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    Clinical Trial Results:
    A Phase 3b Open-Label Pilot Study to Evaluate Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) in Virologically-Suppressed HIV-1 Infected Adult Subjects Harboring the Archived Isolated NRTI Resistance Mutation M184V/M184I

    Summary
    EudraCT number
    		 2015-002710-74
    Trial protocol
    		 ES   DE   IT  
    Global end of trial date
    11 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jul 2020
    First version publication date
    25 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-292-1824
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02616029
    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
    11 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) after switching from a stable regimen consisting of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC) plus a third antiretroviral (ARV) agent in participants harboring the archived nucleoside/nucleotide reverse transcriptase inhibitor (NRTI) resistance mutation M184V and/or M184I in human immunodeficiency virus (HIV)-1 reverse transcriptase. This was a two part study. As the virologic failure in Part 1 was deemed acceptable and the internal data monitoring committee officially completed the interim review, the study was continued to Part 2.
    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
    17 Dec 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
    France: 30
    Country: Number of subjects enrolled
    Spain: 17
    Country: Number of subjects enrolled
    United States: 8
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Italy: 5
    Worldwide total number of subjects
    66
    EEA total number of subjects
    58
    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)
    61
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 17 December 2015. The last study visit occurred on 11 July 2019.

    Pre-assignment
    Screening details
    		 120 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part 1: E/C/F/TAF
    Arm description
    		 Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    E/C/F/TAF FDC
    Investigational medicinal product code
    Other name
    Genvoya®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150/150/200/10 mg administered once daily

    Arm title
    		 Part 2: E/C/F/TAF
    Arm description
    		 Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 thymidine analog-associated mutations (TAMs) switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    E/C/F/TAF FDC
    Investigational medicinal product code
    Other name
    Genvoya®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150/150/200/10 mg administered once daily

    Number of subjects in period 1 [1]
    		Part 1: E/C/F/TAF Part 2: E/C/F/TAF
    Started
    37
    27
    Completed
    34
    26
    Not completed
    3
    1
         Withdrew Consent
    1
    -
         Adverse Event
    1
    -
         Death
    -
    1
         Protocol Violation
    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: Two participants (1 in Part 1 and 1 in Part 2) who were enrolled but did not receive the study drug are not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part 1: E/C/F/TAF
    Reporting group description
    		 Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.

    Reporting group title
    Part 2: E/C/F/TAF
    Reporting group description
    		 Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 thymidine analog-associated mutations (TAMs) switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.

    Reporting group values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total
    Number of subjects
    		 37 27 64
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50 ( 9.2 ) 52 ( 9.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 9 17
        Male
    		 29 18 47
    Ethnicity
    For participants in Not Permitted category: local regulators did not allow collection of ethnicity information.
    Units: Subjects
        Hispanic or Latino
    		 6 4 10
        Not Hispanic or Latino
    		 27 21 48
        Not Permitted
    		 4 2 6
    Race
    For participants in the Not Permitted category: local regulators did not allow collection of race information.
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Black
    		 7 8 15
        Native Hawaiian or Pacific Islander
    		 0 0 0
        White
    		 27 17 44
        Not Permitted
    		 3 2 5
    HIV-1 RNA Categories
    Units: Subjects
        < 50 copies/mL
    		 37 27 64
        >= 50 copies/mL
    		 0 0 0
    Cluster Determinant 4+ (CD4+) Cell Count Categories
    Units: Subjects
        < 50 cells/µL
    		 0 0 0
        >= 50 to < 200 cells/µL
    		 1 2 3
        >= 200 to < 350 cells/µL
    		 3 1 4
        >= 350 to < 500 cells/µL
    		 4 5 9
        >= 500 cells/µL
    		 29 19 48
    HIV Disease Status
    Units: Subjects
        Asymptomatic
    		 30 23 53
        Symptomatic HIV Infection
    		 4 1 5
        Acquired Immune Deficiency Syndrome (AIDS)
    		 3 3 6
    HIV-1 RNA
    Units: log10 copies/mL
        arithmetic mean (standard deviation)
    		 1.29 ( 0.056 ) 1.29 ( 0.046 ) -
    CD4 Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    		 740 ( 319.6 ) 665 ( 312.7 ) -
    CD4 Percentage (%)
    Units: percentage of CD4 cells
        arithmetic mean (standard deviation)
    		 32.9 ( 10.12 ) 31.2 ( 11.43 ) -

    End points

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    End points reporting groups
    Reporting group title
    Part 1: E/C/F/TAF
    Reporting group description
    		 Participants with M184V and/or M184I mutations in reverse transcriptase and without any other NRTI-resistance mutation switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.

    Reporting group title
    Part 2: E/C/F/TAF
    Reporting group description
    		 Participants with M184V and/or M184I mutations in reverse transcriptase and with or without 1 or 2 thymidine analog-associated mutations (TAMs) switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.

    Subject analysis set title
    Total E/C/F/TAF
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants switched from their current HIV treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.

    Primary: Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR)

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    End point title
    		 Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 12 as Defined by Pure Virologic Response (PVR) [1]
    End point description
    The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 12 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. The Full Analysis Set included all the randomized participants who received at least one dose of study drug and excluded participants with any major protocol violations.
    End point type
    Primary
    End point timeframe
    Week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No formal statistical hypotheses were tested for the primary end point.
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (90.3 to 100.0)
    100.0 (86.8 to 100.0)
    100.0 (94.2 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase

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    End point title
    		 Percentage of Participants With Emergence of New Mutations in HIV-1 Reverse Transcriptase and Integrase
    End point description
    Development of new resistance mutations was assessed in participants who developed virologic failure, defined as 2 consecutive HIV-1 RNA result ≥ 50 copies/mL at any point in the study or with HIV-1 RNA ≥ 50 copies/mL at last visit. Participants in the Full Analysis Set were included in the analysis.
    End point type
    Secondary
    End point timeframe
    Day 1 up to Week 48
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using PVR

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using PVR
    End point description
    The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 24 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (90.3 to 100.0)
    100.0 (86.8 to 100.0)
    100.0 (94.2 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using PVR
    End point description
    The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. PVR was the percentage of participants who did not have a confirmed virologic rebound. Virologic rebound was defined as 2 consecutive HIV-1 RNA values ≥ 50 copies/mL or the last available HIV-1 RNA value ≥ 50 copies/mL during the study followed by premature discontinuation from the study. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (90.3 to 100.0)
    100.0 (86.8 to 100.0)
    100.0 (94.2 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the FDA Snapshot Analysis
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was also 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. Week 12 window was between Day 71 and 98 (inclusive). Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    91.7 (77.5 to 98.2)
    96.2 (80.4 to 99.9)
    93.5 (84.3 to 98.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the FDA Snapshot Analysis
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was also 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. Week 24 window was between Day 141 and 210 (inclusive). Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    91.7 (77.5 to 98.2)
    100.0 (86.8 to 100.0)
    95.2 (86.5 to 99.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA Snapshot Analysis
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was also 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. Week 12 window was between Day 295 and 378 (inclusive). Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    88.9 (73.9 to 96.9)
    96.2 (80.4 to 99.9)
    91.9 (82.2 to 97.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 12 Using the FDA Snapshot Analysis

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 12 Using the FDA Snapshot Analysis
    End point description
    The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 12 was also 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. Week 12 window was between Day 71 and 98 (inclusive). Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    91.7 (77.5 to 98.2)
    96.2 (80.4 to 99.9)
    93.5 (84.3 to 98.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 24 Using the FDA Snapshot Analysis

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 24 Using the FDA Snapshot Analysis
    End point description
    The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 24 was also 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. Week 24 window was between Day 141 and 210 (inclusive). Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    88.9 (73.9 to 96.9)
    100.0 (86.8 to 100.0)
    93.5 (84.3 to 98.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 Using the FDA Snapshot Analysis

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 20 Copies/mL at Week 48 Using the FDA Snapshot Analysis
    End point description
    The percentage of participants with HIV-1 RNA < 20 copies/mL at Week 48 was also 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. Week 12 window was between Day 295 and 378 (inclusive). Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    88.9 (73.9 to 96.9)
    96.2 (80.4 to 99.9)
    91.9 (82.2 to 97.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Failure (M = F) Approach

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Failure (M = F) Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    97.2 (85.5 to 99.9)
    96.2 (80.4 to 99.9)
    96.8 (88.8 to 99.6)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = F Approach

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = F Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    91.7 (77.5 to 98.2)
    100.0 (86.8 to 100.0)
    95.2 (86.5 to 99.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = F Approach

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = F Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    36
    26
    62
    Units: percentage of participants
        number (confidence interval 95%)
    91.7 (77.5 to 98.2)
    96.2 (80.4 to 99.9)
    93.5 (84.3 to 98.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Excluded (M = E) Approach

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 Using the Missing = Excluded (M = E) Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    35
    26
    61
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (90.0 to 100.0)
    96.2 (80.4 to 99.9)
    98.4 (91.2 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = E Approach

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 Using the M = E Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    33
    26
    59
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (89.4 to 100.0)
    100.0 (86.8 to 100.0)
    100.0 (93.9 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 Using the M = E Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was also analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    33
    25
    58
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (89.4 to 100.0)
    100.0 (86.3 to 100.0)
    100.0 (93.8 to 100.0)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 12

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    End point title
    		 Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1); Week 12
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    33
    25
    58
    Units: cells/μL
        arithmetic mean (standard deviation)
    -47 ( 194.1 )
    -6 ( 116.1 )
    -30 ( 165.1 )
    No statistical analyses for this end point

    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 (Day 1); Week 24
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    33
    26
    59
    Units: cells/μL
        arithmetic mean (standard deviation)
    -40 ( 162.1 )
    28 ( 212.5 )
    -10 ( 187.4 )
    No statistical analyses for this end point

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

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    End point title
    		 Change from Baseline in CD4+ Cell Count at Week 48
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1); Week 48
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    31
    25
    56
    Units: cells/μL
        arithmetic mean (standard deviation)
    -6 ( 131.9 )
    27 ( 120.4 )
    9 ( 126.8 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 Percentage (%) at Week 12

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    End point title
    		 Change From Baseline in CD4 Percentage (%) at Week 12
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1); Week 12
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    33
    25
    58
    Units: percentage of CD4 cells
        arithmetic mean (standard deviation)
    -0.4 ( 3.37 )
    1.5 ( 3.01 )
    0.4 ( 3.33 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 % at Week 24

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    End point title
    		 Change From Baseline in CD4 % 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 (Day 1); Week 24
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    33
    26
    59
    Units: percentage of CD4 cells
        arithmetic mean (standard deviation)
    0.1 ( 3.25 )
    1.1 ( 4.30 )
    0.5 ( 3.75 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in CD4 % at Week 48

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    End point title
    		 Change From Baseline in CD4 % 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 (Day 1); Week 48
    End point values
    		 Part 1: E/C/F/TAF Part 2: E/C/F/TAF Total E/C/F/TAF
    Number of subjects analysed
    31
    25
    56
    Units: percentage of CD4 cells
        arithmetic mean (standard deviation)
    0.2 ( 3.12 )
    1.5 ( 3.64 )
    0.8 ( 3.39 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose date up to the last dose date (maximum: 48 Weeks) plus 30 days
    Adverse event reporting additional description
    The Safety Analysis Set included all participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Total E/C/F/TAF
    Reporting group description
    		 Participants switched from their current human immunodeficiency virus (HIV) treatment regimen consisting of FTC/TDF or ABC/3TC plus a third antiretroviral agent to E/C/F/TAF (150/150/200/10 mg) FDC tablet orally once daily for 48 weeks.

    Serious adverse events
    		 Total E/C/F/TAF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 64 (7.81%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Proteinuria
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total E/C/F/TAF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 64 (40.63%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    8
    Dizziness
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    4
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    7 / 64 (10.94%)
         occurrences all number
    9
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    6
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    5
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    7 / 64 (10.94%)
         occurrences all number
    11
    Nasopharyngitis
         subjects affected / exposed
    7 / 64 (10.94%)
         occurrences all number
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Aug 2016
    Amendment 1: - Addition of FPV: Fosamprenavir, SQV: Saquinavir and ETR: Etravirine in the Glossary of Abbreviations - Addition of Titles Code of Federal Regulations (CRF) referenced - Addition of the K70E RT mutation as an exclusionary mutation for Part 1 and Part 2 of 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
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