.66
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.786

    Secondary: Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine by (Cockcroft-Gault Formula) at Week 48

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    End point title
    		 Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Creatinine by (Cockcroft-Gault Formula) at Week 48
    End point description
    Change from baseline in eGFRcr by (cockcroft-gault formula) was reported. The eGFRcr was assessed by calculated creatinine clearance (CrCl) using the Cockcroft-Gault formula, and was assessed using CrCl [mL/min] = (140 – A) * W / (72 * C) * R. Where A is age at sample date [years], W is body weight at specific visit (kilogram [kg]), C is the serum concentration of creatinine [mg/dL], R=1 if the subject is male and = 0.85 if female. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    340
    330
    Units: milliliter per minute (mL/min)
        least squares mean (standard error)
    -5.16 ( 0.790 )
    -11.20 ( 0.802 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    670
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    6.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.83
         upper limit
    		 8.25
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.126

    Secondary: Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula at Week 48

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    End point title
    		 Change From Baseline in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula at Week 48
    End point description
    Change from baseline in eGFRcyst was calculated using the CKD-EPI equation as per which Stage 1 (normal or high GFR) >= 90 indicates normal kidney function; Stage 2 (Mild CKD): 60 to 89 mL/min indicates mildly reduced kidney function; Stage 3 (Moderate CKD): 30 to 59 mL/min indicates moderately reduced kidney function; Stage 4 (Severe CKD): 15 to 29 mL/min indicates severely reduced kidney function; Stage 5 (End Stage of CKD): <15 mL/min indicate very severe or end stage kidney failure. The eGFRcyst was assessed by calculated serum cystatin C (Scyst) using the equation: eGFRcyst mL/min/1.73m^2 = 133 x (Scyst/0,8)^-0.499 x 0.996^age [x 0.932 if female] (Scyst =<0.8 mg/L) and eGFRcr mL/min/1.73m^2 = 133 x (Scyst/0,8)^-1.328 x 0.996^age [x 0.932 if male] (Scyst >0.8 mg/L). The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    337
    329
    Units: mL/min/1.73 m^2
        least squares mean (standard error)
    5.32 ( 0.525 )
    2.92 ( 0.532 )
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    666
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    2.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 3.87
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.747

    Secondary: Percentage of Subjects With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations due to Adverse Events Through Week 48

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    End point title
    		 Percentage of Subjects With Grade 3 and 4 Adverse Events (AEs), Serious Adverse Events (SAEs), and Premature Discontinuations due to Adverse Events Through Week 48
    End point description
    AE is any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize subject and/or may require medical or surgical intervention to prevent one of the outcomes listed above. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    362
    363
    Units: percentage of subjects
    number (not applicable)
        Grade 3 AEs
    4.7
    4.4
        Grade 4 AEs
    0.6
    1.7
        SAEs
    4.7
    5.8
        Premature discontinuations due to AEs
    1.9
    4.4
    No statistical analyses for this end point

    Secondary: Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48

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    End point title
    		 Change From Baseline in Urine Protein to Creatinine Ratio (UPCR) at Week 48
    End point description
    Change from baseline in UPCR at Week 48 was reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    336
    325
    Units: milligram per gram (mg/g)
        median (full range (min-max))
    -15.72 (-748.1 to 254.2)
    -10.53 (-903.0 to 1546.1)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    661
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.033
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48

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    End point title
    		 Change From Baseline in Urine Albumin to Creatinine Ratio (UACR) at Week 48
    End point description
    Change from baseline in UACR at Week 48 was reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    338
    327
    Units: mg/g
        median (full range (min-max))
    -0.58 (-226.5 to 143.8)
    -0.15 (-640.4 to 969.6)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    665
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.033
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48

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    End point title
    		 Change From Baseline in Urine Retinol Binding Protein To Creatinine Ratio (URBPCR) at Week 48
    End point description
    Change from baseline in URBPCR at Week 48 was reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    334
    324
    Units: microgram per gram (mcg/g)
        median (full range (min-max))
    7.00 (-1555.7 to 5183.8)
    35.02 (-700.7 to 30350.2)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    658
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48

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    End point title
    		 Change From Baseline in Urine Beta-2 Microglobulin to Creatinine Ratio (UB2MGCR) at Week 48
    End point description
    Change from baseline in UB2MGCR at Week 48 was reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    331
    320
    Units: mcg/g
        median (full range (min-max))
    -30.42 (-11818.6 to 3452.0)
    18.36 (-2440.5 to 90832.0)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    651
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48

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    End point title
    		 Percent Change From Baseline in Urine Fractional Excretion of Phosphate (FEPO4) at Week 48
    End point description
    Percent change from baseline in FEPO4 at Week 48 was reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    339
    329
    Units: Percent change in urine FEP04
        median (full range (min-max))
    16.00 (-87.3 to 1756.6)
    22.55 (-90.1 to 1720.7)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    668
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.147
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours Post-dose (AUC0-24h) of Darunavir
    End point description
    AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours post-dose. Pharmacokinetic(PK) analysis set: all subjects who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of DRV was analyzed only for test arm as per planned analyses. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    0 to 24 hours post dose
    End point values
    		 Darunavir 800 mg (D/C/F/TAF [Test])
    Number of subjects analysed
    355
    Units: hour*nanogram per milliliter (h*ng/mL)
        arithmetic mean (standard deviation)
    87909.3282 ( 20232.09905 )
    No statistical analyses for this end point

    Secondary: Predose (Trough) Plasma Concentration (C0h) of Darunavir

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    End point title
    		 Predose (Trough) Plasma Concentration (C0h) of Darunavir
    End point description
    C0h is defined as the predose (trough) plasma concentration or concentration just prior to study drug administration. PK analysis set: all subjects who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of DRV was analyzed only for test arm as per planned analyses. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)
    End point values
    		 Darunavir 800 mg (D/C/F/TAF [Test])
    Number of subjects analysed
    355
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    1898.9100 ( 758.83837 )
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide

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    End point title
    		 Area Under the Plasma Concentration Time Curve Across the Dosing Interval (AUCtau) of Tenofovir Alafenamide
    End point description
    The AUCtau is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption. PK analysis set: all subjects who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of TAF was analyzed only for test arm as per planned analyses. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    30 minutes to 4 hours postdose at Weeks 2, 4, 12, 24 and 48 and at 2 timepoints with at least 2.5 hours in between sampling at Week 8 and 36 (first sample between 1 and 4 hours postdose)
    End point values
    		 Tenofovir Alafenamide 10 mg (D/C/F/TAF [Test])
    Number of subjects analysed
    355
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    132.3117 ( 40.87742 )
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD)

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    End point title
    		 Percent Change From Baseline in Hip and Spine Bone Mineral Density (BMD)
    End point description
    The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by dual energy x-ray absorptiometry (DEXA) scan. Positive values are "best values" and negative values are "worst values" of change. Percent change from baseline in hip and spine BMD was assessed. Bone investigation substudy (BIS) analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, n (number analyzed) signifies subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24 and 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    113
    99
    Units: Percent change
    least squares mean (standard error)
        Hip region BMD (Week 24) n= 97, 82
    0.29 ( 0.248 )
    -1.66 ( 0.269 )
        Spine region BMD (Week 24) n=96, 82
    -1.34 ( 0.285 )
    -3.43 ( 0.309 )
        Hip region BMD (Week 48) n=96, 85
    0.17 ( 0.322 )
    -2.69 ( 0.342 )
        Spine region BMD (Week 48) n=96, 85
    -0.68 ( 0.402 )
    -2.38 ( 0.428 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Hip region BMD (Week 24)
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    1.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.227
         upper limit
    		 2.678
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.368
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Hip region BMD (Week 48)
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    2.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.934
         upper limit
    		 3.791
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.47
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Spine region BMD (Week 24)
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    2.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.259
         upper limit
    		 2.919
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.421
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Spine region BMD (Week 48)
    Comparison groups
    D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) v DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects included in analysis
    212
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 ANCOVA
    Parameter type
    		 LS mean difference
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.539
         upper limit
    		 2.858
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.588

    Secondary: Plasma Concentrations 2 hours After Dosing (C0-2h) of Tenofovir Alafenamide

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    End point title
    		 Plasma Concentrations 2 hours After Dosing (C0-2h) of Tenofovir Alafenamide
    End point description
    C0-2h is defined as the plasma concentrations 2 hours after dosing. PK analysis set: all subjects who were randomized, received at least 1 dose of study drug and plasma concentration data for analytes of interest were available. PK data of TAF was analyzed only for test arm as per planned analyses. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    0 to 2 hours post dose
    End point values
    		 Tenofovir Alafenamide 10 mg (D/C/F/TAF [Test])
    Number of subjects analysed
    355
    Units: ng/mL
        arithmetic mean (standard deviation)
    11.9785 ( 11.86104 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in BMD T-score of Hip and Spine

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    End point title
    		 Change From Baseline in BMD T-score of Hip and Spine
    End point description
    BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, n (number analyzed) signifies subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24 and 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    113
    99
    Units: BMD T-score
    arithmetic mean (standard error)
        Hip region BMD T-score (Week 24) n= 97, 82
    0.019 ( 0.0180 )
    -0.109 ( 0.0157 )
        Spine region BMD T-score (Week 24) n= 96, 82
    -0.121 ( 0.0259 )
    -0.322 ( 0.0307 )
        Hip region BMD T-score (Week 48) n= 96, 85
    0.015 ( 0.0213 )
    -0.177 ( 0.0225 )
        Spine region BMD T-score (Week 48) n= 96, 85
    -0.061 ( 0.0390 )
    -0.225 ( 0.0386 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Alkaline Phosphatase (ALP) Levels at Week 24 and 48

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    End point title
    		 Change From Baseline in Alkaline Phosphatase (ALP) Levels at Week 24 and 48
    End point description
    Change from baseline in ALP at Weeks 24 and 48 were reported. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, n (number analyzed) signifies subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24 and 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    113
    99
    Units: Units per liter (U/L)
    arithmetic mean (standard error)
        Week 24: n=103, 88
    -3.2 ( 1.17 )
    12.0 ( 1.74 )
        Week 48: n=97, 85
    -1.1 ( 1.29 )
    15.1 ( 2.00 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Week 24 and 48

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    End point title
    		 Change From Baseline in Levels of Serum Procollagen 1 N-Terminal Propeptide (P1NP) at Week 24 and 48
    End point description
    Change from baseline in serum P1NP at Weeks 24 and 48 were reported. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, n (number analyzed) signifies subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24 and 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    113
    99
    Units: microgram per liter (mcg/L)
    arithmetic mean (standard error)
        Week 24: n= 101, 95
    1.892 ( 1.3754 )
    24.679 ( 2.0956 )
        Week 48: n= 96, 84
    0.065 ( 1.6428 )
    24.251 ( 2.6337 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Week 24 and 48

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    End point title
    		 Change From Baseline in Levels of Serum Collagen Type 1 Beta Carboxy Telopeptide (CTX) at Week 24 and 48
    End point description
    Change from baseline in serum CTX at Week 24 and 48 were reported. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, n (number analyzed) signifies subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24 and 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    113
    99
    Units: mcg/L
    arithmetic mean (standard error)
        Week 24: n= 103, 83
    0.047 ( 0.0165 )
    0.283 ( 0.0251 )
        Week 48: n= 97, 81
    0.046 ( 0.0174 )
    0.226 ( 0.0234 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Levels of Parathyroid Hormone (PTH) at Week 24 and 48

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    End point title
    		 Change From Baseline in Levels of Parathyroid Hormone (PTH) at Week 24 and 48
    End point description
    Change from baseline in PTH at Week 24 and 48 were reported. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, n (number analyzed) signifies subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24 and 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    113
    99
    Units: Picomol per liter (pmol/L)
    arithmetic mean (standard error)
        Week 24: n= 101, 83
    0.113 ( 0.2171 )
    0.777 ( 0.2401 )
        Week 48: n= 95, 83
    -0.004 ( 0.2232 )
    0.633 ( 0.2155 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48

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    End point title
    		 Change From Baseline in Levels of 25-Hydroxyvitamin D (25-OH Vitamin D), at Week 24 and 48
    End point description
    Change from baseline in 25-OH Vitamin D at Week 24 and 48 was reported. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, n (number analyzed) signifies subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24 and 48
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    113
    99
    Units: nanomol per liter (nmol/L)
    arithmetic mean (standard error)
        Week 24 n= 101, 84
    12.7 ( 2.76 )
    22.1 ( 3.76 )
        Week 48 n= 97, 82
    16.9 ( 2.84 )
    28.3 ( 3.15 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HIV-1 RNA <50 Copies per mL at Week 96 Defined by FDA Snapshot Approach

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    End point title
    		 Percentage of Subjects With HIV-1 RNA <50 Copies per mL at Week 96 Defined by FDA Snapshot Approach [2]
    End point description
    Percentage of subjects with a HIV-1 RNA <50 copies per mL were assessed using FDA snapshot approach which defines a subject's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. The snapshot approach classified subjects into 3 outcome categories: 1) virologic success (HIV RNA <20/50/200 copies per mL at Week 96), 2) virologic failure (HIV RNA greater than or equal to [>=] 20/50/200 copies per mL at Week 96), 3) no viral load data in the Week 96 visit window (discontinued due to adverse event/death/other reason). The missing HIV-1 RNA is considered as non-response. The intent-to-treat (ITT) analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    At Week 96
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    362
    291
    Units: percentage of subjects
        number (confidence interval 95%)
    85.1 (81.0 to 88.6)
    94.2 (90.8 to 96.6)
    No statistical analyses for this end point

    Secondary: Change From Reference in log10 HIV-1 RNA Levels

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    End point title
    		 Change From Reference in log10 HIV-1 RNA Levels [3]
    End point description
    Change from reference in log10 HIV-1 RNA levels were reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Based on not completed (NC) equal to (=) failure (F) analysis with values after discontinuation imputed with the baseline value. Other (intermittent) missing values are imputed using last observation carried forward (LOCF). Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    362
    289
    Units: log10 HIV-1 RNA copies per mL
        least squares mean (standard error)
    -2.72 ( 0.0614 )
    -0.0027 ( 0.0131 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with >95% Treatment Adherence Assessed by Drug Accountability

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    End point title
    		 Percentage of Subjects with >95% Treatment Adherence Assessed by Drug Accountability
    End point description
    Treatment adherence assessed by drug accountability (based on pill count) from start of treatment/switch to last study drug intake by determination of the cumulative treatment adherence in subjects who returned all dispensed bottles prior to or at the last visit in the study. Adherent subjects were defined as having an adherence >95% as assessed by drug accountability. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study and n (number analyzed) signifies subjects analyzed for this outcome measure at specified timepoints. Here, 99999 refers that the data is not available for referred arm.
    End point type
    Secondary
    End point timeframe
    Baseline to Switch and switch to EOE to open-label D/C/F/TAF (Up to 3 years)
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    362
    295
    363
    Units: percentage of subjects
    number (not applicable)
        Baseline to Switch (double-blind) (n=289, 282, 0)
    87.2
    0
    82.6
        Switch to EOE (open-label D/C/F/TAF) (n=231,0,222)
    92.2
    88.7
    99999
    No statistical analyses for this end point

    Secondary: Change From Reference in CD4+ Cell Count

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    End point title
    		 Change From Reference in CD4+ Cell Count [4]
    End point description
    The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from reference in CD4+ cell count at Week 96 were assessed. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Based on NC=F analysis with values after discontinuation imputed with the baseline value. Other (intermittent) missing values are imputed using LOCF. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    362
    289
    Units: cells/mm^3
        least squares mean (standard error)
    228.85 ( 11.951 )
    27.01 ( 9.522 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations due to Adverse Events Through Week 96

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    End point title
    		 Percentage of Subjects With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations due to Adverse Events Through Week 96 [5]
    End point description
    AE is any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize subject and/or may require medical or surgical intervention to prevent one of the outcomes listed above. The ITT analysis set included all the Subjects who were randomized and received at least one dose of study treatment in the study. This endpoint was planned to be reported for participants who received D/C/F/TAF in group 1 and who switched to D/C/F/TAF in group 2.
    End point type
    Secondary
    End point timeframe
    Up to Week 96
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    362
    295
    Units: percentage of subjects
    number (not applicable)
        Grade 3 AEs
    11.6
    3.7
        Grade 4 AEs
    0.8
    1.4
        SAEs
    10.8
    2.7
        Premature discontinuations due to AEs
    2.8
    0.3
    No statistical analyses for this end point

    Secondary: Change From Reference in Serum Creatinine

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    End point title
    		 Change From Reference in Serum Creatinine [6]
    End point description
    Change from reference in serum creatinine was reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    317
    287
    Units: mg/dL
        median (full range (min-max))
    0.045 (-0.25 to 0.30)
    -0.034 (-0.71 to 0.40)
    No statistical analyses for this end point

    Secondary: Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine by Cockcroft-Gault Formula

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    End point title
    		 Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Creatinine by Cockcroft-Gault Formula [7]
    End point description
    Change from reference in eGFRcr by (cockcroft-gault formula) was reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    This endpoint was planned to be reported for participants who received D/C/F/TAF in group 1 and who switched to D/C/F/TAF in group 2.
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    317
    287
    Units: mL/min
        median (full range (min-max))
    -5.2 (-73 to 41)
    4.6 (-47 to 55)
    No statistical analyses for this end point

    Secondary: Change From Reference in eGFRcr by CKD-EPI Formula

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    End point title
    		 Change From Reference in eGFRcr by CKD-EPI Formula [8]
    End point description
    Change from reference in eGFRcr was calculated using the CKD-EPI equation as per Stage 1 (normal or high GFR) to Stage 5 (End Stage of CKD). The ITT analysis set included all the Subjects who were randomized and received at least one dose of study treatment in the study. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    317
    287
    Units: mL/min/1.73 m^2
        median (full range (min-max))
    -5.6 (-33 to 29)
    2.3 (-29 to 43)
    No statistical analyses for this end point

    Secondary: Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula

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    End point title
    		 Change From Reference in Estimated Glomerular Filtration Rate Based on Serum Cystatin C (eGFRcyst) by CKD-EPI Formula [9]
    End point description
    Change from reference in eGFRcyst was calculated using the CKD-EPI equation as per Stage 1 (normal or high GFR) to Stage 5 (End Stage of CKD): <15 mL/min indicate very severe or end stage kidney failure. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    22
    33
    Units: mL/min/1.73 m^2
        median (full range (min-max))
    4.4 (-14 to 37)
    0 (-12 to 26)
    No statistical analyses for this end point

    Secondary: Change From Reference in UPCR

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    End point title
    		 Change From Reference in UPCR [10]
    End point description
    Change from reference in UPCR was reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    312
    287
    Units: mg/g
        median (full range (min-max))
    -15.46 (-728.7 to 197.9)
    -1.40 (-705.7 to 289.2)
    No statistical analyses for this end point

    Secondary: Change From Reference in URBPCR

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    End point title
    		 Change From Reference in URBPCR [11]
    End point description
    Change from references in URBPCR was reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    313
    285
    Units: mcg/g
        median (full range (min-max))
    13.70 (-1555.1 to 2547.1)
    -35.53 (-108886.3 to 291.3)
    No statistical analyses for this end point

    Secondary: Change From Reference in UACR

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    End point title
    		 Change From Reference in UACR [12]
    End point description
    Change from reference in UACR were reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    317
    287
    Units: mg/g
        median (full range (min-max))
    -0.70 (-288.1 to 44.5)
    -0.49 (-294.5 to 583.2)
    No statistical analyses for this end point

    Secondary: Change From Reference in UB2MGCR

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    End point title
    		 Change From Reference in UB2MGCR [13]
    End point description
    Change from reference in UB2MGCR was reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    310
    286
    Units: mcg/g
        median (full range (min-max))
    -27.04 (-11704.6 to 894.7)
    -40.53 (-111778.9 to 624.6)
    No statistical analyses for this end point

    Secondary: Percent Change From Reference in Hip and Spine BMD

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    End point title
    		 Percent Change From Reference in Hip and Spine BMD [14]
    End point description
    The BMD is the amount of mineral in gram per square centimeter of bone, which was assessed by DEXA scan. Positive values are "best v" and negative values are "worst values" of change. Percent change from references in hip and spine BMD was assessed. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and n (number analyzed) signifies subjects analyzed for this endpoint at specified timepoints. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    113
    83
    Units: Percent change in BMD
    arithmetic mean (standard error)
        Hip region BMD n= 87, 71
    -0.2565 ( 0.35599 )
    0.5467 ( 0.38512 )
        Spine region BMD n= 86, 71
    -0.9349 ( 0.44599 )
    0.4829 ( 0.39270 )
    No statistical analyses for this end point

    Secondary: Percent Change From Reference in Urine FEPO4

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    End point title
    		 Percent Change From Reference in Urine FEPO4 [15]
    End point description
    Percent change from references in FEPO4 were reported. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    316
    286
    Units: Percent change in urine FEPO4
        median (full range (min-max))
    18.52 (-84.2 to 1170.1)
    -7.51 (-83.5 to 494.7)
    No statistical analyses for this end point

    Secondary: Change From Reference in BMD T-score of Hip and Spine at Week 96

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    End point title
    		 Change From Reference in BMD T-score of Hip and Spine at Week 96 [16]
    End point description
    BMD status was assessed using BMD T-scores; normal bone status was defined by a BMD T-score >= -1, osteopenia by a T-score >= -2.5 to <-1.0, and osteoporosis by a T-score <-2.5. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint and n (number analyzed) signifies subjects analyzed for this endpoint at specified timepoints. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    87
    71
    Units: BMD T-score
    arithmetic mean (standard error)
        Hip region BMD T-score (n=87, 71)
    -0.016 ( 0.0245 )
    0.025 ( 0.0272 )
        Spine region BMD T-score (n=86, 71)
    -0.090 ( 0.0407 )
    0.034 ( 0.0355 )
    No statistical analyses for this end point

    Secondary: Change From Reference in ALP Levels

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    End point title
    		 Change From Reference in ALP Levels [17]
    End point description
    Change from references in ALP levels was reported. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    92
    80
    Units: U/L
        arithmetic mean (standard error)
    -0.9 ( 1.23 )
    -9.7 ( 1.55 )
    No statistical analyses for this end point

    Secondary: Change From Reference in Levels of Serum P1NP

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    End point title
    		 Change From Reference in Levels of Serum P1NP [18]
    End point description
    Change from reference in serum P1NP levels were reported. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    91
    75
    Units: mcg/L
        arithmetic mean (standard error)
    2.817 ( 1.7140 )
    -11.963 ( 1.7636 )
    No statistical analyses for this end point

    Secondary: Change From Reference in Levels of Serum CTX

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    End point title
    		 Change From Reference in Levels of Serum CTX [19]
    End point description
    Change from reference in serum CTX levels was reported. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    91
    77
    Units: mcg/L
        arithmetic mean (standard error)
    0.041 ( 0.0190 )
    -0.162 ( 0.0190 )
    No statistical analyses for this end point

    Secondary: Change From Reference in Levels of PTH

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    End point title
    		 Change From Reference in Levels of PTH [20]
    End point description
    Change from reference in PTH levels was reported. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    90
    77
    Units: pmol/L
        arithmetic mean (standard error)
    -0.290 ( 0.2078 )
    -1.283 ( 0.2483 )
    No statistical analyses for this end point

    Secondary: Change From Reference in Levels of 25-OH Vitamin D

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    End point title
    		 Change From Reference in Levels of 25-OH Vitamin D [21]
    End point description
    Change from reference in 25-OH Vitamin D levels were reported. BIS analysis set included all subjects who were randomized, received at least 1 dose of study drug in study and had at least one post-baseline value for either biomarker/BMD data. Here, reference 1 is the comparative phase baseline value in Week 48 analysis for test group and reference 2 is the last value prior to the switch for Control group and N (number of subjects analyzed) signifies subjects evaluated for this endpoint. This endpoint was planned to be reported for participants who received D/C/F/TAF in Test group and who switched to D/C/F/TAF in Switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Reference 1 to Week 96 for D/C/F/TAF Group and Reference 2 to Week 96 for Switch to D/C/F/TAF
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    91
    77
    Units: nmol/L
        arithmetic mean (standard error)
    21.3 ( 2.45 )
    -10.3 ( 2.87 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to end of Extension

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    End point title
    		 Percentage of Subjects With HIV RNA <50, <20, and <200 Copies/mL Post-week 96 to end of Extension [22]
    End point description
    Percentage of subjects with HIV RNA <50, <20, and <200 copies/mL post week 96 to end of extension were reported. The ITT analysis set included all the Subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint and n (number analyzed) signifies subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Week 96 to end of extension (up to 3 years)
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    303
    296
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 96 + 6 months (<50 copies/mL) n= 303, 296
    97.7 (95.3 to 99.1)
    96.3 (93.4 to 98.1)
        Week 96 + 12 months (<50 copies/mL) n= 194, 214
    99.0 (96.3 to 99.9)
    96.7 (93.4 to 98.7)
        Week 96 + 18 months (<50 copies/mL) n= 158, 167
    98.1 (94.6 to 99.6)
    98.2 (94.8 to 99.6)
        Week 96 + 24 months (<50 copies/mL) n= 81, 92
    97.5 (91.4 to 99.7)
    95.7 (89.2 to 98.8)
        Week 96 + 30 months (<50 copies/mL) n= 57, 58
    94.7 (85.4 to 98.9)
    91.4 (81.0 to 97.1)
        Week 96 + 36 months (<50 copies/mL) n= 19, 16
    100.0 (82.4 to 100.0)
    68.8 (41.3 to 89.0)
        Week 96 + 6 months (<20 copies/mL) n= 303, 296
    85.8 (81.4 to 89.5)
    88.2 (83.9 to 91.6)
        Week 96 + 12 months (<20 copies/mL) n= 194, 214
    89.7 (84.5 to 93.6)
    91.6 (87.0 to 94.9)
        Week 96 + 18 months (<20 copies/mL) n= 158, 167
    92.4 (87.1 to 96.0)
    92.8 (87.8 to 96.2)
        Week 96 + 24 months (<20 copies/mL) n= 81, 92
    90.1 (81.5 to 95.6)
    87.0 (78.3 to 93.1)
        Week 96 + 30 months (<20 copies/mL) n= 57, 58
    89.5 (78.5 to 96.0)
    84.5 (72.6 to 92.7)
        Week 96 + 36 months (<20 copies/mL) n= 19, 16
    94.7 (74.0 to 99.9)
    62.5 (35.4 to 84.8)
        Week 96 + 6 months (<200 copies/mL) n= 303, 296
    99.7 (98.2 to 100.0)
    99.3 (97.6 to 99.9)
        Week 96 + 12 months (<200 copies/mL) n= 194, 214
    100.0 (98.1 to 100.0)
    99.5 (97.4 to 100)
        Week 96 + 18 months (<200 copies/mL) n= 158, 167
    98.7 (95.5 to 99.8)
    98.2 (94.8 to 99.6)
        Week 96 + 24 months (<200 copies/mL) n= 81, 92
    97.5 (91.4 to 99.7)
    97.8 (92.4 to 99.7)
        Week 96 + 30 months (<200 copies/mL) n= 57, 58
    96.5 (87.9 to 99.6)
    98.3 (90.8 to 100.0)
        Week 96 + 36 months (<200 copies/mL) n= 19, 16
    100.0 (82.4 to 100.0)
    87.5 (61.7 to 98.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Protocol-defined Virologic Failure (PDVF)

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    End point title
    		 Percentage of Subjects with Protocol-defined Virologic Failure (PDVF)
    End point description
    Percentage of subjects with PDVF were reported. PDVF was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here N (number of participants analyzed) refers to 311 for test group and 310 for switch to D/C/F/TAF group. Here,99999 refers that the data is not applicable for the respective arm as specified below because data of Baseline to Week 96 is applicable for Test group, Baseline to switch applicable for Control group and Switch to Week 96 is applicable to switch to D/C/F/TAF group.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 96
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    362
    295
    363
    Units: percentage of subject
    number (not applicable)
        Subjects who met PDVF (Baseline - Week 96)
    4.1
    99999
    99999
        Virologic non-response (Baseline - Week 96)
    0.6
    99999
    99999
        Virologic rebound (Baseline-Week 96)
    0.3
    99999
    99999
        Viremic at final time point (Baseline-Week 96)
    0.6
    99999
    99999
        Subjects who met PDVF (Baseline - Switch)
    99999
    99999
    4.4
        Virologic non-response (Baseline - Switch)
    99999
    99999
    0
        Virologic rebound (Baseline - Switch)
    99999
    99999
    3.9
        Viremic at final time point (Baseline - Switch)
    99999
    99999
    0.6
        Subjects who met PDVF (Switch - Week 96)
    99999
    1.1
    99999
        Virologic non-response (Switch - Week 96)
    99999
    0
    99999
        Virologic rebound (Switch - Week 96)
    99999
    1.1
    99999
        Viremic at final time point (Switch - Week 96)
    99999
    0
    99999
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with PDVF Post-week 96 to End of Extension

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    End point title
    		 Percentage of Subjects with PDVF Post-week 96 to End of Extension [23]
    End point description
    Percentage of subjects with PDVF were reported. PDVF was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). The ITT analysis set included all the Subjects who were randomized and received at least one dose of study treatment in the study.
    End point type
    Secondary
    End point timeframe
    Week 96 to end of extension (up to 3 years)
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    311
    310
    Units: percentage of subject
    number (not applicable)
        Subjects who met PDVF
    1.0
    2.1
        Virologic non-response
    0
    0
        Virologic rebound
    1.0
    1.4
        Viremic at final time point
    0
    0.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants with non-PDVF by Kaplan-Meier Estimates

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    End point title
    		 Percentage of Participants with non-PDVF by Kaplan-Meier Estimates [24]
    End point description
    Percentage of participants with non-PDVF by Kaplan-Meier Estimates were reported. PDVF was defined as having virologic non-response (HIV-1 RNA <1 log10 reduction from baseline and >=50 copies/mL at the Week 8 visit, confirmed at the next visit), virologic rebound (confirmed HIV-1 RNA >=50 copies/mL after confirmed consecutive HIV-1 RNA <50 copies/mL or confirmed >1 log10 increase in HIV-1 RNA from nadir), or viremic at final time point (final available on treatment HIV-1 RNA >=400 copies/mL). The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study.
    End point type
    Secondary
    End point timeframe
    From Week 96 to end of extension (up to 2 years and 6 months)
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    311
    310
    Units: percentage of subjects
    number (confidence interval 95%)
        Week 96
    100 (100 to 100)
    100 (100 to 100)
        Week 96 + 6 months
    99.6 (97.2 to 99.9)
    99.2 (97.0 to 99.8)
        Week 96 + 12 months
    99.6 (97.2 to 99.9)
    99.2 (97.2 to 99.8)
        Week 96 + 18 months
    98.6 (94.0 to 99.7)
    97.8 (94.1 to 99.2)
        Week 96 + 24 months
    97.3 (91.0 to 99.2)
    97.8 (94.1 to 99.2)
        Week 96 + 30 months
    97.3 (91.0 to 99.2)
    92.5 (79.8 to 97.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with time to Treatment Failure by Kaplan-Meier Estimates

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    End point title
    		 Percentage of Participants with time to Treatment Failure by Kaplan-Meier Estimates [25]
    End point description
    Percentage of participants with time to treatment failure by Kaplan-Meier Estimates were reported. Treatment failure was defined as having either protocol-defined virologic failure or having discontinued for reasons other than alternate access to D/C/F/TAF (or other ARVs). The ITT analysis set included all the Subjects who were randomized and received at least one dose of study treatment in the study. Here, 99999 stands for data not available for the referred arm as the participants didn't have treatment failure at this timepoint.
    End point type
    Secondary
    End point timeframe
    From Week 96 to end of extension (up to 3 years)
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    311
    310
    Units: months
    number (confidence interval 95%)
        Week 96
    100 (100 to 100)
    100 (100 to 100)
        Week 96 + 6 months
    98.9 (96.5 to 99.6)
    97.4 (94.5 to 98.7)
        Week 96 + 12 months
    95.6 (91.7 to 97.7)
    94.1 (90.2 to 96.5)
        Week 96 + 18 months
    90.6 (84.9 to 94.2)
    89.5 (84.3 to 93.0)
        Week 96 + 24 months
    87.1 (79.8 to 91.8)
    86.4 (80.0 to 90.9)
        Week 96 + 30 months
    84.8 (75.8 to 90.6)
    79.1 (68.9 to 86.3)
        Week 96 + 36 months
    84.8 (75.8 to 90.6)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: CD4+ Cell Count Post-Week 96 to end of Extension

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    End point title
    		 CD4+ Cell Count Post-Week 96 to end of Extension [26]
    End point description
    The immunologic change was determined by CD4+ cell count. CD4+ cell count post-Week 96 to end of extension were assessed. The ITT analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint and and n (number analyzed) signifies subjects analyzed for this endpoint at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Week 96 to end of extension (up to 3 years)
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    300
    293
    Units: cells/mm^3
    least squares mean (standard error)
        Week 96 + 6 months n= 300, 293
    790.2 ( 17.23 )
    749.7 ( 16.44 )
        Week 96 + 12 months n= 192, 212
    779.4 ( 22.45 )
    774.3 ( 21.91 )
        Week 96 + 18 months n= 154, 165
    789.8 ( 23.43 )
    758.4 ( 23.25 )
        Week 96 + 24 months n= 78, 92
    781.9 ( 37.77 )
    784.1 ( 30.78 )
        Week 96 + 30 months n= 57, 58
    741.6 ( 37.12 )
    736.7 ( 37.47 )
        Week 96 + 36 months n= 18, 16
    784.7 ( 69.74 )
    778.4 ( 86.59 )
    No statistical analyses for this end point

    Secondary: Number of Subjects With ARV Resistance

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    End point title
    		 Number of Subjects With ARV Resistance
    End point description
    Number of subjects with DRV, FTC, TDF/TAF resistance were reported. The ITT analysis set included all the Subjects who were randomized and received at least one dose of study treatment in the study. Here, N (number of subjects analyzed) signifies subjects evaluated for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline to end of extension (up to 4 years)
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Number of subjects analysed
    12
    7
    8
    Units: subjects
        DRV resistance-associated mutations (RAMs)
    0
    0
    0
        TFV RAMs
    0
    0
    0
        FTC RAMs
    2
    2
    1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations due to Adverse Events Post-Week 96 to end of Extension

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    End point title
    		 Percentage of Subjects With Grade 3 and 4 AEs, SAEs, and Premature Discontinuations due to Adverse Events Post-Week 96 to end of Extension [27]
    End point description
    AE is any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events. SAE is any adverse event (AE) that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize subject and/or may require medical or surgical intervention to prevent one of the outcomes listed above. The ITT analysis set included all the Subjects who were randomized and received at least one dose of study treatment in the study.
    End point type
    Secondary
    End point timeframe
    From Week 96 to end of extension (up to 3 years)
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As planned the endpoint is not reporting Stats for all the arms of the baseline period.
    End point values
    		 D/C/F/TAF (Test) (Baseline [BL] to End of Extension [EOE]) Switch to D/C/F/TAF
    Number of subjects analysed
    311
    310
    Units: percentage of subjects
    number (not applicable)
        Grade 3 AEs
    3.5
    5.2
        Grade 4 AEs
    0
    1.3
        SAEs
    3.2
    4.8
        Premature discontinuations due to AEs
    1.0
    1.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 60 months
    Adverse event reporting additional description
    The intent-to-treat (ITT) analysis set included all the subjects who were randomized and received at least one dose of study treatment in the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    D/C/F/TAF (Test) (Baseline to End of Extension [EOE])
    Reporting group description
    		 Subjects received a single oral tablet containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg (D/C/F/TAF fixed dose combination [FDC]) once daily along with DRV/COBI FDC-matching placebo and FTC/tenofovir disoproxil fumarate (TDF) FDC-matching placebo tablets once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48). After Week 48 analysis unblinding visit, all subjects received D/C/F/TAF treatment up to Week 96. After Week 96, subjects were given the opportunity to continue D/C/F/TAF treatment during an extension phase until the D/C/F/TAF FDC tablet became commercially available.

    Reporting group title
    DRV/COBI+ FTC/TDF (Control) (Baseline to Switch)
    Reporting group description
    		 Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily Subjects received DRV 800 mg/COBI 150 mg FDC and FTC 200 mg/TDF 300 mg FDC along with D/C/F/TAF FDC-matching placebo tablet once daily up to Week 48 analysis unblinding visit (that is, after last subject has reached Week 48).

    Reporting group title
    Switch to D/C/F/TAF Group
    Reporting group description
    		 After Week 48 analysis unblinding visit, subjects earlier receiving treatment with DRV/COBI+ FTC/TDF (Control) switched to D/C/F/TAF treatment and continued for up to Week 96 during open-label, single-group treatment phase. After Week 96, subjects were given the opportunity to continue D/C/F/TAF treatment until the D/C/F/TAF FDC tablet became commercially available.

    Serious adverse events
    		 D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) Switch to D/C/F/TAF Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    47 / 362 (12.98%)
    36 / 363 (9.92%)
    21 / 322 (6.52%)
         number of deaths (all causes)
    0
    1
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital Warts
         subjects affected / exposed
    2 / 362 (0.55%)
    2 / 363 (0.55%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal Cell Carcinoma
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hodgkin's Disease
         subjects affected / exposed
    1 / 362 (0.28%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Kaposi's Sarcoma
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of Lung
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Influenza Like Illness
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Cardiac Chest Pain
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular Stent Stenosis
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Alcohol Use
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian Cyst Ruptured
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Testicular Torsion
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine Polyp
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthmatic Crisis
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Borderline Personality Disorder
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug Dependence
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    0 / 362 (0.00%)
    3 / 363 (0.83%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    1 / 362 (0.28%)
    1 / 363 (0.28%)
    2 / 322 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Waist Circumference Increased
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcohol Poisoning
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exposure During Pregnancy
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intentional Overdose
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Road Traffic Accident
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    1 / 362 (0.28%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial Infarction
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness Postural
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Bone Marrow Oedema
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal Fistula
         subjects affected / exposed
    1 / 362 (0.28%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anogenital Dysplasia
         subjects affected / exposed
    2 / 362 (0.55%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis Sclerosing
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 362 (0.00%)
    2 / 363 (0.55%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stevens-Johnson Syndrome
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic Skin Eruption
         subjects affected / exposed
    0 / 362 (0.00%)
    2 / 363 (0.55%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus Urinary
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    1 / 362 (0.28%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal Abscess
         subjects affected / exposed
    2 / 362 (0.55%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    3 / 362 (0.83%)
    2 / 363 (0.55%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium Difficile Colitis
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea Infectious
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    2 / 322 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    3 / 362 (0.83%)
    3 / 363 (0.83%)
    2 / 322 (0.62%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis Viral
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Latent Syphilis
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocarditis Infectious
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mumps
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis Bacterial
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung Abscess
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papilloma Viral Infection
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurosyphilis
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 362 (0.83%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal Abscess
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 362 (0.00%)
    1 / 363 (0.28%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Secondary Syphilis
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethritis
         subjects affected / exposed
    0 / 362 (0.00%)
    0 / 363 (0.00%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syphilis
         subjects affected / exposed
    1 / 362 (0.28%)
    1 / 363 (0.28%)
    1 / 322 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    1 / 362 (0.28%)
    0 / 363 (0.00%)
    0 / 322 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 D/C/F/TAF (Test) (Baseline to End of Extension [EOE]) DRV/COBI+ FTC/TDF (Control) (Baseline to Switch) Switch to D/C/F/TAF Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    284 / 362 (78.45%)
    252 / 363 (69.42%)
    137 / 322 (42.55%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    56 / 362 (15.47%)
    38 / 363 (10.47%)
    11 / 322 (3.42%)
         occurrences all number
    79
    66
    12
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    26 / 362 (7.18%)
    21 / 363 (5.79%)
    1 / 322 (0.31%)
         occurrences all number
    29
    24
    1
    Asthenia
         subjects affected / exposed
    21 / 362 (5.80%)
    15 / 363 (4.13%)
    4 / 322 (1.24%)
         occurrences all number
    21
    16
    4
    Pyrexia
         subjects affected / exposed
    20 / 362 (5.52%)
    24 / 363 (6.61%)
    6 / 322 (1.86%)
         occurrences all number
    22
    28
    6
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    89 / 362 (24.59%)
    72 / 363 (19.83%)
    18 / 322 (5.59%)
         occurrences all number
    143
    91
    20
    Nausea
         subjects affected / exposed
    34 / 362 (9.39%)
    46 / 363 (12.67%)
    8 / 322 (2.48%)
         occurrences all number
    39
    56
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    20 / 362 (5.52%)
    15 / 363 (4.13%)
    7 / 322 (2.17%)
         occurrences all number
    24
    16
    7
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    37 / 362 (10.22%)
    25 / 363 (6.89%)
    9 / 322 (2.80%)
         occurrences all number
    44
    26
    9
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    19 / 362 (5.25%)
    9 / 363 (2.48%)
    5 / 322 (1.55%)
         occurrences all number
    21
    10
    5
    Insomnia
         subjects affected / exposed
    20 / 362 (5.52%)
    13 / 363 (3.58%)
    5 / 322 (1.55%)
         occurrences all number
    24
    14
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    20 / 362 (5.52%)
    17 / 363 (4.68%)
    11 / 322 (3.42%)
         occurrences all number
    25
    20
    12
    Back Pain
         subjects affected / exposed
    31 / 362 (8.56%)
    10 / 363 (2.75%)
    16 / 322 (4.97%)
         occurrences all number
    36
    11
    18
    Osteopenia
         subjects affected / exposed
    19 / 362 (5.25%)
    29 / 363 (7.99%)
    0 / 322 (0.00%)
         occurrences all number
    20
    32
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    24 / 362 (6.63%)
    25 / 363 (6.89%)
    20 / 322 (6.21%)
         occurrences all number
    32
    30
    22
    Chlamydial Infection
         subjects affected / exposed
    23 / 362 (6.35%)
    9 / 363 (2.48%)
    2 / 322 (0.62%)
         occurrences all number
    27
    9
    2
    Gastroenteritis
         subjects affected / exposed
    28 / 362 (7.73%)
    15 / 363 (4.13%)
    5 / 322 (1.55%)
         occurrences all number
    32
    15
    5
    Gonorrhoea
         subjects affected / exposed
    21 / 362 (5.80%)
    14 / 363 (3.86%)
    5 / 322 (1.55%)
         occurrences all number
    31
    15
    6
    Pharyngitis
         subjects affected / exposed
    31 / 362 (8.56%)
    19 / 363 (5.23%)
    7 / 322 (2.17%)
         occurrences all number
    34
    24
    7
    Nasopharyngitis
         subjects affected / exposed
    64 / 362 (17.68%)
    38 / 363 (10.47%)
    19 / 322 (5.90%)
         occurrences all number
    102
    58
    23
    Respiratory Tract Infection
         subjects affected / exposed
    20 / 362 (5.52%)
    14 / 363 (3.86%)
    8 / 322 (2.48%)
         occurrences all number
    28
    22
    11
    Upper Respiratory Tract Infection
         subjects affected / exposed
    40 / 362 (11.05%)
    30 / 363 (8.26%)
    26 / 322 (8.07%)
         occurrences all number
    55
    42
    43
    Syphilis
         subjects affected / exposed
    41 / 362 (11.33%)
    25 / 363 (6.89%)
    24 / 322 (7.45%)
         occurrences all number
    51
    29
    27
    Metabolism and nutrition disorders
    Vitamin D Deficiency
         subjects affected / exposed
    28 / 362 (7.73%)
    16 / 363 (4.41%)
    6 / 322 (1.86%)
         occurrences all number
    32
    16
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2015
    The overall reason for the amendment was that, following Health Authority feedback, the creatinine clearance threshold for eligibility was increased from 50 to 70 milliliters per minute (mL/min) and subjects previously treated with post-exposure prophylaxis and/or pre-exposure prophylaxis were no longer allowed in the study.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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