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    Clinical Trial Results:
    A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects with Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis

    Summary
    EudraCT number
    		 2016-003066-10
    Trial protocol
    		 FR  
    Global end of trial date
    12 Dec 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Oct 2019
    First version publication date
    25 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-342-4022
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02994056
    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
    12 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Sep 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 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 the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) Class C 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 Jan 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
    France: 6
    Country: Number of subjects enrolled
    United States: 26
    Worldwide total number of subjects
    32
    EEA total number of subjects
    6
    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)
    30
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in the United States and France. The first participant was screened on 23 January 2017. The last study visit occurred on 12 December 2018.

    Pre-assignment
    Screening details
    		 73 participants were screened.

    Period 1
    Period 1 title
    SOF/VEL+ RBV (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 SOF/VEL+ RBV (Total)
    Arm description
    		 SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/velpatasvir
    Investigational medicinal product code
    Other name
    SOF/VEL; Epclusa®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400/100 mg FDC orally once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600-1200 mg based on weight divided twice daily

    Number of subjects in period 1
    		SOF/VEL+ RBV (Total)
    Started
    32
    Completed
    23
    Not completed
    9
         Withdrew Consent
    1
         Death
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOF/VEL+ RBV (Total)
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis

    Reporting group values
    		 SOF/VEL+ RBV (Total) Total
    Number of subjects
    		 32 32
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 55 ( 7.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 26 26
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 7 7
        Not Hispanic or Latino
    		 19 19
        Unkown or Not Reported
    		 6 6
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 1
        Black or African American Native
    		 6 6
        White
    		 18 18
        Not Permitted
    		 6 6
        Other
    		 1 1
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 23 23
        ≥ 800,000 IU/mL
    		 9 9
    IL28B
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 15 15
        CT
    		 14 14
        TT
    		 3 3
    Child-Pugh-Turcotte Class
    CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity.
    Units: Subjects
        CPT B [7-9]
    		 9 9
        CPT C [10-15]
    		 23 23
    Model for End Stage Liver Disease (MELD) Score Category
    MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity.
    Units: Subjects
        10-15 MELD Score
    		 13 13
        16-20 MELD Score
    		 17 17
        21-25 MELD Score
    		 2 2
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 5.2 ( 1.19 ) -

    End points

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    End points reporting groups
    Reporting group title
    SOF/VEL+ RBV (Total)
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis

    Subject analysis set title
    SOF/VEL+ RBV (GT-1)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection and CPT Class C cirrhosis

    Subject analysis set title
    SOF/VEL+ RBV (GT-2)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection and CPT Class C cirrhosis

    Subject analysis set title
    SOF/VEL+ RBV (GT-3)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis

    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. The 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+ RBV (Total) SOF/VEL+ RBV (GT-1) SOF/VEL+ RBV (GT-2) SOF/VEL+ RBV (GT-3)
    Number of subjects analysed
    32
    18
    5
    7
    Units: Percentage of participants
        number (confidence interval 95%)
    78.1 (60.0 to 90.7)
    72.2 (46.5 to 90.3)
    80.0 (28.4 to 99.5)
    85.7 (42.1 to 99.6)
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event

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    End point title
    		 Percentage of Participants Who Permanently Discontinued Study Drug (SOF/VEL or RBV) Due to an Adverse Event [2]
    End point description
    The Safety Analysis Set included all participants who took 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+ RBV (Total)
    Number of subjects analysed
    32
    Units: percentage of participants
    number (not applicable)
        Discontinuation of SOF/VEL
    6.3
        Discontinuation of RBV
    21.9
    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 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+ RBV (Total) SOF/VEL+ RBV (GT-1) SOF/VEL+ RBV (GT-2) SOF/VEL+ RBV (GT-3)
    Number of subjects analysed
    32
    18
    5
    7
    Units: Percentage of participants
        number (confidence interval 95%)
    87.5 (71.0 to 96.5)
    88.9 (65.3 to 98.6)
    80.0 (28.4 to 99.5)
    85.7 (42.1 to 99.6)
    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
    SVR4 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+ RBV (Total) SOF/VEL+ RBV (GT-1) SOF/VEL+ RBV (GT-2) SOF/VEL+ RBV (GT-3)
    Number of subjects analysed
    32
    18
    5
    7
    Units: Percentage of participants
        number (confidence interval 95%)
    75.0 (56.6 to 88.5)
    72.2 (46.5 to 90.3)
    80.0 (28.4 to 99.5)
    71.4 (29.0 to 96.3)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ While on Study Treatment
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, 8, and 12
    End point values
    		 SOF/VEL+ RBV (Total) SOF/VEL+ RBV (GT-1) SOF/VEL+ RBV (GT-2) SOF/VEL+ RBV (GT-3)
    Number of subjects analysed
    32
    18
    5
    7
    Units: Percentage of participants
    number (confidence interval 95%)
        Week 2 (N = 32, 18, 5, 7)
    43.8 (26.4 to 62.3)
    38.9 (17.3 to 64.3)
    0 (0.0 to 52.2)
    71.4 (29.0 to 96.3)
        Week 4 (N = 29, 16, 4, 7)
    96.6 (82.2 to 99.9)
    100.0 (79.4 to 100.0)
    75.0 (19.4 to 99.4)
    100.0 (59.0 to 100.0)
        Week 8 (N = 29, 16, 4, 7)
    100.0 (88.1 to 100.0)
    100.0 (79.4 to 100.0)
    100.0 (39.8 to 100.0)
    100.0 (59.0 to 100.0)
        Week 12 (N = 29, 16, 4, 7)
    100.0 (88.1 to 100.0)
    100.0 (79.4 to 100.0)
    100.0 (39.8 to 100.0)
    100.0 (59.0 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class

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    End point title
    		 Percentage of Participants With Improved and Worsened Child-Pugh-Turcotte (CPT) Class
    End point description
    CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.
    End point type
    Secondary
    End point timeframe
    Baseline to Posttreatment Week 24
    End point values
    		 SOF/VEL+ RBV (Total)
    Number of subjects analysed
    19
    Units: Percentage of participants
    number (not applicable)
        Improved CPT Class
    42.1
        Worsened CPT Class
    0
        No Change CPT Class
    57.9
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score

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    End point title
    		 Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score
    End point description
    MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2. Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Posttreatment Week 24
    End point values
    		 SOF/VEL+ RBV (Total)
    Number of subjects analysed
    19
    Units: Percentage of participants
    number (not applicable)
        Decrease (Improvement)
    52.6
        No Change
    21.1
        Increase (Worsening)
    26.3
    No statistical analyses for this end point

    Secondary: Absolute HCV RNA Level through Week 12

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    End point title
    		 Absolute HCV RNA Level through Week 12
    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+ RBV (Total) SOF/VEL+ RBV (GT-1) SOF/VEL+ RBV (GT-2) SOF/VEL+ RBV (GT-3)
    Number of subjects analysed
    32
    18
    5
    7
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Baseline (N= 32, 18, 5, 7)
    5.17 ( 1.187 )
    5.46 ( 0.537 )
    6.01 ( 0.502 )
    4.84 ( 1.058 )
        Week 2 (N =29, 16, 4, 7)
    1.46 ( 0.392 )
    1.47 ( 0.387 )
    1.63 ( 0.150 )
    1.43 ( 0.526 )
        Week 4 (N = 28, 16, 3, 7)
    1.15 ( 0.000 )
    1.15 ( 0.000 )
    1.15 ( 0.000 )
    1.15 ( 0.000 )
        Week 8 (N = 29, 16, 4, 7)
    1.15 ( 0.000 )
    1.15 ( 0.000 )
    1.15 ( 0.000 )
    1.15 ( 0.000 )
        Week 12 (N = 29, 16, 4, 7)
    1.15 ( 0.000 )
    1.15 ( 0.000 )
    1.15 ( 0.000 )
    1.15 ( 0.000 )
    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+ RBV (Total) SOF/VEL+ RBV (GT-1) SOF/VEL+ RBV (GT-2) SOF/VEL+ RBV (GT-3)
    Number of subjects analysed
    29
    16
    4
    7
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Change at Week 2 (N = 29, 16, 4, 7)
    -3.72 ( 1.092 )
    -4.06 ( 0.531 )
    -4.50 ( 0.366 )
    -3.41 ( 0.665 )
        Change at Week 4 (N = 28, 16, 3, 7)
    -3.99 ( 1.238 )
    -4.39 ( 0.520 )
    -4.88 ( 0.395 )
    -3.70 ( 1.058 )
        Change at Week 8 (N = 29, 16, 4, 7)
    -4.00 ( 1.217 )
    -4.39 ( 0.520 )
    -4.72 ( 0.445 )
    -3.70 ( 1.058 )
        Change at Week 12 (N = 29, 16, 4, 7)
    -4.00 ( 1.217 )
    -4.39 ( 0.520 )
    -4.72 ( 0.445 )
    -3.70 ( 1.058 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Virologic Failure

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    End point title
    		 Number of Participants With Virologic Failure
    End point description
    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. Participants in the Full Analysis Set were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline to Posttreatment Week 12
    End point values
    		 SOF/VEL+ RBV (Total) SOF/VEL+ RBV (GT-1) SOF/VEL+ RBV (GT-2) SOF/VEL+ RBV (GT-3)
    Number of subjects analysed
    32
    18
    5
    7
    Units: participants
        number (not applicable)
    1
    0
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    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 took at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    SOF/VEL+RBV
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis

    Serious adverse events
    		 SOF/VEL+RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 32 (53.13%)
         number of deaths (all causes)
    8
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Mixed hepatocellular cholangiocarcinoma
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Oedema peripheral
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hepatic hydrothorax
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Pleural effusion
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Sepsis
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    Dermo-hypodermitis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 32 (3.13%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 32 (3.13%)
         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+RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 32 (84.38%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 32 (25.00%)
         occurrences all number
    9
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    6 / 32 (18.75%)
         occurrences all number
    6
    Fatigue
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Oedema peripheral
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 32 (25.00%)
         occurrences all number
    8
    Vomiting
         subjects affected / exposed
    5 / 32 (15.63%)
         occurrences all number
    7
    Ascites
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Constipation
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Hepatic hydrothorax
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    6
    Haematuria
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    3 / 32 (9.38%)
         occurrences all number
    3
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2
    Urinary tract infection
         subjects affected / exposed
    2 / 32 (6.25%)
         occurrences all number
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Nov 2016
    • Added hepatitis B surface antibody (HBsAb) and hepatitis B core antibody (HBcAb) assessments to the screening procedures. HBcAb-positive subjects underwent additional hepatitis B virus (HBV) DNA measurements on Day 1; on-treatment Weeks 4, 8, and 12; and posttreatment Weeks 4, 12, and 24 to monitor for HBV reactivation • Added instructions for the upward and downward titration of RBV • Added an inclusion criterion that treatment-experienced individuals must have completed their most recent HCV treatment at least 8 weeks prior to screening • Added guidelines for the use of erythropoiesis-stimulating agents • Added an additional toxicity-based stopping criterion of alanine aminotransferase (ALT) ≥ 15 × upper limit of normal (ULN) • Added the formula for MELD and CPT score calculations

    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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