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    Clinical Trial Results:
    A Phase 3b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis

    Summary
    EudraCT number
    2015-002713-30
    Trial protocol
    GB   AT   FR   DE  
    Global end of trial date
    15 Oct 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Oct 2020
    First version publication date
    29 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-292-1825
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02600819
    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
    15 Oct 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Sep 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Oct 2019
    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 and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV-1) infected adults with end-stage renal disease (ESRD) on chronic hemodialysis (HD).
    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
    14 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
    United States: 46
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Germany: 1
    Worldwide total number of subjects
    55
    EEA total number of subjects
    9
    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)
    55
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were enrolled at study sites in Europe and the United States. The first participant was screened on 14 December 2015. The last study visit occurred on 15 October 2019.

    Pre-assignment
    Screening details
    75 participants were screened.

    Period 1
    Period 1 title
    GEN Phase
    Is this the baseline period?
    Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    E/C/F/TAF (GEN Phase)
    Arm description
    Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 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
    E/C/F/TAF (GEN Phase)
    Started
    55
    Completed
    39
    Not completed
    16
         Death
    2
         Withdrew Consent
    5
         Non-Compliance with Study Drug
    1
         Investigator`s Discretion
    4
         Adverse Event
    2
         Lost to follow-up
    2
    Period 2
    Period 2 title
    BVY OL Extension Phase
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
    Arm description
    At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    B/F/TAF FDC
    Investigational medicinal product code
    Other name
    Biktarvy®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50/200/25 mg administered once daily

    Number of subjects in period 2 [1]
    E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
    Started
    10
    Completed
    10
    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: 29 participants completed the GEN Phase, but did not enter in the BVY OL Extension Phase.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    E/C/F/TAF (GEN Phase)
    Reporting group description
    Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.

    Reporting group values
    E/C/F/TAF (GEN Phase) Total
    Number of subjects
    55 55
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    48 ± 11.0 -
    Gender categorical
    Units: Subjects
        Female
    13 13
        Male
    42 42
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    8 8
        Not Hispanic or Latino
    47 47
    Race
    Units: Subjects
        American Indian or Alaska Native
    0 0
        Asian
    0 0
        Black
    45 45
        Native Hawaiian or Pacific Islander
    0 0
        White
    10 10
        Other
    0 0
    HIV-1 RNA Category
    Units: Subjects
        < 50 copies/mL
    54 54
        ≥ 50 copies/mL
    1 1
    CD4+ Cell Count Categories
    Units: Subjects
        < 50 cells/µL
    0 0
        >= 50 to < 200 cells/µL
    0 0
        >= 200 to < 350 cells/µL
    12 12
        >= 350 to < 500 cells/µL
    14 14
        >= 500 cells/µL
    29 29
    Cluster Determinant 4+ (CD4+) Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    545 ± 239.2 -
    CD4 Percentage
    Units: percentage of CD4 cells
        arithmetic mean (standard deviation)
    31.5 ± 9.41 -

    End points

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    End points reporting groups
    Reporting group title
    E/C/F/TAF (GEN Phase)
    Reporting group description
    Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.
    Reporting group title
    E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
    Reporting group description
    At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks.

    Primary: GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48

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    End point title
    GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 48 [1]
    End point description
    Treatment-emergent Adverse Events (TEAE) were defined as AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug or all AEs for participants still on E/C/F/TAF. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities. Adverse events were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). The GEN Safety Analysis Set included participants who were enrolled and received at least 1 dose of GEN (E/C/F/TAF FDC).
    End point type
    Primary
    End point timeframe
    First Dose Date Up to Week 48
    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 statistical comparison was planned or performed.
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    55
    Units: percentage of participants
        number (not applicable)
    32.7
    No statistical analyses for this end point

    Secondary: GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 96

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    End point title
    GEN Phase: Percentage of Participants Experiencing Treatment-Emergent Grade 3 or Higher Adverse Events Up to Week 96
    End point description
    Treatment-emergent Adverse Events (TEAE) were defined as events that met 1 or both of the following criteria as any AEs with onset dates on or after the study drug start date and no later than 30 days after the permanent discontinuation of the E/C/F/TAF (GEN Phase) study drug for participants who did not participate in the BVY OL extension phase or the day prior to the date of the first B/F/TAF study drug dose for participants who participated in the BVY OL extension phase. It also includes the AEs that led to premature discontinuation of E/C/F/TAF study drug. Clinical events and clinically significant laboratory abnormalities were graded according to the GSI Grading Scale for Severity of Adverse Events and Laboratory Abnormalities. Adverse events were graded as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), or Grade 4 (life threatening). Participants in the GEN Safety Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    First Dose Date Up to Week 96
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    55
    Units: percentage of participants
        number (not applicable)
    43.6
    No statistical analyses for this end point

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

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    End point title
    GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the FDA 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. The GEN Full Analysis Set included participants who were enrolled and received at least 1 dose of GEN (E/C/F/TAF FDC).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    55
    Units: percentage of participants
        number (confidence interval 95%)
    87.3 (75.5 to 94.7)
    No statistical analyses for this end point

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

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    End point title
    GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the FDA 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. Participants in the GEN Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    55
    Units: percentage of participants
        number (confidence interval 95%)
    81.8 (69.1 to 90.9)
    No statistical analyses for this end point

    Secondary: GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA Snapshot Algorithm

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    End point title
    GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the FDA Snapshot Algorithm
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Participants in the GEN Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    55
    Units: percentage of participants
        number (confidence interval 95%)
    54.5 (40.6 to 68.0)
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV)

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    End point title
    Pharmacokinetic (PK) Parameter: AUCtau of Elvitegravir (EVG), Cobicistat (COBI), Emtricitabine (FTC), and Tenofovir (TFV)
    End point description
    AUCtau is defined as area under the concentration versus time curve over the dosing interval (i.e., concentration of drug over time). Participants in the PK Substudy Analysis Set (participants who were enrolled into the study, participated in the intensive PK substudy, received at least 1 dose of E/C/F/TAF FDC, and had at least 1 nonmissing plasma PK concentration value for any analyte of interest) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    11
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        EVG (N=10)
    14284.8 ± 7790.26
        COBI
    10179.5 ± 6009.28
        FTC
    62929.9 ± 30199.63
        TFV (N=10)
    8715.0 ± 3432.16
    No statistical analyses for this end point

    Secondary: PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV

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    End point title
    PK Parameter: AUClast of EVG, COBI, FTC, Tenofovir Alafenamide (TAF), and TFV
    End point description
    AUClast is defined as the area under the concentration versus time curve from time zero to the last observable concentration. Participants in the PK Substudy Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    12
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        EVG
    12857.6 ± 7894.09
        COBI
    9558.7 ± 5963.16
        FTC
    59057.4 ± 31485.96
        TAF
    231.9 ± 123.46
        TFV
    7664.2 ± 3958.36
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV

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    End point title
    PK Parameter: Cmax of EVG, COBI, FTC, TAF, and TFV
    End point description
    Cmax is defined as the maximum concentration of drug. Participants in the PK Substudy Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    12
    Units: ng/mL
    arithmetic mean (standard deviation)
        EVG
    1258.5 ± 689.57
        COBI
    1370.4 ± 920.15
        FTC
    4875.0 ± 1981.03
        TAF
    246.3 ± 185.69
        TFV
    442.8 ± 181.03
    No statistical analyses for this end point

    Secondary: PK Parameter: Ctau of EVG, COBI, FTC, and TFV

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    End point title
    PK Parameter: Ctau of EVG, COBI, FTC, and TFV
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Ctau has been presented in lieu of Cmin (specified in the protocol) to align with other Gilead studies. This change has no impact on the PK analysis as Ctau and Cmin are equivalent for all analytes. Participants in the PK Substudy Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    0.5, 1, 2, 3, 4, 6, 8, and 24 hours postdose at or between Week 2 or Week 4
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    10
    Units: ng/mL
    arithmetic mean (standard deviation)
        EVG
    174.4 ± 104.36
        COBI
    28.9 ± 34.06
        FTC
    1277.3 ± 756.60
        TFV
    264.8 ± 193.98
    No statistical analyses for this end point

    Secondary: GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Failure (M = F) Approach

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    End point title
    GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Failure (M = F) Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 were analyzed using the M = F approach. In this approach, all missing data was treated as HIV-1 RNA ≥ 50 copies/mL. Participants in the GEN Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    55
    Units: percentage of participants
        number (confidence interval 95%)
    61.8 (47.7 to 74.6)
    No statistical analyses for this end point

    Secondary: GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Excluded (M = E) Approach

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    End point title
    GEN Phase: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 Using the Missing = Excluded (M = E) Approach
    End point description
    The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 were analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. Participants in the GEN Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    34
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (89.7 to 100.0)
    No statistical analyses for this end point

    Secondary: BVY OL Extension Phase: 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
    BVY OL Extension Phase: 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 were analyzed using the M = E approach. In this approach, all missing data was excluded in the computation of the proportions. The BVY Full Analysis Set included all participants who were enrolled in the study and received at least 1 dose of BVY (B/F/TAF FDC).
    End point type
    Secondary
    End point timeframe
    Week 48 of the BVY OL Extension Phase
    End point values
    E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
    Number of subjects analysed
    10
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (69.2 to 100.0)
    No statistical analyses for this end point

    Secondary: GEN Phase: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 96

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    End point title
    GEN Phase: Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 96
    End point description
    Participants in the GEN Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 96
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    28
    Units: cells/µL
        arithmetic mean (standard deviation)
    -35 ± 218.3
    No statistical analyses for this end point

    Secondary: BVY OL Extension Phase: Change From Baseline in CD4+ Cell Count at Week 48

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    End point title
    BVY OL Extension Phase: Change From Baseline in CD4+ Cell Count at Week 48
    End point description
    Participants in the BVY Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48 of the BVY OL Extension Phase
    End point values
    E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
    Number of subjects analysed
    10
    Units: cells/µL
    arithmetic mean (standard deviation)
        Baseline
    581 ± 146.8
        Change from Baseline at Week 48 (N=9)
    -104 ± 120.8
    No statistical analyses for this end point

    Secondary: GEN Phase: Change From Baseline in CD4 Percentage at Week 96

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    End point title
    GEN Phase: Change From Baseline in CD4 Percentage at Week 96
    End point description
    Participants in the GEN Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 96
    End point values
    E/C/F/TAF (GEN Phase)
    Number of subjects analysed
    28
    Units: percentage of CD4 cells
        arithmetic mean (standard deviation)
    2.8 ± 6.37
    No statistical analyses for this end point

    Secondary: BVY OL Extension Phase: Change From Baseline in CD4 Percentage at Week 48

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    End point title
    BVY OL Extension Phase: Change From Baseline in CD4 Percentage at Week 48
    End point description
    Participants in the BVY Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 48 Week 48 of the BVY OL Extension Phase
    End point values
    E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
    Number of subjects analysed
    10
    Units: percentage of CD4 cells
    arithmetic mean (standard deviation)
        Baseline
    31.9 ± 7.37
        Change from Baseline at Week 48 (N=9)
    1.7 ± 4.39
    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: 114 Weeks (GEN Phase), 52 Weeks (BVY OL Extension Phase)] plus 30 days
    Adverse event reporting additional description
    The GEN Safety Analysis Set included all participants who received at least 1 dose of GEN. The BVY Safety Analysis Set included all participants who received at least 1 dose of BVY.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    E/C/F/TAF (GEN Phase)
    Reporting group description
    Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) (Genvoya®, GEN) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 96 weeks. At Week 96, participants in the United States (US) who wished to participate in the open-label (OL) rollover extension either discontinued E/C/F/TAF FDC or continued to take E/C/F/TAF FDC for up to 114 weeks.

    Reporting group title
    E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
    Reporting group description
    At Week 96 or the end of E/C/F/TAF visit (whichever occurred last), participants were given the option to receive open-label (OL) bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (Biktarvy®, BVY) (50/200/25 mg) FDC tablet once daily without regard to food for up to 52 weeks.

    Serious adverse events
    E/C/F/TAF (GEN Phase) E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 55 (65.45%)
    3 / 10 (30.00%)
         number of deaths (all causes)
    3
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic microangiopathy
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian vein stenosis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Renal transplant
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula site haemorrhage
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular access site haemorrhage
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Productive cough
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal hernia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal ulcer haemorrhage
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (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 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (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
    End stage renal disease
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    2 / 55 (3.64%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penile ulceration
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    6 / 55 (10.91%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    4 / 55 (7.27%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (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
    Pneumonia
         subjects affected / exposed
    8 / 55 (14.55%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    4 / 55 (7.27%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula site infection
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis staphylococcal
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 55 (1.82%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    E/C/F/TAF (GEN Phase) E/C/F/TAF to B/F/TAF (BVY OL Extension Phase)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 55 (74.55%)
    10 / 10 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 55 (3.64%)
    2 / 10 (20.00%)
         occurrences all number
    2
    3
    Hypotension
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Superior vena cava stenosis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    6 / 55 (10.91%)
    0 / 10 (0.00%)
         occurrences all number
    6
    0
    Chest pain
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Peripheral swelling
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Malaise
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Depression
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Insomnia
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Acquired phimosis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Contusion
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Face injury
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Hand fracture
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Procedural haemorrhage
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Investigations
    Electrocardiogram QT prolonged
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 55 (16.36%)
    1 / 10 (10.00%)
         occurrences all number
    12
    2
    Dyspnoea
         subjects affected / exposed
    4 / 55 (7.27%)
    1 / 10 (10.00%)
         occurrences all number
    8
    1
    Nasal congestion
         subjects affected / exposed
    3 / 55 (5.45%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 55 (7.27%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 55 (7.27%)
    1 / 10 (10.00%)
         occurrences all number
    4
    1
    Eye disorders
    Cataract
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Vision blurred
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Diplopia
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Eye pruritus
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Scleral hyperaemia
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    13 / 55 (23.64%)
    1 / 10 (10.00%)
         occurrences all number
    14
    1
    Diarrhoea
         subjects affected / exposed
    5 / 55 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    6
    0
    Constipation
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 10 (10.00%)
         occurrences all number
    3
    1
    Gastritis
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Vomiting
         subjects affected / exposed
    3 / 55 (5.45%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Abdominal pain lower
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Oesophagitis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Hidradenitis
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Neurodermatitis
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Skin ulcer
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Product issues
    Thrombosis in device
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    6 / 55 (10.91%)
    0 / 10 (0.00%)
         occurrences all number
    6
    0
    Arthralgia
         subjects affected / exposed
    5 / 55 (9.09%)
    0 / 10 (0.00%)
         occurrences all number
    5
    0
    Back pain
         subjects affected / exposed
    4 / 55 (7.27%)
    1 / 10 (10.00%)
         occurrences all number
    4
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Myalgia
         subjects affected / exposed
    2 / 55 (3.64%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    8 / 55 (14.55%)
    1 / 10 (10.00%)
         occurrences all number
    11
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 55 (7.27%)
    0 / 10 (0.00%)
         occurrences all number
    4
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 55 (1.82%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Rhinovirus infection
         subjects affected / exposed
    0 / 55 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Oct 2015
    Amendment 1: • Excluded participants with hepatitis B infection from the study • Removed toxicity management text related to the management of hepatitis B flare • Updated the timing of first administration of study drug to occur on Day 1 • Updated the rationale for dose selection with the inclusion of new modeling data • Updated the intensive PK substudy visit schedule such that blood sampling was to occur at or between the Week 2 or 4 study visits • Clarified the procedure for predose whole blood sample collection and processing • Added the collection of a long-term plasma storage samples from participants who provided consent
    28 Nov 2016
    Amendment 2: • Extended the study to Week 96 • Revised study objectives and endpoints to reflect the extension of data collection to Week 96 • Revised study procedures in accordance with extension of the study to Week 96 • Clarified the timing of the blood draw for the chemistry panel in relation to hemodialysis

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references

    http://www.ncbi.nlm.nih.gov/pubmed/30555051
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