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    Clinical Trial Results:
    A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease

    Summary
    EudraCT number
    		 2016-003625-42
    Trial protocol
    		 GB   ES  
    Global end of trial date
    07 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Nov 2019
    First version publication date
    27 Nov 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-342-4062
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03036852
    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
    07 Nov 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Mar 2017
    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
    Spain: 6
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    Canada: 25
    Country: Number of subjects enrolled
    Israel: 6
    Country: Number of subjects enrolled
    New Zealand: 4
    Country: Number of subjects enrolled
    Australia: 2
    Worldwide total number of subjects
    59
    EEA total number of subjects
    22
    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)
    39
    From 65 to 84 years
    18
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Canada, the United Kingdom, Spain, Israel, New Zealand, and Australia. The first participant was screened on 22 March 2017. The last study visit occurred on 07 November 2018.

    Pre-assignment
    Screening details
    		 78 participants were screened.

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

    Arms
    Arm title
    		 SOF/VEL
    Arm description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/Velpatasvir
    Investigational medicinal product code
    Other name
    SOF/VEL; Epclusa®; GS-7977/GS-5816
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400/100 mg administered orally once daily

    Number of subjects in period 1
    		SOF/VEL
    Started
    59
    Completed
    53
    Not completed
    6
         Adverse event, non-fatal
    1
         Death
    2
         Lost to follow-up
    1
         Lack of efficacy
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOF/VEL
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks

    Reporting group values
    		 SOF/VEL Total
    Number of subjects
    		 59 59
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60 ( 12.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 35 35
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 3
        Not Hispanic or Latino
    		 56 56
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 2 2
        Asian
    		 18 18
        Native Hawaiian or Other Pacific Islander
    		 2 2
        Black or African American
    		 6 6
        White
    		 31 31
    IL28b Status
    Units: Subjects
        CC
    		 23 23
        CT
    		 30 30
        TT
    		 6 6
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 26 26
        ≥ 800,000 IU/mL
    		 33 33
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 5.8 ( 1.02 ) -
    Subject analysis sets

    Subject analysis set title
    SOF/VEL (GT-1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection

    Subject analysis set title
    SOF/VEL (GT-2)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection

    Subject analysis set title
    SOF/VEL (GT-3)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection

    Subject analysis set title
    SOF/VEL (GT-4)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection

    Subject analysis set title
    SOF/VEL (GT-6)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection

    Subject analysis set title
    SOF/VEL (Indeterminate)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection

    Subject analysis sets values
    		 SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
    Number of subjects
    25
    7
    16
    4
    2
    5
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63 ( 11.9 )
    67 ( 13.5 )
    55 ( 8.4 )
    58 ( 15.5 )
    69 ( 3.5 )
    52 ( 13.0 )
    Gender categorical
    Units: Subjects
        Female
    10
    4
    5
    1
    1
    3
        Male
    15
    3
    11
    3
    1
    2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    2
    0
    0
    0
    0
    1
        Not Hispanic or Latino
    23
    7
    16
    4
    2
    4
    Race
    Units: Subjects
        American Indian or Alaska Native
    1
    0
    1
    0
    0
    0
        Asian
    6
    1
    7
    1
    2
    1
        Native Hawaiian or Other Pacific Islander
    1
    0
    1
    0
    0
    0
        Black or African American
    1
    2
    0
    2
    0
    1
        White
    16
    4
    7
    1
    0
    3
    IL28b Status
    Units: Subjects
        CC
    9
    4
    6
    0
    1
    3
        CT
    14
    1
    8
    4
    1
    2
        TT
    2
    2
    2
    0
    0
    0
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    12
    5
    4
    2
    0
    3
        ≥ 800,000 IU/mL
    13
    2
    12
    2
    2
    2
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    6.0 ( 0.70 )
    5.2 ( 1.04 )
    6.4 ( 0.55 )
    5.6 ( 1.55 )
    6.4 ( 0.27 )
    4.4 ( 1.69 )

    End points

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    End points reporting groups
    Reporting group title
    SOF/VEL
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks

    Subject analysis set title
    SOF/VEL (GT-1)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection

    Subject analysis set title
    SOF/VEL (GT-2)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection

    Subject analysis set title
    SOF/VEL (GT-3)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection

    Subject analysis set title
    SOF/VEL (GT-4)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection

    Subject analysis set title
    SOF/VEL (GT-6)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection

    Subject analysis set title
    SOF/VEL (Indeterminate)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection

    Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [1]
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping study treatment.The Full Analysis Set included participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Posttreatment 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 statistical comparison was planned or performed.
    End point values
    		 SOF/VEL SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
    Number of subjects analysed
    59
    25
    7
    16
    4
    2
    5
    Units: Percentage of participants
        number (confidence interval 95%)
    94.9 (85.9 to 98.9)
    92.0 (74.0 to 99.0)
    100.0 (59.0 to 100.0)
    93.8 (69.8 to 99.8)
    100.0 (39.8 to 100.0)
    100.0 (15.8 to 100.0)
    100.0 (47.8 to 100.0)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event [2]
    End point description
    The Safety Analysis Set included all participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    First dose date up to Week 12
    Notes
    [2] - 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
    		 SOF/VEL
    Number of subjects analysed
    59
    Units: Percentage of participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
    End point description
    SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 4
    End point values
    		 SOF/VEL SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
    Number of subjects analysed
    59
    25
    7
    16
    4
    2
    5
    Units: Percentage of participants
        number (confidence interval 95%)
    96.6 (88.3 to 99.6)
    96.0 (79.6 to 99.9)
    100.0 (59.0 to 100.0)
    93.8 (69.8 to 99.8)
    100.0 (39.8 to 100.0)
    100.0 (15.8 to 100.0)
    100.0 (47.8 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
    End point description
    SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Posttreatment Week 24
    End point values
    		 SOF/VEL SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
    Number of subjects analysed
    59
    25
    7
    16
    4
    2
    5
    Units: Percentage of participants
        number (confidence interval 95%)
    94.9 (85.9 to 98.9)
    92.0 (74.0 to 99.0)
    100.0 (59.0 to 100.0)
    93.8 (69.8 to 99.8)
    100.0 (39.8 to 100.0)
    100.0 (15.8 to 100.0)
    100.0 (47.8 to 100.0)
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA

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    End point title
    		 Change From Baseline in HCV RNA
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 2, 4, 6, 8, and 12
    End point values
    		 SOF/VEL SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
    Number of subjects analysed
    59
    25
    7
    16
    4
    2
    5
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Change at Week 2 (N = 59, 25, 6, 13, 4, 2, 5)
    -4.54 ( 1.017 )
    -4.69 ( 0.797 )
    -3.78 ( 0.840 )
    -5.07 ( 0.493 )
    -4.23 ( 1.333 )
    -5.29 ( 0.269 )
    -3.24 ( 1.668 )
        Change at Week 4 (N = 59, 25, 7, 16, 4, 2, 5)
    -4.69 ( 1.020 )
    -4.81 ( 0.704 )
    -4.05 ( 1.041 )
    -5.20 ( 0.551 )
    -4.48 ( 1.547 )
    -5.29 ( 0.269 )
    -3.26 ( 1.692 )
        Change at Week 6 (N = 59, 25, 7, 16, 4, 2, 5)
    -4.69 ( 1.020 )
    -4.81 ( 0.704 )
    -4.05 ( 1.041 )
    -5.20 ( 0.551 )
    -4.48 ( 1.547 )
    -5.29 ( 0.269 )
    -3.26 ( 1.692 )
        Change at Week 8 (N = 59, 25, 7, 16, 4, 2, 5)
    -4.69 ( 1.020 )
    -4.81 ( 0.704 )
    -4.05 ( 1.041 )
    -5.20 ( 0.551 )
    -4.48 ( 1.547 )
    -5.29 ( 0.269 )
    -3.26 ( 1.692 )
        Change at Week 12 (N = 59, 25, 7, 16, 4, 2, 5)
    -4.69 ( 1.020 )
    -4.81 ( 0.704 )
    -4.05 ( 1.041 )
    -5.20 ( 0.551 )
    -4.48 ( 1.547 )
    -5.29 ( 0.269 )
    -3.26 ( 1.692 )
    No statistical analyses for this end point

    Secondary: Percentage of participants with HCV RNA < LLOQ on treatment

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    End point title
    		 Percentage of participants with HCV RNA < LLOQ on treatment
    End point description
    Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 6, 8, and 12
    End point values
    		 SOF/VEL SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
    Number of subjects analysed
    59
    25
    7
    16
    4
    2
    5
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 2
    67.8 (54.4 to 79.4)
    76.0 (54.9 to 90.6)
    85.7 (42.1 to 99.6)
    43.8 (19.8 to 70.1)
    50.0 (6.8 to 93.2)
    100.0 (15.8 to 100.0)
    80.0 (28.4 to 99.5)
        Week 4
    100.0 (93.9 to 100.0)
    100.0 (86.3 to 100.0)
    100.0 (59.0 to 100.0)
    100.0 (79.4 to 100.0)
    100.0 (39.8 to 100.0)
    100.0 (15.8 to 100.0)
    100.0 (47.8 to 100.0)
        Week 6
    100.0 (93.9 to 100.0)
    100.0 (86.3 to 100.0)
    100.0 (59.0 to 100.0)
    100.0 (79.4 to 100.0)
    100.0 (39.8 to 100.0)
    100.0 (15.8 to 100.0)
    100.0 (47.8 to 100.0)
        Week 8
    100.0 (93.9 to 100.0)
    100.0 (86.3 to 100.0)
    100.0 (59.0 to 100.0)
    100.0 (79.4 to 100.0)
    100.0 (39.8 to 100.0)
    100.0 (15.8 to 100.0)
    100.0 (47.8 to 100.0)
        Week 12
    100.0 (93.9 to 100.0)
    100.0 (86.3 to 100.0)
    100.0 (59.0 to 100.0)
    100.0 (79.4 to 100.0)
    100.0 (39.8 to 100.0)
    100.0 (15.8 to 100.0)
    100.0 (47.8 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virologic Failure

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    End point title
    		 Percentage of Participants With Virologic Failure
    End point description
    Participants in the Full Analysis Set were analyzed. Virologic failure was defined as: - On-treatment virologic failure: -- Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or -- Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or -- Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) - Virologic relapse: -- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit
    End point type
    Secondary
    End point timeframe
    Baseline to Posttreatment Week 24
    End point values
    		 SOF/VEL SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
    Number of subjects analysed
    59
    25
    7
    16
    4
    2
    5
    Units: Percentage of participants
        number (not applicable)
    3.4
    4.0
    0
    6.3
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment

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    End point title
    		 Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment
    End point description
    Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL. Participants in the Resistance Analysis Population Set included all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. All data are reported at a 15% assay cutoff.
    End point type
    Secondary
    End point timeframe
    First dose date up to Posttreatment Week 24
    End point values
    		 SOF/VEL
    Number of subjects analysed
    58
    Units: Percentage of participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK) Parameter: AUCtau of SOF

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    End point title
    		 Pharmacokinetic (PK) Parameter: AUCtau of SOF
    End point description
    AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. Participants in the PK Analysis Set (all participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma) with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of SOF.
    End point type
    Secondary
    End point timeframe
    Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
    End point values
    		 SOF/VEL
    Number of subjects analysed
    21
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    2381.9 ( 567.63 )
    No statistical analyses for this end point

    Secondary: PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)

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    End point title
    		 PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
    End point description
    AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of GS-331007 .
    End point type
    Secondary
    End point timeframe
    Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
    End point values
    		 SOF/VEL
    Number of subjects analysed
    59
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    230989.2 ( 81453.30 )
    No statistical analyses for this end point

    Secondary: PK Parameter: AUCtau of VEL

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    End point title
    		 PK Parameter: AUCtau of VEL
    End point description
    AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval. Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of VEL.
    End point type
    Secondary
    End point timeframe
    Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
    End point values
    		 SOF/VEL
    Number of subjects analysed
    59
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    4279.4 ( 2198.77 )
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax of SOF

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    End point title
    		 PK Parameter: Cmax of SOF
    End point description
    Cmax is defined as the population PK derived maximum concentration of the drug. Participants in the PK Analysis set with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of SOF.
    End point type
    Secondary
    End point timeframe
    Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
    End point values
    		 SOF/VEL
    Number of subjects analysed
    21
    Units: ng/mL
        arithmetic mean (standard deviation)
    1041.0 ( 176.96 )
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax of GS-331007 (Metabolite of SOF)

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    End point title
    		 PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
    End point description
    Cmax is defined as the population PK derived maximum concentration of the drug. Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of GS-331007.
    End point type
    Secondary
    End point timeframe
    Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
    End point values
    		 SOF/VEL
    Number of subjects analysed
    59
    Units: ng/mL
        arithmetic mean (standard deviation)
    9776.2 ( 3433.16 )
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax of VEL

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    End point title
    		 PK Parameter: Cmax of VEL
    End point description
    Cmax is defined as the population PK derived maximum concentration of the drug. Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of VEL.
    End point type
    Secondary
    End point timeframe
    Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
    End point values
    		 SOF/VEL
    Number of subjects analysed
    59
    Units: ng/mL
        arithmetic mean (standard deviation)
    226.9 ( 92.80 )
    No statistical analyses for this end point

    Secondary: PK Parameter: Ctau of VEL

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    End point title
    		 PK Parameter: Ctau of VEL
    End point description
    Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose. Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Ctau of VEL.
    End point type
    Secondary
    End point timeframe
    Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
    End point values
    		 SOF/VEL
    Number of subjects analysed
    59
    Units: ng/mL
        arithmetic mean (standard deviation)
    137.2 ( 95.91 )
    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 Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
    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
    21.1
    Reporting groups
    Reporting group title
    SOF/VEL
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks

    Serious adverse events
    		 SOF/VEL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 59 (18.64%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neurilemmoma benign
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Post procedural swelling
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pubis fracture
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Depression
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 59 (1.69%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 59 (1.69%)
         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
    		 SOF/VEL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    33 / 59 (55.93%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 59 (16.95%)
         occurrences all number
    11
    Dizziness
         subjects affected / exposed
    5 / 59 (8.47%)
         occurrences all number
    5
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 59 (13.56%)
         occurrences all number
    10
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 59 (13.56%)
         occurrences all number
    9
    Vomiting
         subjects affected / exposed
    8 / 59 (13.56%)
         occurrences all number
    10
    Constipation
         subjects affected / exposed
    4 / 59 (6.78%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    3 / 59 (5.08%)
         occurrences all number
    3
    Dyspepsia
         subjects affected / exposed
    3 / 59 (5.08%)
         occurrences all number
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 59 (5.08%)
         occurrences all number
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 59 (8.47%)
         occurrences all number
    5
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 59 (10.17%)
         occurrences all number
    6
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    4 / 59 (6.78%)
         occurrences all number
    4
    Muscle spasms
         subjects affected / exposed
    3 / 59 (5.08%)
         occurrences all number
    3
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 59 (5.08%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Nov 2016
    • The hemodialysis PK substudy design was updated to remove dialysate collection. • An inclusion criterion that the most recent HCV treatment must have been completed at least 8 weeks prior to screening was added.
    30 Jan 2017
    • Infection with hepatitis B virus (HBV) was removed from the exclusion criteria • Hepatitis B core antibody (HBcAb) and hepatitis B surface antigen (HBsAg) testing was added at screening. In addition, for subjects who were HBcAb+ at screening, HBV DNA testing was performed at baseline/Day 1, every 4 weeks on-treatment and at posttreatment Weeks 4, 12, and 24. • During the conduct of the study, the number of subjects the Data Monitoring Committee (DMC) would evaluate was updated from the first 25 subjects to the first 12 subjects having completed 12 weeks of treatment or early termination, and every 3 months thereafter. The subsequent safety reviews alternated between a review by the DMC chair of all serious adverse events (SAEs) and deaths, and a review of safety data by the DMC meeting as specified by the DMC charter.
    02 Mar 2017
    Nonclinical toxicology information was added to communicate to investigators the potential for hematologic toxicity (decreased red blood cell [RBC] counts) associated with higher GS-331007 exposure.

    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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