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    Clinical Trial Results:
    A Phase 3b, Randomized, Open-Label Study to Evaluate Switching from a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 60 Years

    Summary
    EudraCT number
    		 2015-002712-32
    Trial protocol
    		 GB   BE   ES   FR   IT  
    Global end of trial date
    21 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2019
    First version publication date
    16 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-292-1826
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02616783
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by assessing spine and hip bone mineral density (BMD) measured at Week 48 in virologically-suppressed, HIV-1 infected participants aged ≥ 60 years.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Dec 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 52
    Country: Number of subjects enrolled
    Spain: 43
    Country: Number of subjects enrolled
    United Kingdom: 11
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    France: 52
    Worldwide total number of subjects
    167
    EEA total number of subjects
    167
    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)
    83
    From 65 to 84 years
    84
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Europe. The first participant was screened on 22 December 2015. The last study visit occurred on 21 March 2018.

    Pre-assignment
    Screening details
    		 214 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 E/C/F/TAF
    Arm description
    		 Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
    Investigational medicinal product code
    Other name
    E/C/F/TAF, Genvoya®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily

    Arm title
    		 Stay on Baseline Regimen
    Arm description
    		 Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    TDF, Viread®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg administered once daily

    Investigational medicinal product name
    Emtricitabine
    Investigational medicinal product code
    Other name
    FTC, Emtriva®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg administered once daily

    Investigational medicinal product name
    3TC
    Investigational medicinal product code
    Other name
    Lamivudine, Epivir®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once daily

    Investigational medicinal product name
    Third Agent
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Third agent may have included one of the following regimens: lopinavir+ritonavir (LPV/r; Kaletra®), atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®), ATV + cobicistat (COBI;Tybost®) (or ATV/COBI FDC), DRV + RTV, darunavir (DRV; Prezista®) + COBI (or DRV/COBI FDC), fosamprenavir (FPV; Lexiva®) + RTV , saquinavir (SQV; Invirase®; Fortovase®) + RTV, efavirenz (EFV;Sustiva®), rilpivirine (RPV;Edurant®), nevirapine (NVP;Viramune®), etravirine (ETR;Intelence®), raltegravir (RAL; Isentress®), elvitegravir (EVG) + COBI, or dolutegravir (DTG;Tivicay®)

    Number of subjects in period 1 [1]
    		E/C/F/TAF Stay on Baseline Regimen
    Started
    110
    56
    Completed
    105
    54
    Not completed
    5
    2
         Withdrew Consent
    1
    1
         Non-Compliance with Study Drug
    1
    -
         Adverse event, non-fatal
    1
    -
         Death
    1
    -
         Protocol Violation
    1
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant who was randomized but not treated is not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    E/C/F/TAF
    Reporting group description
    		 Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.

    Reporting group title
    Stay on Baseline Regimen
    Reporting group description
    		 Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.

    Reporting group values
    		 E/C/F/TAF Stay on Baseline Regimen Total
    Number of subjects
    		 110 56 166
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 65 ± 4.6 66 ± 4.9 -
    Gender categorical
    Units: Subjects
        Female
    		 14 5 19
        Male
    		 96 51 147
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 16 8 24
        Not Hispanic or Latino
    		 88 42 130
        Not Permitted
    		 6 6 12
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 1 1
        Black or African American
    		 2 2 4
        White
    		 103 49 152
        Not Permitted
    		 5 4 9
    HIV-1 RNA Category
    Units: Subjects
        < 50 copies/ mL
    		 109 56 165
        ≥ 50 copies/ mL
    		 1 0 1
    CD4+ Cell Count Category
    Units: Subjects
        ≥ 50 to < 200 cells/μL
    		 0 2 2
        ≥ 200 to < 350 cells/μL
    		 12 8 20
        ≥ 350 to < 500 cells/μL
    		 18 7 25
        ≥ 500 cells/ μL
    		 80 39 119
    CD4+ Cell Count
    Units: cells/μL
        arithmetic mean (standard deviation)
    		 649 ± 255.6 676 ± 316.5 -
    Spine Bone Mineral Density (BMD)
    The Spine Dual-Energy X-ray Absorptiometry (DXA) Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, had non missing screening spine BMD values, and did not have any major protocol violations (E/C/F/TAF; N = 109; Stay on Baseline Regimen: N = 55).
    Units: g/cm^2
        arithmetic mean (standard deviation)
    		 1.036 ± 0.1886 1.052 ± 0.1789 -
    Hip BMD
    The Hip DXA Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, had non missing screening hip BMD values, and did not have any major protocol violations (E/C/F/TAF: N = 109; Stay on Baseline Regimen: N = 55).
    Units: g/cm^2
        arithmetic mean (standard deviation)
    		 0.922 ± 0.1332 0.927 ± 0.1346 -

    End points

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    End points reporting groups
    Reporting group title
    E/C/F/TAF
    Reporting group description
    		 Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.

    Reporting group title
    Stay on Baseline Regimen
    Reporting group description
    		 Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.

    Primary: Percent Change From Baseline to Week 48 in Spine BMD

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    End point title
    		 Percent Change From Baseline to Week 48 in Spine BMD
    End point description
    Participants in the Spine DXA Analysis Set with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline; Week 48
    End point values
    		 E/C/F/TAF Stay on Baseline Regimen
    Number of subjects analysed
    102
    54
    Units: Percent change
        arithmetic mean (standard deviation)
    2.237 ± 3.2727
    -0.104 ± 3.3854
    Statistical analysis title
    		 Percent Change in Spine BMD at Week 48
    Comparison groups
    E/C/F/TAF v Stay on Baseline Regimen
    Number of subjects included in analysis
    156
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [1]
    Method
    		 ANOVA
    Parameter type
    		 Difference in Percentages
    Point estimate
    2.427
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.337
         upper limit
    		 3.517
    Notes
    [1] - P-value and 95% confidence intervals (CI) were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.

    Primary: Percent Change From Baseline to Week 48 in Hip BMD

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    End point title
    		 Percent Change From Baseline to Week 48 in Hip BMD
    End point description
    Participants in the Hip DXA Analysis Set with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Baseline; Week 48
    End point values
    		 E/C/F/TAF Stay on Baseline Regimen
    Number of subjects analysed
    101
    54
    Units: Percent change
        arithmetic mean (standard deviation)
    1.330 ± 2.1968
    -0.726 ± 3.2069
    Statistical analysis title
    		 Percent Change in Hip BMD at Week 48
    Comparison groups
    Stay on Baseline Regimen v E/C/F/TAF
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 ANOVA
    Parameter type
    		 Difference in percentages
    Point estimate
    2.036
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.168
         upper limit
    		 2.904
    Notes
    [2] - P-value and 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.

    Secondary: Percent Change From Baseline to Week 24 in Spine BMD

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    End point title
    		 Percent Change From Baseline to Week 24 in Spine BMD
    End point description
    Participants in the Spine DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 E/C/F/TAF Stay on Baseline Regimen
    Number of subjects analysed
    104
    54
    Units: Percent change
        arithmetic mean (standard deviation)
    1.625 ± 3.2346
    -0.027 ± 2.9875
    Statistical analysis title
    		 Percent Change in Spine BMD at Week 24
    Comparison groups
    E/C/F/TAF v Stay on Baseline Regimen
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [3]
    Method
    		 ANOVA
    Parameter type
    		 Difference in percentages
    Point estimate
    1.749
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.726
         upper limit
    		 2.771
    Notes
    [3] - P-value and 95% CIs were calculated using the ANOVA model with baseline spine BMD score, sex, and treatment as fixed effects.

    Secondary: Percent Change From Baseline to Week 24 in Hip BMD

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    End point title
    		 Percent Change From Baseline to Week 24 in Hip BMD
    End point description
    Participants in the Hip DXA Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 E/C/F/TAF Stay on Baseline Regimen
    Number of subjects analysed
    103
    54
    Units: Percent change
        arithmetic mean (standard deviation)
    0.808 ± 1.9084
    -0.537 ± 2.7647
    Statistical analysis title
    		 Percent Change in Hip BMD at Week 24
    Comparison groups
    E/C/F/TAF v Stay on Baseline Regimen
    Number of subjects included in analysis
    157
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [4]
    Method
    		 ANOVA
    Parameter type
    		 Difference in percentages
    Point estimate
    1.351
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.602
         upper limit
    		 2.099
    Notes
    [4] - P-value and 95% CIs were calculated using the ANOVA model with baseline hip BMD score, sex, and treatment as fixed effects.

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and did not have any major protocol violations.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 E/C/F/TAF Stay on Baseline Regimen
    Number of subjects analysed
    109
    55
    Units: percentage of participants
        number (not applicable)
    94.5
    100.0
    Statistical analysis title
    		 Statistical Analysis - E/C/F/TAF vs SBR
    Comparison groups
    E/C/F/TAF v Stay on Baseline Regimen
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.18 [5]
    Method
    		 Fisher exact
    Parameter type
    		 Difference in percentages
    Point estimate
    -5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.8
         upper limit
    		 1.6
    Notes
    [5] - P-values for the superiority test comparing the percentages of participants with HIV-1 RNA < 50 copies/mL were from the Fisher exact test. Differences in percentages and 95% CI were generated based on exact method.

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Full Analysis Set included all participants who were randomized into the study, received at least 1 dose of study drug, and did not have any major protocol violations.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 E/C/F/TAF Stay on Baseline Regimen
    Number of subjects analysed
    109
    55
    Units: percentage of participants
        number (not applicable)
    93.6
    94.5
    Statistical analysis title
    		 Statistical Analysis - E/C/F/TAF vs SBR
    Comparison groups
    E/C/F/TAF v Stay on Baseline Regimen
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1 [6]
    Method
    		 Fisher exact
    Parameter type
    		 Difference in percentages
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.5
         upper limit
    		 9.3
    Notes
    [6] - P-values for the superiority test comparing the percentages of participants with HIV-1 RNA < 50 copies/mL were from the Fisher exact test. Differences in percentages and 95% CI were generated based on exact method.

    Secondary: Change From Baseline in CD4+ Cell Count at Week 24

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    End point title
    		 Change From Baseline in CD4+ Cell Count at Week 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 E/C/F/TAF Stay on Baseline Regimen
    Number of subjects analysed
    99
    54
    Units: cells/μL
        arithmetic mean (standard deviation)
    48 ± 161.9
    -4 ± 153.9
    Statistical analysis title
    		 Statistical Analysis - E/C/F/TAF vs SBR
    Comparison groups
    E/C/F/TAF v Stay on Baseline Regimen
    Number of subjects included in analysis
    153
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.053 [7]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 106
    Notes
    [7] - The p-value, difference in least square means (LSM), and its 95% CI were from ANOVA model with treatment as a fixed effect.

    Secondary: Change in Baseline in CD4+ Cell Count at Week 48

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    End point title
    		 Change in Baseline in CD4+ Cell Count at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48
    End point values
    		 E/C/F/TAF Stay on Baseline Regimen
    Number of subjects analysed
    102
    50
    Units: cells/μL
        arithmetic mean (standard deviation)
    56 ± 177.7
    -1 ± 149.1
    Statistical analysis title
    		 Statistical Analysis - E/C/F/TAF vs SBR
    Comparison groups
    E/C/F/TAF v Stay on Baseline Regimen
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.051 [8]
    Method
    		 ANOVA
    Parameter type
    		 Difference in LSM
    Point estimate
    57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 115
    Notes
    [8] - The p-value, difference in LSM, and its 95% CI were from ANOVA model with treatment as a fixed effect.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 48 weeks plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set included participants who were randomized into the study and received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    E/C/F/TAF
    Reporting group description
    		 Participants switched from TDF and FTC or 3TC plus a third agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily for 48 weeks.

    Reporting group title
    Stay on Baseline Regimen
    Reporting group description
    		 Participants stayed on current regimen of TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent for 48 weeks.

    Serious adverse events
    		 E/C/F/TAF Stay on Baseline Regimen
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 110 (9.09%)
    1 / 56 (1.79%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colorectal cancer
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 110 (0.91%)
    1 / 56 (1.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuritis cranial
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatomegaly
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Escherichia sepsis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 56 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 E/C/F/TAF Stay on Baseline Regimen
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 110 (42.73%)
    20 / 56 (35.71%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    7 / 110 (6.36%)
    1 / 56 (1.79%)
         occurrences all number
    7
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 110 (7.27%)
    2 / 56 (3.57%)
         occurrences all number
    10
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 110 (5.45%)
    0 / 56 (0.00%)
         occurrences all number
    6
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    9 / 110 (8.18%)
    2 / 56 (3.57%)
         occurrences all number
    9
    2
    Arthralgia
         subjects affected / exposed
    6 / 110 (5.45%)
    4 / 56 (7.14%)
         occurrences all number
    6
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 110 (10.91%)
    3 / 56 (5.36%)
         occurrences all number
    12
    4
    Bronchitis
         subjects affected / exposed
    4 / 110 (3.64%)
    6 / 56 (10.71%)
         occurrences all number
    4
    6
    Urinary tract infection
         subjects affected / exposed
    4 / 110 (3.64%)
    3 / 56 (5.36%)
         occurrences all number
    8
    4
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    7 / 110 (6.36%)
    4 / 56 (7.14%)
         occurrences all number
    7
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Jun 2016
    Revised eligibility criteria to allow additional subjects to enroll in the study without affecting overall risk/benefit ratio.

    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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