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    Clinical Trial Results:
    An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects who Participated in a Prior Gilead-Sponsored HCV Treatment Study

    Summary
    EudraCT number
    		 2017-000179-98
    Trial protocol
    		 GB  
    Global end of trial date
    19 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Mar 2019
    First version publication date
    24 Mar 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-367-4181
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03118843
    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
    19 Mar 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Mar 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.
    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
    25 Apr 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    New Zealand: 3
    Country: Number of subjects enrolled
    Canada: 2
    Country: Number of subjects enrolled
    United States: 20
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 2
    Worldwide total number of subjects
    31
    EEA total number of subjects
    4
    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)
    25
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in North America, Europe, New Zealand, and Australia. The first participant was screened on 25 April 2017. The last study visit occurred on 19 March 2018.

    Pre-assignment
    Screening details
    		 38 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/VOX
    Arm description
    		 SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/velpatasvir/voxilaprevir
    Investigational medicinal product code
    Other name
    SOF/VEL/VOX, Vosevi®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400/100/100 mg FDC tablet administered orally once daily with food

    Number of subjects in period 1
    		SOF/VEL/VOX
    Started
    31
    Completed
    31

    Baseline characteristics

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

    Reporting group values
    		 SOF/VEL/VOX Total
    Number of subjects
    		 31 31
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60 ( 7.1 ) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 23 23
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 2
        Not Hispanic or Latino
    		 29 29
    Race
    Units: Subjects
        White
    		 25 25
        Black or African American
    		 5 5
        Not Disclosed
    		 1 1
    HCV Genotype
    Units: Subjects
        Genotype 1
    		 19 19
        Genotype 2
    		 2 2
        Genotype 3
    		 8 8
        Genotype 4
    		 1 1
        Genotype 5
    		 1 1
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 3 3
        CT
    		 21 21
        TT
    		 7 7
    Cirrhosis Status
    Units: Subjects
        Yes
    		 15 15
        No
    		 16 16
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 6 6
        ≥ 800,000 IU/mL
    		 25 25
    HCV RNA (log10 IU/mL)
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.5 ( 0.56 ) -

    End points

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

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

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    End point title
    		 Percentage of Participants With Sustained Virologic Response (SVR) 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) at 12 weeks after stopping study treatment. Full Analysis Set included all enrolled participants who took 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/VOX
    Number of subjects analysed
    31
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (88.8 to 100.0)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [2]
    End point description
    Participants in the Safety Analysis Set were analyzed.
    End point type
    Primary
    End point timeframe
    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/VOX
    Number of subjects analysed
    31
    Units: percentage of participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)

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    End point title
    		 Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
    End point description
    SVR4 was defined as HCV RNA < LLOQ at 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/VOX
    Number of subjects analysed
    31
    Units: percentage of participants
        number (confidence interval 95%)
    100.0 (88.8 to 100.0)
    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, 8, and 12
    End point values
    		 SOF/VEL/VOX
    Number of subjects analysed
    31
    Units: percentage of participants
    number (confidence interval 95%)
        Week 2
    51.6 (33.1 to 69.8)
        Week 4
    96.8 (83.3 to 99.9)
        Week 8
    100.0 (88.8 to 100.0)
        Week 12
    100.0 (88.8 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
    Virologic failure was defined as: 1) On-treatment virologic failure: • Breakthrough (confirmed HCV RNA ≥ LLOQ after 2 consecutive HCV RNA < LLOQ), 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) 2) Virologic relapse: Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 12
    End point values
    		 SOF/VEL/VOX
    Number of subjects analysed
    31
    Units: percentage of participants
        number (not applicable)
    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, 8, and 12
    End point values
    		 SOF/VEL/VOX
    Number of subjects analysed
    31
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Change at Week 2 (N = 29)
    -5.16 ( 0.560 )
        Change at Week 4 (N = 30)
    -5.34 ( 0.571 )
        Change at Week 8 (N = 31)
    -5.34 ( 0.563 )
        Change at Week 12 (N = 31)
    -5.34 ( 0.563 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
    Adverse event reporting additional description
    Safety Analysis Set included all participants who took at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    SOF/VEL/VOX
    Reporting group description
    		 SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks

    Serious adverse events
    		 SOF/VEL/VOX
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 31 (3.23%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 31 (3.23%)
         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/VOX
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 31 (54.84%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences all number
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 31 (16.13%)
         occurrences all number
    5
    Pain
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 31 (16.13%)
         occurrences all number
    5
    Abdominal distension
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Dyspepsia
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    3
    Pneumonia
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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