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    Clinical Trial Results:
    A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects with Chronic Genotype 3 HCV Infection and Cirrhosis

    Summary
    EudraCT number
    		 2015-002996-12
    Trial protocol
    		 DE   GB   FR  
    Global end of trial date
    02 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2017
    First version publication date
    16 Dec 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-367-1173
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02639338
    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
    Clinical Trials Mailbox, Gilead Sciences International Ltd , ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd , ClinicalTrialDisclosures@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
    02 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 HCV infection and cirrhosis.
    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
    23 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 Kingdom: 15
    Country: Number of subjects enrolled
    France: 26
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    New Zealand: 5
    Country: Number of subjects enrolled
    Canada: 34
    Country: Number of subjects enrolled
    Australia: 26
    Country: Number of subjects enrolled
    United States: 96
    Worldwide total number of subjects
    220
    EEA total number of subjects
    59
    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)
    204
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 23 December 2015. The last study visit occurred on 02 January 2017.

    Pre-assignment
    Screening details
    		 315 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SOF/VEL/VOX 8 Weeks
    Arm description
    		 SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/Velpatasvir/Voxilaprevir
    Investigational medicinal product code
    Other name
    Vosevi®, SOF/VEL/VOX
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400/100/100 mg once daily with food for 8 weeks

    Arm title
    		 SOF/VEL 12 Weeks
    Arm description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/Velpatasvir
    Investigational medicinal product code
    Other name
    Epclusa®, SOF/VEL
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400/100 mg once daily without regard to food for 12 weeks

    Number of subjects in period 1 [1]
    		SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Started
    110
    109
    Completed
    106
    105
    Not completed
    4
    4
         Withdrew Consent
    1
    2
         Death
    1
    -
         Lost to follow-up
    2
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 1 participant in SOF/VEL group who was randomized but not treated is not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOF/VEL/VOX 8 Weeks
    Reporting group description
    		 SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks

    Reporting group title
    SOF/VEL 12 Weeks
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food for 12 weeks

    Reporting group values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks Total
    Number of subjects
    		 110 109 219
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54 ± 8.5 55 ± 8.4 -
    Gender categorical
    Units: Subjects
        Female
    		 36 26 62
        Male
    		 74 83 157
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 41 52 93
        CT
    		 57 44 101
        TT
    		 12 13 25
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 40 28 68
        ≥ 800,000 IU/mL
    		 70 81 151
    Race
    Units: Subjects
        White
    		 100 97 197
        Asian
    		 8 9 17
        American Indian or Alaska Native
    		 1 1 2
        Black or African American
    		 0 1 1
        Native Hawaiian or Pacific Islander
    		 0 1 1
        Other
    		 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 9 8 17
        Not Hispanic or Latino
    		 101 101 202
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.0 ± 0.8 6.3 ± 0.63 -

    End points

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    End points reporting groups
    Reporting group title
    SOF/VEL/VOX 8 Weeks
    Reporting group description
    		 SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks

    Reporting group title
    SOF/VEL 12 Weeks
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily without regard to food 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
    1) SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. 2) Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of the 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: The statistical analysis of this primary efficacy endpoint is provided in the attachment.
    End point values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    110
    109
    Units: percentage of participants
        number (confidence interval 95%)
    96.4 (91.0 to 99.0)
    96.3 (90.9 to 99.0)
    Attachments
    		 Untitled (Filename: Primary Efficacy Endpoint Analysis.pdf)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event [2]
    End point description
    End point type
    Primary
    End point timeframe
    Up to 12 weeks
    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 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    110
    109
    Units: percentage of participants
        number (not applicable)
    0
    0.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

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    End point title
    		 Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    End point description
    1) SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. 2) Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    110
    109
    Units: percentage of participants
    number (confidence interval 95%)
        SVR4
    97.3 (92.2 to 99.4)
    97.2 (92.2 to 99.4)
        SVR24
    96.4 (91.0 to 99.0)
    96.3 (90.9 to 99.0)
    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
    1) Percentage of participants in Full Analysis Set with on-treatment data were analyzed. 2) 999 = Not Applicable (NA) (The treatment for this group was only 8 weeks.)
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 8 and 12
    End point values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    110
    109
    Units: percentage of participants
    number (confidence interval 95%)
        Week 1 (SOF/VEL/VOX: N = 110; SOF/VEL: N= 109)
    17.3 (10.7 to 25.7)
    10.1 (5.1 to 17.3)
        Week 2 (SOF/VEL/VOX: N = 110; SOF/VEL: N= 108)
    56.4 (46.6 to 65.8)
    50.9 (41.1 to 60.7)
        Week 4 (SOF/VEL/VOX: N = 110; SOF/VEL: N= 108)
    87.3 (79.6 to 92.6)
    85.2 (77.1 to 91.3)
        Week 8 (SOF/VEL/VOX: N = 110; SOF/VEL: N= 108)
    97.3 (92.2 to 99.4)
    99.1 (94.9 to 100.0)
        Week 12 (SOF/VEL/VOX: N = NA; SOF/VEL: N= 107)
    999 (999 to 999)
    100.0 (96.6 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
    1) Participants in the Full Analysis Set with available data were analyzed. 2) 999 = Not Applicable (NA) (The treatment for this group was only 8 weeks.)
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 8 and 12
    End point values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    110
    109
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 1 (SOF/VEL/VOX: N = 106; SOF/VEL: N= 105)
    -4.06 ± 0.716
    -4.09 ± 0.653
        Week 2 (SOF/VEL/VOX: N = 109; SOF/VEL: N= 107)
    -4.60 ± 0.825
    -4.73 ± 0.783
        Week 4 (SOF/VEL/VOX: N = 109; SOF/VEL: N= 108)
    -4.84 ± 0.789
    -5.00 ± 0.781
        Week 8 (SOF/VEL/VOX: N = 107; SOF/VEL: N= 108)
    -4.9 ± 0.801
    -5.09 ± 0.832
        Week 12 (SOF/VEL/VOX: N = NA; SOF/VEL: N= 107)
    999 ± 999
    -5.14 ± 0.630
    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
    1) Virologic failure was defined as either on‐treatment virologic failure or virologic relapse. On‐treatment virologic failure = either breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ on 2 consecutive measurements while on treatment), or rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment). Virologic relapse = confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on‐treatment visit. 2) Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 24
    End point values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    110
    109
    Units: percentage of participants
        number (not applicable)
    1.8
    1.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 weeks plus 30 days
    Adverse event reporting additional description
    Safety Analysis Set
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    SOF/VEL/VOX 8 Weeks
    Reporting group description
    		 SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks

    Reporting group title
    SOF/VEL 12 Weeks
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet once daily without regard to food for 12 weeks

    Serious adverse events
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 110 (1.82%)
    3 / 109 (2.75%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Pelvic fracture
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Costochondritis
         subjects affected / exposed
    1 / 110 (0.91%)
    0 / 109 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    0 / 110 (0.00%)
    1 / 109 (0.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    68 / 110 (61.82%)
    61 / 109 (55.96%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    27 / 110 (24.55%)
    32 / 109 (29.36%)
         occurrences all number
    28
    34
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    28 / 110 (25.45%)
    31 / 109 (28.44%)
         occurrences all number
    28
    31
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    23 / 110 (20.91%)
    10 / 109 (9.17%)
         occurrences all number
    23
    10
    Diarrhoea
         subjects affected / exposed
    17 / 110 (15.45%)
    5 / 109 (4.59%)
         occurrences all number
    17
    5
    Abdominal pain
         subjects affected / exposed
    9 / 110 (8.18%)
    5 / 109 (4.59%)
         occurrences all number
    9
    5
    Abdominal pain upper
         subjects affected / exposed
    2 / 110 (1.82%)
    7 / 109 (6.42%)
         occurrences all number
    2
    7
    Vomiting
         subjects affected / exposed
    7 / 110 (6.36%)
    1 / 109 (0.92%)
         occurrences all number
    7
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    6 / 110 (5.45%)
    5 / 109 (4.59%)
         occurrences all number
    6
    5
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    7 / 110 (6.36%)
    2 / 109 (1.83%)
         occurrences all number
    7
    2
    Back pain
         subjects affected / exposed
    1 / 110 (0.91%)
    6 / 109 (5.50%)
         occurrences all number
    1
    7
    Myalgia
         subjects affected / exposed
    1 / 110 (0.91%)
    6 / 109 (5.50%)
         occurrences all number
    1
    6

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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