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    Clinical Trial Results:
    A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of a Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection (Protocol GS-US-196-0140)

    Summary
    EudraCT number
    		 2010-023952-10
    Trial protocol
    		 DE   BE   GB   AT  
    Global end of trial date
    17 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

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    Trial identification
    Sponsor protocol code
    GS-US-196-0140
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01271790
    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
    17 Sep 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 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 a 3-drug regimen of GS-9451 with peginterferon alfa 2a (PEG) and ribavirin (RBV) followed by response guided PEG/RBV versus a control arm of PEG/RBV therapy for 48 weeks.
    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
    10 Dec 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: 25
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Belgium: 7
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    United States: 201
    Worldwide total number of subjects
    239
    EEA total number of subjects
    38
    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)
    235
    From 65 to 84 years
    4
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Europe and North America. The first participant was screened on 10 December 2010. The last study visit occurred on 17 September 2013.

    Pre-assignment
    Screening details
    		 239 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
    		 VDV+TGV+Peg-IFN+RBV
    Arm description
    		 VDV+TGV+Peg-IFN+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
    Vedroprevir
    Investigational medicinal product code
    Other name
    VDV, GS-9451
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Vedroprevir (VDV) 200 mg (2 × 100 mg tablets) administered orally once daily

    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) 30 mg tablet administered orally twice daily

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    Peg-IFN, Pegasys®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Peg-IFN 180 μg administered subcutaneously once weekly

    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) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Arm title
    		 VDV+Peg-IFN+RBV
    Arm description
    		 VDV+placebo to match TGV+Peg-IFN+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
    Vedroprevir
    Investigational medicinal product code
    Other name
    VDV, GS-9451
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Vedroprevir (VDV) 200 mg (2 × 100 mg tablets) administered orally once 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 TGV administered orally twice daily

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    Peg-IFN, Pegasys®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Peg-IFN 180 μg administered subcutaneously once weekly

    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) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Arm title
    		 Peg-IFN+RBV
    Arm description
    		 Placebo to match VDV+placebo to match TGV+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
    Vedroprevir placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match VDV administered orally once 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 TGV administered orally twice daily

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    Peg-IFN, Pegasys®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Peg-IFN 180 μg administered subcutaneously once weekly

    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) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

    Number of subjects in period 1
    		VDV+TGV+Peg-IFN+RBV VDV+Peg-IFN+RBV Peg-IFN+RBV
    Started
    119
    59
    61
    Completed
    72
    32
    31
    Not completed
    47
    27
    30
         Efficacy failure
    25
    12
    13
         Participant withdrew consent
    8
    6
    4
         Adverse event, non-fatal
    4
    4
    5
         Protocol violation
    -
    -
    1
         Death
    -
    -
    1
         Lost to follow-up
    9
    4
    5
         Investigator's discretion
    1
    1
    -
         Study discontinued by sponsor
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    VDV+TGV+Peg-IFN+RBV
    Reporting group description
    		 VDV+TGV+Peg-IFN+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
    VDV+Peg-IFN+RBV
    Reporting group description
    		 VDV+placebo to match TGV+Peg-IFN+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
    Peg-IFN+RBV
    Reporting group description
    		 Placebo to match VDV+placebo to match TGV+PEG+RBV for 24 weeks; PEG+RBV may have been continued for up to 48 weeks total duration.

    Reporting group values
    		 VDV+TGV+Peg-IFN+RBV VDV+Peg-IFN+RBV Peg-IFN+RBV Total
    Number of subjects
    		 119 59 61 239
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 47 ( 11.6 ) 48 ( 11.2 ) 46 ( 12.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 44 28 23 95
        Male
    		 75 31 38 144
    Race
    Units: Subjects
        White
    		 104 46 46 196
        Black or African Heritage
    		 14 9 9 32
        Asian
    		 1 2 4 7
        American Indian or Alaska Native
    		 0 1 0 1
        Other
    		 0 0 2 2
        Not Permitted
    		 0 1 0 1
    Ethnicity
    Units: Subjects
        Hispanic/Latino
    		 8 3 4 15
        Non-Hispanic/Latino
    		 110 56 56 222
        Not Permitted
    		 1 0 1 2
    HCV RNA Category
    Units: Subjects
        ≤ 800,000 IU/mL
    		 20 11 11 42
        > 800,000 IU/mL
    		 99 48 50 197
    HCV Genotype
    Units: Subjects
        Genotype 1a
    		 81 39 45 165
        Genotype 1b
    		 38 20 16 74
    IL28b status
    CC and non-CC alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 34 18 20 72
        non-CC
    		 85 41 41 167
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.46 ( 0.752 ) 6.55 ( 0.559 ) 6.54 ( 0.65 ) -

    End points

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    End points reporting groups
    Reporting group title
    VDV+TGV+Peg-IFN+RBV
    Reporting group description
    		 VDV+TGV+Peg-IFN+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
    VDV+Peg-IFN+RBV
    Reporting group description
    		 VDV+placebo to match TGV+Peg-IFN+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
    Peg-IFN+RBV
    Reporting group description
    		 Placebo to match VDV+placebo to match TGV+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
    SVR was defined as HCV RNA < 10 IU/mL 24 weeks following the last dose of study drug.
    End point type
    Primary
    End point timeframe
    Postttreatment Week 24
    End point values
    		 VDV+TGV+Peg-IFN+RBV VDV+Peg-IFN+RBV Peg-IFN+RBV
    Number of subjects analysed
    119
    59
    61
    Units: Percentage of participants
        number (not applicable)
    64.7
    55.9
    44.3
    Statistical analysis title
    		 Difference in percentage
    Comparison groups
    Peg-IFN+RBV v VDV+Peg-IFN+RBV
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.168 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - A total sample size of 160 subjects (80 per arm) in Arms 2 and 3 would have approximately 80% power to evaluate superiority of the VDV+Peg-IFN+RBV arm over the Peg-IFN+RBV arm.
    [2] - The p-value comparing achievement of SVR is based on the Cochran-Mantel-Haenszel 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
    		 VDV+TGV+Peg-IFN+RBV VDV+Peg-IFN+RBV Peg-IFN+RBV
    Number of subjects analysed
    119
    59
    61
    Units: Percentage of participants
        number (not applicable)
    56.3
    33.9
    6.6
    Statistical analysis title
    		 Difference in percentage
    Comparison groups
    VDV+Peg-IFN+RBV v Peg-IFN+RBV
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 < 0.001 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [3] - Comparative analysis
    [4] - The p-value is based on the Cochran-Mantel-Haenszel 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
    		 VDV+TGV+Peg-IFN+RBV VDV+Peg-IFN+RBV Peg-IFN+RBV
    Number of subjects analysed
    119
    59
    61
    Units: Percentage of participants
        number (not applicable)
    69.7
    61
    23
    Statistical analysis title
    		 Difference in percentage
    Comparison groups
    Peg-IFN+RBV v VDV+Peg-IFN+RBV
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 < 0.001 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [5] - Comparative analysis
    [6] - The p-value is based on the Cochran-Mantel-Haenszel 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
    		 VDV+TGV+Peg-IFN+RBV VDV+Peg-IFN+RBV Peg-IFN+RBV
    Number of subjects analysed
    119
    59
    61
    Units: Percentage of participants
        number (not applicable)
    91.6
    88.1
    80.3
    Statistical analysis title
    		 Difference in percentage
    Comparison groups
    VDV+Peg-IFN+RBV v Peg-IFN+RBV
    Number of subjects included in analysis
    120
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.215 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [7] - Comparative analysis
    [8] - The p-value is based on the Cochran-Mantel-Haenszel 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
    		 VDV+TGV+Peg-IFN+RBV VDV+Peg-IFN+RBV Peg-IFN+RBV
    Number of subjects analysed
    119
    59
    61
    Units: Percentage of participants
    number (not applicable)
        Breakthrough
    4.2
    1.7
    1.6
        Relapse
    12.6
    20.3
    9.8
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 24 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
    TGV+VDV+Peg-IFN+RBV
    Reporting group description
    		 TGV+VDV+Peg-IFN+RBV for 16 or 24 weeks followed by response-guided therapy with Peg-IFN+RBV

    Reporting group title
    VDV+Peg-IFN+RBV
    Reporting group description
    		 VDV+placebo to match TGV+Peg-IFN+RBV for 24 weeks followed by response-guided therapy with Peg-IFN+RBV

    Reporting group title
    Peg-IFN+RBV
    Reporting group description
    		 Placebo to match VDV+placebo to match TGV+Peg-IFN+RBV for 24 weeks followed by Peg-IFN+RBV for 24 weeks

    Serious adverse events
    		 TGV+VDV+Peg-IFN+RBV VDV+Peg-IFN+RBV Peg-IFN+RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 119 (2.52%)
    3 / 59 (5.08%)
    2 / 61 (3.28%)
         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)
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Injury
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Aplastic anaemia
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 59 (0.00%)
    0 / 61 (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 / 119 (0.84%)
    0 / 59 (0.00%)
    0 / 61 (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
    Pancytopenia
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 59 (0.00%)
    0 / 61 (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
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 59 (0.00%)
    0 / 61 (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
    Eye disorders
    Retinal exudates
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 59 (0.00%)
    0 / 61 (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
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 59 (1.69%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         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
    		 TGV+VDV+Peg-IFN+RBV VDV+Peg-IFN+RBV Peg-IFN+RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    116 / 119 (97.48%)
    59 / 59 (100.00%)
    59 / 61 (96.72%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    2 / 119 (1.68%)
    3 / 59 (5.08%)
    1 / 61 (1.64%)
         occurrences all number
    2
    3
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    65 / 119 (54.62%)
    29 / 59 (49.15%)
    34 / 61 (55.74%)
         occurrences all number
    66
    29
    35
    Pyrexia
         subjects affected / exposed
    21 / 119 (17.65%)
    11 / 59 (18.64%)
    14 / 61 (22.95%)
         occurrences all number
    27
    12
    14
    Chills
         subjects affected / exposed
    18 / 119 (15.13%)
    7 / 59 (11.86%)
    14 / 61 (22.95%)
         occurrences all number
    21
    7
    15
    Irritability
         subjects affected / exposed
    18 / 119 (15.13%)
    8 / 59 (13.56%)
    9 / 61 (14.75%)
         occurrences all number
    19
    8
    9
    Injection site reaction
         subjects affected / exposed
    13 / 119 (10.92%)
    6 / 59 (10.17%)
    15 / 61 (24.59%)
         occurrences all number
    13
    6
    16
    Influenza like illness
         subjects affected / exposed
    13 / 119 (10.92%)
    5 / 59 (8.47%)
    10 / 61 (16.39%)
         occurrences all number
    14
    6
    11
    Pain
         subjects affected / exposed
    7 / 119 (5.88%)
    4 / 59 (6.78%)
    9 / 61 (14.75%)
         occurrences all number
    13
    4
    9
    Asthenia
         subjects affected / exposed
    6 / 119 (5.04%)
    3 / 59 (5.08%)
    7 / 61 (11.48%)
         occurrences all number
    7
    4
    7
    Chest discomfort
         subjects affected / exposed
    2 / 119 (1.68%)
    3 / 59 (5.08%)
    0 / 61 (0.00%)
         occurrences all number
    2
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    22 / 119 (18.49%)
    9 / 59 (15.25%)
    9 / 61 (14.75%)
         occurrences all number
    24
    10
    11
    Dyspnoea
         subjects affected / exposed
    24 / 119 (20.17%)
    4 / 59 (6.78%)
    4 / 61 (6.56%)
         occurrences all number
    24
    4
    4
    Oropharyngeal pain
         subjects affected / exposed
    7 / 119 (5.88%)
    3 / 59 (5.08%)
    5 / 61 (8.20%)
         occurrences all number
    7
    3
    6
    Dyspnoea exertional
         subjects affected / exposed
    8 / 119 (6.72%)
    1 / 59 (1.69%)
    3 / 61 (4.92%)
         occurrences all number
    8
    1
    3
    Epistaxis
         subjects affected / exposed
    2 / 119 (1.68%)
    1 / 59 (1.69%)
    4 / 61 (6.56%)
         occurrences all number
    2
    2
    4
    Nasal congestion
         subjects affected / exposed
    0 / 119 (0.00%)
    3 / 59 (5.08%)
    1 / 61 (1.64%)
         occurrences all number
    0
    3
    1
    Wheezing
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 59 (0.00%)
    4 / 61 (6.56%)
         occurrences all number
    0
    0
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    32 / 119 (26.89%)
    16 / 59 (27.12%)
    13 / 61 (21.31%)
         occurrences all number
    32
    17
    13
    Depression
         subjects affected / exposed
    29 / 119 (24.37%)
    8 / 59 (13.56%)
    12 / 61 (19.67%)
         occurrences all number
    29
    8
    12
    Anxiety
         subjects affected / exposed
    9 / 119 (7.56%)
    11 / 59 (18.64%)
    3 / 61 (4.92%)
         occurrences all number
    9
    12
    3
    Investigations
    Weight decreased
         subjects affected / exposed
    7 / 119 (5.88%)
    2 / 59 (3.39%)
    5 / 61 (8.20%)
         occurrences all number
    7
    2
    6
    Neutrophil count decreased
         subjects affected / exposed
    5 / 119 (4.20%)
    3 / 59 (5.08%)
    1 / 61 (1.64%)
         occurrences all number
    6
    3
    3
    Haemoglobin decreased
         subjects affected / exposed
    3 / 119 (2.52%)
    3 / 59 (5.08%)
    0 / 61 (0.00%)
         occurrences all number
    3
    4
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    2 / 119 (1.68%)
    3 / 59 (5.08%)
    0 / 61 (0.00%)
         occurrences all number
    2
    4
    0
    White blood cell count decreased
         subjects affected / exposed
    2 / 119 (1.68%)
    3 / 59 (5.08%)
    0 / 61 (0.00%)
         occurrences all number
    2
    3
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 119 (0.84%)
    3 / 59 (5.08%)
    0 / 61 (0.00%)
         occurrences all number
    1
    3
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    56 / 119 (47.06%)
    23 / 59 (38.98%)
    23 / 61 (37.70%)
         occurrences all number
    69
    27
    32
    Dizziness
         subjects affected / exposed
    10 / 119 (8.40%)
    6 / 59 (10.17%)
    8 / 61 (13.11%)
         occurrences all number
    10
    6
    9
    Dysgeusia
         subjects affected / exposed
    8 / 119 (6.72%)
    3 / 59 (5.08%)
    5 / 61 (8.20%)
         occurrences all number
    8
    3
    5
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    33 / 119 (27.73%)
    15 / 59 (25.42%)
    21 / 61 (34.43%)
         occurrences all number
    37
    21
    25
    Anaemia
         subjects affected / exposed
    26 / 119 (21.85%)
    15 / 59 (25.42%)
    17 / 61 (27.87%)
         occurrences all number
    29
    15
    20
    Leukopenia
         subjects affected / exposed
    8 / 119 (6.72%)
    3 / 59 (5.08%)
    5 / 61 (8.20%)
         occurrences all number
    9
    5
    5
    Thrombocytopenia
         subjects affected / exposed
    7 / 119 (5.88%)
    2 / 59 (3.39%)
    2 / 61 (3.28%)
         occurrences all number
    7
    2
    2
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    6 / 119 (5.04%)
    3 / 59 (5.08%)
    5 / 61 (8.20%)
         occurrences all number
    6
    3
    5
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 119 (0.00%)
    3 / 59 (5.08%)
    1 / 61 (1.64%)
         occurrences all number
    0
    3
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    44 / 119 (36.97%)
    22 / 59 (37.29%)
    19 / 61 (31.15%)
         occurrences all number
    49
    23
    21
    Diarrhoea
         subjects affected / exposed
    30 / 119 (25.21%)
    7 / 59 (11.86%)
    10 / 61 (16.39%)
         occurrences all number
    35
    7
    10
    Dyspepsia
         subjects affected / exposed
    11 / 119 (9.24%)
    2 / 59 (3.39%)
    5 / 61 (8.20%)
         occurrences all number
    11
    2
    5
    Vomiting
         subjects affected / exposed
    12 / 119 (10.08%)
    3 / 59 (5.08%)
    3 / 61 (4.92%)
         occurrences all number
    14
    4
    3
    Abdominal pain
         subjects affected / exposed
    8 / 119 (6.72%)
    3 / 59 (5.08%)
    2 / 61 (3.28%)
         occurrences all number
    10
    3
    3
    Abdominal pain upper
         subjects affected / exposed
    6 / 119 (5.04%)
    2 / 59 (3.39%)
    4 / 61 (6.56%)
         occurrences all number
    6
    2
    4
    Constipation
         subjects affected / exposed
    5 / 119 (4.20%)
    4 / 59 (6.78%)
    3 / 61 (4.92%)
         occurrences all number
    5
    5
    3
    Dry mouth
         subjects affected / exposed
    4 / 119 (3.36%)
    3 / 59 (5.08%)
    0 / 61 (0.00%)
         occurrences all number
    4
    3
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    33 / 119 (27.73%)
    9 / 59 (15.25%)
    18 / 61 (29.51%)
         occurrences all number
    43
    12
    21
    Alopecia
         subjects affected / exposed
    23 / 119 (19.33%)
    9 / 59 (15.25%)
    15 / 61 (24.59%)
         occurrences all number
    23
    9
    15
    Pruritus
         subjects affected / exposed
    20 / 119 (16.81%)
    9 / 59 (15.25%)
    11 / 61 (18.03%)
         occurrences all number
    23
    9
    12
    Dry skin
         subjects affected / exposed
    10 / 119 (8.40%)
    3 / 59 (5.08%)
    9 / 61 (14.75%)
         occurrences all number
    10
    3
    9
    Pruritus generalised
         subjects affected / exposed
    5 / 119 (4.20%)
    4 / 59 (6.78%)
    1 / 61 (1.64%)
         occurrences all number
    5
    4
    1
    Rash pruritic
         subjects affected / exposed
    5 / 119 (4.20%)
    3 / 59 (5.08%)
    1 / 61 (1.64%)
         occurrences all number
    5
    3
    1
    Rash papular
         subjects affected / exposed
    2 / 119 (1.68%)
    3 / 59 (5.08%)
    3 / 61 (4.92%)
         occurrences all number
    2
    3
    3
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    3 / 119 (2.52%)
    3 / 59 (5.08%)
    2 / 61 (3.28%)
         occurrences all number
    3
    3
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    28 / 119 (23.53%)
    11 / 59 (18.64%)
    8 / 61 (13.11%)
         occurrences all number
    32
    11
    8
    Myalgia
         subjects affected / exposed
    22 / 119 (18.49%)
    11 / 59 (18.64%)
    14 / 61 (22.95%)
         occurrences all number
    23
    12
    14
    Back pain
         subjects affected / exposed
    9 / 119 (7.56%)
    5 / 59 (8.47%)
    3 / 61 (4.92%)
         occurrences all number
    9
    5
    3
    Muscle spasms
         subjects affected / exposed
    7 / 119 (5.88%)
    3 / 59 (5.08%)
    3 / 61 (4.92%)
         occurrences all number
    7
    3
    3
    Infections and infestations
    Sinusitis
         subjects affected / exposed
    6 / 119 (5.04%)
    2 / 59 (3.39%)
    4 / 61 (6.56%)
         occurrences all number
    8
    3
    5
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 119 (3.36%)
    3 / 59 (5.08%)
    5 / 61 (8.20%)
         occurrences all number
    5
    3
    5
    Bronchitis
         subjects affected / exposed
    8 / 119 (6.72%)
    0 / 59 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    8
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    23 / 119 (19.33%)
    8 / 59 (13.56%)
    11 / 61 (18.03%)
         occurrences all number
    23
    8
    12

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2010
    Protocol was amended to limit to the number of genotype 1a and 1b subjects to no more than 70% of subjects, to include a confirmatory assessment of plasma HCV RNA within approximately 2 weeks in such cases, and to prohibit the use of Pgp substrates with narrow therapeutic indices, including digoxin and colchicine; 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 Week 4 of the study.
    15 Sep 2011
    In consultation with the FDA, discontinued dosing of tegobuvir 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.
    There were no limitations affecting the analysis or results.
    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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