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    Clinical Trial Results:
    A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection

    Summary
    EudraCT number
    		 2010-020911-35
    Trial protocol
    		 CZ   DE   GB   BE   AT   PL   IT  
    Global end of trial date
    19 Sep 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Mar 2016
    First version publication date
    05 Aug 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-196-0123
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01225380
    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
    19 Sep 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Sep 2013
    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 antiviral efficacy (sustained virologic response [SVR]; defined as undetectable HCV RNA 24 weeks following treatment cessation) of 16 and 24 weeks of response guided duration of therapy with tegobuvir (TGV, GS-9190), GS-9256, ribavirin (RBV), and peginterferon alfa 2a (PEG).
    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
    11 Oct 2010
    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
    Poland: 45
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Austria: 15
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    Czech Republic: 32
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 25
    Country: Number of subjects enrolled
    Italy: 3
    Country: Number of subjects enrolled
    Canada: 46
    Country: Number of subjects enrolled
    United States: 142
    Worldwide total number of subjects
    323
    EEA total number of subjects
    135
    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)
    312
    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 and Europe. The first participant was screened on 11 October 2010. The last study visit occurred on 19 September 2013.

    Pre-assignment
    Screening details
    		 323 participants were screened.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GS-9190+GS-9256
    Arm description
    		 GS-9190+GS-9256+PEG+RBV for 16 or 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration depending on individual response to therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tegobuvir
    Investigational medicinal product code
    Other name
    TGV, GS-9190
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Tegobuvir (TGV) 20 mg capsule administered orally twice daily

    Investigational medicinal product name
    GS-9256
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    GS-9256 150 mg (1 × 100-mg capsule/1 × 50-mg capsule) twice daily

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    PEG, Pegasys®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV, Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) 1000 mg administered orally in a divided daily dose (3 × 200 tablets in the morning, 2 × 200 tablets in the evening)

    Arm title
    		 GS-9256
    Arm description
    		 GS-9256+placebo to match TGV+PEG+RBV for 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration depending on individual response to therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GS-9256
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    GS-9256 150 mg (1 × 100-mg capsule/1 × 50-mg capsule) twice daily

    Investigational medicinal product name
    Tegobuvir placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match tegobuvir administered orally twice daily

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    PEG, Pegasys®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV, Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) 1000 mg administered orally in a divided daily dose (3 × 200 tablets in the morning, 2 × 200 tablets in the evening)

    Arm title
    		 Placebo
    Arm description
    		 Placebo to match GS-9190+placebo to match GS-9256+PEG+RBV for 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tegobuvir placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match tegobuvir administered orally twice daily

    Investigational medicinal product name
    GS-9256 Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match GS-9256 administered orally twice daily

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    PEG, Pegasys®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    RBV, Copegus®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) 1000 mg administered orally in a divided daily dose (3 × 200 tablets in the morning, 2 × 200 tablets in the evening)

    Number of subjects in period 1
    		GS-9190+GS-9256 GS-9256 Placebo
    Started
    163
    78
    82
    Completed
    124
    55
    49
    Not completed
    39
    23
    33
         Efficacy failure
    15
    15
    19
         Consent withdrawn by subject
    7
    3
    2
         Adverse event, non-fatal
    7
    -
    4
         Protocol violation
    3
    -
    -
         Death
    -
    -
    1
         Discontinued by sponsor
    -
    -
    5
         Lost to follow-up
    7
    5
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GS-9190+GS-9256
    Reporting group description
    		 GS-9190+GS-9256+PEG+RBV for 16 or 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration depending on individual response to therapy.

    Reporting group title
    GS-9256
    Reporting group description
    		 GS-9256+placebo to match TGV+PEG+RBV for 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration depending on individual response to therapy.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to match GS-9190+placebo to match GS-9256+PEG+RBV for 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration.

    Reporting group values
    		 GS-9190+GS-9256 GS-9256 Placebo Total
    Number of subjects
    		 163 78 82 323
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 48 ( 11.3 ) 47 ( 12.3 ) 46 ( 12.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 65 31 31 127
        Male
    		 98 47 51 196
    Race
    Units: Subjects
        White
    		 150 69 76 295
        Black or African Heritage
    		 6 6 2 14
        Asian
    		 4 1 2 7
        American Indian or Alaska Native
    		 1 1 1 3
        Native Hawaiian or Pacific Islander
    		 1 0 0 1
        Other
    		 1 1 1 3
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 5 3 8 16
        Not Hispanic/Latino
    		 158 75 74 307
    HCV genotype
    There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes.
    Units: Subjects
        1a
    		 90 42 37 169
        1b
    		 73 36 45 154
    IL28b status
    CC and non-CC alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 53 25 28 106
        Non-CC
    		 110 53 54 217
    Hepatitis C Virus (HCV) RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.36 ( 0.772 ) 6.33 ( 0.672 ) 6.42 ( 0.694 ) -

    End points

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    End points reporting groups
    Reporting group title
    GS-9190+GS-9256
    Reporting group description
    		 GS-9190+GS-9256+PEG+RBV for 16 or 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration depending on individual response to therapy.

    Reporting group title
    GS-9256
    Reporting group description
    		 GS-9256+placebo to match TGV+PEG+RBV for 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration depending on individual response to therapy.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to match GS-9190+placebo to match GS-9256+PEG+RBV for 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration.

    Primary: 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
    End point type
    Primary
    End point timeframe
    Posttreatment Week 24
    End point values
    		 GS-9190+GS-9256 GS-9256 Placebo
    Number of subjects analysed
    163
    78
    82
    Units: percentage of participants
        number (not applicable)
    79.1
    70.5
    54.9
    Statistical analysis title
    		 Difference in rates
    Statistical analysis description
    The total sample size of 160 subjects in Arm 2 and 3 will have 80% power to evaluate superiority of Arm 2 over Arm 3, assuming a 50% response rate in Arm 3 and a 20% treatment effect delta associated with the co-administration of GS-9256, PEG, and RBV.
    Comparison groups
    GS-9256 v Placebo
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.031 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - The p-value comparing achievement of SVR between the GS-9256 and placebo groups is based on the Cochran-Mantel-Haenszel (CMH) test for stratified proportions.

    Secondary: Percentage of Participants With Very Rapid Virologic Response (vRVR)

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    End point title
    		 Percentage of Participants With Very Rapid Virologic Response (vRVR)
    End point description
    vRVR was defined as HCV RNA < 25 IU/mL at Week 2 and Week 4 and HCV RNA < 10 IU/mL at Week 8 maintained through Week 16.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 GS-9190+GS-9256 GS-9256 Placebo
    Number of subjects analysed
    163
    78
    82
    Units: percentage of participants
        number (not applicable)
    72.4
    60.3
    13.4
    Statistical analysis title
    		 Difference in percentage
    Comparison groups
    Placebo v GS-9256
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.001 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - Comparative analysis
    [3] - P-value between the GS-9256 and placebo groups is based on the Cochran-Mantel-Haenszel (CMH) test for stratified proportions.

    Secondary: Percentage of Participants With Extended Rapid Virologic Response (eRVR)

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    End point title
    		 Percentage of Participants With Extended Rapid Virologic Response (eRVR)
    End point description
    eRVR was defined as HCV RNA < 25 IU/mL at Week 4 and HCV RNA < 10 IU/mL at Week 8 maintained through Week 24.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 GS-9190+GS-9256 GS-9256 Placebo
    Number of subjects analysed
    163
    78
    82
    Units: percentage of participants
        number (not applicable)
    82.8
    70.5
    22
    Statistical analysis title
    		 Difference in percentage
    Comparison groups
    GS-9256 v Placebo
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 < 0.001 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [4] - Comparative analysis
    [5] - P-value between the GS-9256 and placebo groups is based on the Cochran-Mantel-Haenszel (CMH) test for stratified proportions.

    Secondary: Percentage of Participants With Partial Early Virologic Response (pEVR)

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    End point title
    		 Percentage of Participants With Partial Early Virologic Response (pEVR)
    End point description
    pEVR was defined as at least a 2 log10 IU/mL reduction from baseline in HCV RNA at Week 12.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 12
    End point values
    		 GS-9190+GS-9256 GS-9256 Placebo
    Number of subjects analysed
    163
    78
    82
    Units: percentage of participants
        number (not applicable)
    93.9
    96.2
    84.1
    Statistical analysis title
    		 Difference in percentage
    Comparison groups
    GS-9256 v Placebo
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.11 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [6] - Comparative analysis
    [7] - P-value between the GS-9256 and placebo groups is based on the Cochran-Mantel-Haenszel (CMH) test for stratified proportions.

    Secondary: Percentage of participants with Virologic Breakthrough and Relapse

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    End point title
    		 Percentage of participants with Virologic Breakthrough and Relapse
    End point description
    Breakthrough was defined as 2 consecutive values that were undetectable followed (at a later point in time) by 2 consecutive detectable HCV RNA values while on treatment. Relapse was defined as undetectable HCV RNA at end of treatment followed by two consecutive detectable HCV RNA values during off-treatment follow-up.
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks
    End point values
    		 GS-9190+GS-9256 GS-9256 Placebo
    Number of subjects analysed
    163
    78
    82
    Units: percentage of participants
    number (not applicable)
        Breakthrough
    1.2
    2.6
    0
        Relapse
    9.2
    11.5
    18.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 48 weeks plus 30 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16..1
    Reporting groups
    Reporting group title
    GS-9190+GS-9256
    Reporting group description
    		 GS-9190+GS-9256+PEG+RBV for 16 or 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration depending on individual response to therapy.

    Reporting group title
    GS-9256
    Reporting group description
    		 GS-9256+placebo to match TGV+PEG+RBV for 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration depending on individual response to therapy.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to match GS-9190+placebo to match GS-9256+PEG+RBV for 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration.

    Serious adverse events
    		 GS-9190+GS-9256 GS-9256 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 163 (6.75%)
    0 / 78 (0.00%)
    5 / 82 (6.10%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 78 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 78 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 78 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Balanitis
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 78 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    0 / 163 (0.00%)
    0 / 78 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Loss of consciousness
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    2 / 163 (1.23%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure acute
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 163 (0.61%)
    0 / 78 (0.00%)
    0 / 82 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GS-9190+GS-9256 GS-9256 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    155 / 163 (95.09%)
    76 / 78 (97.44%)
    79 / 82 (96.34%)
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    83 / 163 (50.92%)
    34 / 78 (43.59%)
    44 / 82 (53.66%)
         occurrences all number
    85
    35
    45
    Pyrexia
         subjects affected / exposed
    43 / 163 (26.38%)
    22 / 78 (28.21%)
    20 / 82 (24.39%)
         occurrences all number
    52
    28
    40
    Chills
         subjects affected / exposed
    35 / 163 (21.47%)
    12 / 78 (15.38%)
    10 / 82 (12.20%)
         occurrences all number
    39
    13
    12
    Irritability
         subjects affected / exposed
    26 / 163 (15.95%)
    13 / 78 (16.67%)
    15 / 82 (18.29%)
         occurrences all number
    26
    13
    15
    Influenza like illness
         subjects affected / exposed
    14 / 163 (8.59%)
    15 / 78 (19.23%)
    14 / 82 (17.07%)
         occurrences all number
    14
    15
    14
    Asthenia
         subjects affected / exposed
    21 / 163 (12.88%)
    10 / 78 (12.82%)
    10 / 82 (12.20%)
         occurrences all number
    21
    12
    11
    Injection site erythema
         subjects affected / exposed
    21 / 163 (12.88%)
    6 / 78 (7.69%)
    10 / 82 (12.20%)
         occurrences all number
    21
    6
    10
    Injection site reaction
         subjects affected / exposed
    10 / 163 (6.13%)
    4 / 78 (5.13%)
    5 / 82 (6.10%)
         occurrences all number
    10
    4
    6
    Pain
         subjects affected / exposed
    7 / 163 (4.29%)
    5 / 78 (6.41%)
    2 / 82 (2.44%)
         occurrences all number
    8
    5
    2
    Chest pain
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 78 (0.00%)
    6 / 82 (7.32%)
         occurrences all number
    3
    0
    7
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    35 / 163 (21.47%)
    11 / 78 (14.10%)
    12 / 82 (14.63%)
         occurrences all number
    36
    12
    14
    Dyspnoea
         subjects affected / exposed
    22 / 163 (13.50%)
    10 / 78 (12.82%)
    8 / 82 (9.76%)
         occurrences all number
    22
    10
    8
    Oropharyngeal pain
         subjects affected / exposed
    9 / 163 (5.52%)
    4 / 78 (5.13%)
    8 / 82 (9.76%)
         occurrences all number
    10
    4
    10
    Dyspnoea exertional
         subjects affected / exposed
    10 / 163 (6.13%)
    5 / 78 (6.41%)
    3 / 82 (3.66%)
         occurrences all number
    10
    5
    3
    Sinus congestion
         subjects affected / exposed
    4 / 163 (2.45%)
    4 / 78 (5.13%)
    1 / 82 (1.22%)
         occurrences all number
    4
    4
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    33 / 163 (20.25%)
    15 / 78 (19.23%)
    15 / 82 (18.29%)
         occurrences all number
    33
    15
    15
    Depression
         subjects affected / exposed
    25 / 163 (15.34%)
    9 / 78 (11.54%)
    10 / 82 (12.20%)
         occurrences all number
    25
    10
    11
    Anxiety
         subjects affected / exposed
    10 / 163 (6.13%)
    6 / 78 (7.69%)
    6 / 82 (7.32%)
         occurrences all number
    10
    7
    6
    Mood swings
         subjects affected / exposed
    6 / 163 (3.68%)
    4 / 78 (5.13%)
    4 / 82 (4.88%)
         occurrences all number
    6
    4
    4
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    20 / 163 (12.27%)
    11 / 78 (14.10%)
    1 / 82 (1.22%)
         occurrences all number
    20
    14
    1
    Weight decreased
         subjects affected / exposed
    8 / 163 (4.91%)
    6 / 78 (7.69%)
    3 / 82 (3.66%)
         occurrences all number
    8
    6
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    66 / 163 (40.49%)
    26 / 78 (33.33%)
    25 / 82 (30.49%)
         occurrences all number
    77
    27
    33
    Dizziness
         subjects affected / exposed
    19 / 163 (11.66%)
    14 / 78 (17.95%)
    12 / 82 (14.63%)
         occurrences all number
    22
    15
    14
    Dysgeusia
         subjects affected / exposed
    17 / 163 (10.43%)
    3 / 78 (3.85%)
    6 / 82 (7.32%)
         occurrences all number
    17
    3
    6
    Disturbance in attention
         subjects affected / exposed
    5 / 163 (3.07%)
    4 / 78 (5.13%)
    2 / 82 (2.44%)
         occurrences all number
    5
    4
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    39 / 163 (23.93%)
    20 / 78 (25.64%)
    12 / 82 (14.63%)
         occurrences all number
    40
    21
    12
    Neutropenia
         subjects affected / exposed
    29 / 163 (17.79%)
    17 / 78 (21.79%)
    15 / 82 (18.29%)
         occurrences all number
    33
    25
    23
    Leukopenia
         subjects affected / exposed
    6 / 163 (3.68%)
    5 / 78 (6.41%)
    1 / 82 (1.22%)
         occurrences all number
    7
    6
    1
    Lymphopenia
         subjects affected / exposed
    4 / 163 (2.45%)
    4 / 78 (5.13%)
    0 / 82 (0.00%)
         occurrences all number
    4
    5
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    15 / 163 (9.20%)
    2 / 78 (2.56%)
    2 / 82 (2.44%)
         occurrences all number
    15
    2
    2
    Eye disorders
    Vision blurred
         subjects affected / exposed
    7 / 163 (4.29%)
    3 / 78 (3.85%)
    5 / 82 (6.10%)
         occurrences all number
    7
    3
    6
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    63 / 163 (38.65%)
    27 / 78 (34.62%)
    20 / 82 (24.39%)
         occurrences all number
    71
    32
    23
    Diarrhoea
         subjects affected / exposed
    34 / 163 (20.86%)
    18 / 78 (23.08%)
    12 / 82 (14.63%)
         occurrences all number
    41
    20
    16
    Vomiting
         subjects affected / exposed
    25 / 163 (15.34%)
    9 / 78 (11.54%)
    5 / 82 (6.10%)
         occurrences all number
    31
    9
    6
    Dyspepsia
         subjects affected / exposed
    16 / 163 (9.82%)
    5 / 78 (6.41%)
    7 / 82 (8.54%)
         occurrences all number
    16
    5
    9
    Abdominal pain
         subjects affected / exposed
    15 / 163 (9.20%)
    8 / 78 (10.26%)
    4 / 82 (4.88%)
         occurrences all number
    16
    9
    5
    Abdominal pain upper
         subjects affected / exposed
    7 / 163 (4.29%)
    4 / 78 (5.13%)
    6 / 82 (7.32%)
         occurrences all number
    7
    4
    7
    Dry mouth
         subjects affected / exposed
    7 / 163 (4.29%)
    6 / 78 (7.69%)
    4 / 82 (4.88%)
         occurrences all number
    7
    6
    4
    Constipation
         subjects affected / exposed
    9 / 163 (5.52%)
    3 / 78 (3.85%)
    1 / 82 (1.22%)
         occurrences all number
    9
    3
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    20 / 163 (12.27%)
    9 / 78 (11.54%)
    0 / 82 (0.00%)
         occurrences all number
    23
    9
    0
    Jaundice
         subjects affected / exposed
    13 / 163 (7.98%)
    3 / 78 (3.85%)
    0 / 82 (0.00%)
         occurrences all number
    13
    3
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    60 / 163 (36.81%)
    15 / 78 (19.23%)
    15 / 82 (18.29%)
         occurrences all number
    67
    15
    17
    Alopecia
         subjects affected / exposed
    48 / 163 (29.45%)
    22 / 78 (28.21%)
    16 / 82 (19.51%)
         occurrences all number
    49
    22
    16
    Rash
         subjects affected / exposed
    39 / 163 (23.93%)
    19 / 78 (24.36%)
    19 / 82 (23.17%)
         occurrences all number
    47
    20
    19
    Dry skin
         subjects affected / exposed
    35 / 163 (21.47%)
    12 / 78 (15.38%)
    6 / 82 (7.32%)
         occurrences all number
    36
    12
    6
    Erythema
         subjects affected / exposed
    11 / 163 (6.75%)
    4 / 78 (5.13%)
    2 / 82 (2.44%)
         occurrences all number
    12
    4
    2
    Pruritus generalised
         subjects affected / exposed
    9 / 163 (5.52%)
    6 / 78 (7.69%)
    2 / 82 (2.44%)
         occurrences all number
    10
    6
    2
    Eczema
         subjects affected / exposed
    8 / 163 (4.91%)
    5 / 78 (6.41%)
    0 / 82 (0.00%)
         occurrences all number
    8
    5
    0
    Rash papular
         subjects affected / exposed
    5 / 163 (3.07%)
    2 / 78 (2.56%)
    6 / 82 (7.32%)
         occurrences all number
    5
    2
    7
    Rash pruritic
         subjects affected / exposed
    3 / 163 (1.84%)
    0 / 78 (0.00%)
    6 / 82 (7.32%)
         occurrences all number
    3
    0
    7
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    11 / 163 (6.75%)
    4 / 78 (5.13%)
    2 / 82 (2.44%)
         occurrences all number
    12
    4
    2
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    37 / 163 (22.70%)
    8 / 78 (10.26%)
    11 / 82 (13.41%)
         occurrences all number
    39
    9
    18
    Arthralgia
         subjects affected / exposed
    25 / 163 (15.34%)
    9 / 78 (11.54%)
    12 / 82 (14.63%)
         occurrences all number
    26
    12
    15
    Back pain
         subjects affected / exposed
    11 / 163 (6.75%)
    7 / 78 (8.97%)
    13 / 82 (15.85%)
         occurrences all number
    12
    7
    14
    Muscle spasms
         subjects affected / exposed
    14 / 163 (8.59%)
    4 / 78 (5.13%)
    5 / 82 (6.10%)
         occurrences all number
    15
    4
    5
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    2 / 163 (1.23%)
    2 / 78 (2.56%)
    6 / 82 (7.32%)
         occurrences all number
    2
    2
    7
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    40 / 163 (24.54%)
    15 / 78 (19.23%)
    14 / 82 (17.07%)
         occurrences all number
    41
    15
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Aug 2010
    A genotypic resistance analysis was included for the viral population in Arm 1 vRVR subjects who relapsed and, in combination with unblinded IL28B genotype data, investigators were allowed to use this information in the decision-making process for retreatment. The following virologic stopping rules were included: (1) confirmed ≥ 1 log10 IU/mL HCV RNA increase from nadir between Weeks 4 and 24 with an absolute value > 1000 IU/mL and (2) confirmed detectable HCV RNA after 2 consecutive visits in which HCV RNA level was undetectable.
    10 Nov 2010
    Based on FDA advice, a confirmatory assessment of plasma HCV RNA within approximately 2 weeks was added for subjects with evidence of possible virologic breakthrough but not yet meeting a protocol-defined treatment stopping rule. The initial Data Monitoring Committee (DMC) review of data was planned to occur after the first 40 subjects enrolled completed through Week 12. To allow for an earlier DMC assessment of subject safety and study integrity, the protocol was amended to conduct this initial DMC review after the first 40 subjects enrolled had completed through Week 4.
    15 Sep 2011
    In consultation with the FDA, the decision was made to discontinue dosing of TGV when given in combination with Peg-IFN+RBV and another DAA across all active Gilead studies.

    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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