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    Clinical Trial Results:
    An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects with Chronic HCV Infection

    Summary
    EudraCT number
    		 2014-003898-42
    Trial protocol
    		 GB   DE   BE   IT  
    Global end of trial date
    15 Jun 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 May 2017
    First version publication date
    18 May 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-342-1446
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02346721
    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 Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial 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
    15 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2016
    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 the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.
    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 Feb 2015
    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
    Canada: 6
    Country: Number of subjects enrolled
    China: 1
    Country: Number of subjects enrolled
    Hong Kong: 3
    Country: Number of subjects enrolled
    Puerto Rico: 2
    Country: Number of subjects enrolled
    United States: 42
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    France: 31
    Country: Number of subjects enrolled
    United Kingdom: 13
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Italy: 2
    Worldwide total number of subjects
    111
    EEA total number of subjects
    57
    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)
    100
    From 65 to 84 years
    11
    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 February 2015. The last study visit occurred on 15 June 2016.

    Pre-assignment
    Screening details
    		 116 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 12 Weeks
    Arm description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    SOF/VEL
    Investigational medicinal product code
    Other name
    GS-7977/GS-5816, Epclusa®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400/100 mg administered once daily

    Number of subjects in period 1
    		SOF/VEL 12 Weeks
    Started
    111
    Completed
    107
    Not completed
    4
         Withdrew Consent
    3
         Lack of Efficacy
    1

    Baseline characteristics

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

    Reporting group values
    		 SOF/VEL 12 Weeks Total
    Number of subjects
    		 111 111
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54 ( 10.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 46 46
        Male
    		 65 65
    Race
    Units: Subjects
        Black or African American
    		 12 12
        White
    		 85 85
        Asian
    		 11 11
        Native Hawaiian or Pacific Islander
    		 1 1
        Other
    		 2 2
    Ethinicity
    Units: Subjects
        Hispanic or Latino
    		 5 5
        Not Hispanic or Latino
    		 106 106
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 36 36
        CT
    		 50 50
        TT
    		 25 25
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 30 30
        ≥ 800,000 IU/mL
    		 81 81
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.3 ( 0.55 ) -

    End points

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

    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) 12 weeks following the last dose of study drug. Full Analysis Set (FAS) 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 analysis was planned or performed.
    End point values
    		 SOF/VEL 12 Weeks
    Number of subjects analysed
    111
    Units: percentage of participants
        number (confidence interval 95%)
    97.3 (92.3 to 99.4)
    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
    Safety Analysis Set included participants who took at least 1 dose of study drug.
    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 analysis was planned or performed.
    End point values
    		 SOF/VEL 12 Weeks
    Number of subjects analysed
    111
    Units: percentage of participants
        number (not applicable)
    0.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    End point description
    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 SOF/VEL 12 Weeks
    Number of subjects analysed
    111
    Units: percentage of participants
    number (confidence interval 95%)
        SVR4
    98.2 (93.6 to 99.8)
        SVR24
    97.3 (92.3 to 99.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ While on Treatment

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ While on Treatment
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 SOF/VEL 12 Weeks
    Number of subjects analysed
    111
    Units: percentage of participants
    number (confidence interval 95%)
        Week 1
    18 (11.4 to 26.4)
        Week 2
    55 (45.2 to 64.4)
        Week 4
    94.6 (88.6 to 98)
        Week 6
    99.1 (95.1 to 100)
        Week 8
    100 (96.7 to 100)
        Week 10
    100 (96.7 to 100)
        Week 12 (N = 110)
    100 (96.7 to 100)
    No statistical analyses for this end point

    Secondary: HCV RNA Change From Baseline

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    End point title
    		 HCV RNA Change From Baseline
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 SOF/VEL 12 Weeks
    Number of subjects analysed
    111
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Change at Week 1 (N= 110)
    -4.23 ( 0.592 )
        Change at Week 2
    -4.79 ( 0.627 )
        Change at Week 4
    -5.1 ( 0.546 )
        Change at Week 6
    -5.11 ( 0.552 )
        Change at Week 8
    -5.11 ( 0.554 )
        Change at Week 10
    -5.11 ( 0.554 )
        Change at Week 12 (N=110)
    -5.11 ( 0.556 )
    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: • On-treatment virologic failure: o Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or o Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or o 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 2) Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 24
    End point values
    		 SOF/VEL 12 Weeks
    Number of subjects analysed
    111
    Units: percentage of participants
        number (not applicable)
    0.9
    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 12 Weeks
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily

    Serious adverse events
    		 SOF/VEL 12 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 111 (4.50%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gallbladder adenocarcinoma
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 111 (0.90%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lymphangitis
         subjects affected / exposed
    1 / 111 (0.90%)
         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 12 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    46 / 111 (41.44%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    24 / 111 (21.62%)
         occurrences all number
    32
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    18 / 111 (16.22%)
         occurrences all number
    18
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    7 / 111 (6.31%)
         occurrences all number
    7
    Nausea
         subjects affected / exposed
    12 / 111 (10.81%)
         occurrences all number
    12
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 111 (6.31%)
         occurrences all number
    8

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Apr 2015
    Update to concomitant medications to prohibit the use of amiodarone from 60 days prior to Baseline/Day 1 through the end of treatment due to new safety information

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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