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    Clinical Trial Results:
    An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

    Summary
    EudraCT number
    		 2012-000571-16
    Trial protocol
    		 AT   GB   SE   EE   DE   NL   ES   PL   CZ  
    Global end of trial date
    22 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 May 2016
    First version publication date
    13 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-334-0109
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01625338
    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 Information Desk, Gilead Sciences International Ltd, +44 1223897 496, clinical.trials@gilead.com
    Scientific contact
    Clinical Trial Information Desk, Gilead Sciences International Ltd, +44 1223897 496, clinical.trials@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
    22 Dec 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).
    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
    22 Jun 2012
    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
    Netherlands: 10
    Country: Number of subjects enrolled
    Poland: 9
    Country: Number of subjects enrolled
    Spain: 11
    Country: Number of subjects enrolled
    Sweden: 10
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Estonia: 6
    Country: Number of subjects enrolled
    France: 23
    Country: Number of subjects enrolled
    Germany: 33
    Country: Number of subjects enrolled
    Italy: 14
    Country: Number of subjects enrolled
    United States: 280
    Country: Number of subjects enrolled
    New Zealand: 40
    Country: Number of subjects enrolled
    Canada: 30
    Country: Number of subjects enrolled
    Australia: 42
    Worldwide total number of subjects
    534
    EEA total number of subjects
    142
    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)
    502
    From 65 to 84 years
    32
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at a total of 152 study sites from their prior Gilead study in North America, Europe, Australia, and New Zealand. The first participant was screened on 22 June 2012. The last study visit occurred on 22 December 2014.

    Pre-assignment
    Screening details
    		 585 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SOF+RBV 12 Weeks
    Arm description
    		 SOF+RBV for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®, GS-7977, PSI-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sofosbuvir (SOF) 400 mg once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) 1000 or 1200 mg daily based on weight

    Arm title
    		 SOF+RBV 24 Weeks
    Arm description
    		 SOF+RBV for 24 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®, GS-7977, PSI-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sofosbuvir (SOF) 400 mg once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) 1000 or 1200 mg daily based on weight

    Arm title
    		 SOF+RBV+Peg-IFN 12 Weeks
    Arm description
    		 SOF+RBV+Peg-IFN for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®, GS-7977, PSI-7977
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Sofosbuvir (SOF) 400 mg once daily

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin (RBV) 1000 or 1200 mg daily based on weight

    Investigational medicinal product name
    Pegylated interferon
    Investigational medicinal product code
    Other name
    PEGASYS®
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pegylated interferon (Peg-IFN) 180 µg once weekly

    Number of subjects in period 1 [1]
    		SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Started
    114
    200
    219
    Completed
    82
    156
    181
    Not completed
    32
    44
    38
         Subject Withdrew Consent
    1
    -
    2
         Adverse event, non-fatal
    1
    -
    1
         Efficacy Failure
    27
    39
    31
         Study Discontinued by Sponsor
    -
    -
    1
         Investigator Decision
    -
    2
    1
         Lost to follow-up
    3
    3
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One participant who was enrolled but not treated is not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOF+RBV 12 Weeks
    Reporting group description
    		 SOF+RBV for 12 weeks

    Reporting group title
    SOF+RBV 24 Weeks
    Reporting group description
    		 SOF+RBV for 24 weeks

    Reporting group title
    SOF+RBV+Peg-IFN 12 Weeks
    Reporting group description
    		 SOF+RBV+Peg-IFN for 12 weeks

    Reporting group values
    		 SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks Total
    Number of subjects
    		 114 200 219 533
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53 ( 9.6 ) 52 ( 7.6 ) 53 ( 10 ) -
    Gender categorical
    Units: Subjects
        Female
    		 54 50 60 164
        Male
    		 60 150 159 369
    Race
    Units: Subjects
        White
    		 105 184 187 476
        Black Or African American
    		 4 2 20 26
        Asian
    		 2 6 8 16
        Other
    		 1 3 2 6
        Not Permitted
    		 0 2 2 4
        American Indian Or Alaska Native
    		 2 1 0 3
        Native Hawaiian Or Other Pacific Islander
    		 0 2 0 2
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 19 12 20 51
        Not Hispanic or Latino
    		 95 187 197 479
        Not Permitted
    		 0 1 2 3
    HCV Genotype
    Units: Subjects
        Genotype 1
    		 0 2 134 136
        Genotype 2
    		 62 10 8 80
        Genotype 3
    		 52 180 74 306
        Genotype 4
    		 0 7 3 10
        Indeterminate
    		 0 1 0 1
    Cirrhosis Status
    Units: Subjects
        No
    		 89 138 183 410
        Yes
    		 25 62 36 123
    IL28b Status
    CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 38 59 47 144
        CT
    		 61 103 127 291
        TT
    		 13 35 40 88
        Missing
    		 2 3 5 10
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 30 44 36 110
        ≥ 800,000 IU/mL
    		 84 156 183 423
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.3 ( 0.87 ) 6.4 ( 0.7 ) 6.4 ( 0.64 ) -

    End points

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    End points reporting groups
    Reporting group title
    SOF+RBV 12 Weeks
    Reporting group description
    		 SOF+RBV for 12 weeks

    Reporting group title
    SOF+RBV 24 Weeks
    Reporting group description
    		 SOF+RBV for 24 weeks

    Reporting group title
    SOF+RBV+Peg-IFN 12 Weeks
    Reporting group description
    		 SOF+RBV+Peg-IFN for 12 weeks

    Primary: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

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    End point title
    		 Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [1]
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment. Full Analysis Set: participants who were enrolled and received 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+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    114
    200
    219
    Units: percentage of participants
        number (not applicable)
    71.9
    77.5
    82.6
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [2]
    End point description
    Safety Analysis Set: participants who were enrolled and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    114
    200
    219
    Units: percentage of participants]
        number (not applicable)
    0.9
    1
    3.7
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    End point description
    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    114
    200
    219
    Units: percentage of participants
    number (not applicable)
        SVR4
    73.7
    81.5
    87.2
        SVR24
    71.9
    76
    82.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants With On-treatment Virologic Failure

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    End point title
    		 Percentage of Participants With On-treatment Virologic Failure
    End point description
    On-treatment virologic failure was defined as • 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) Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks
    End point values
    		 SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    114
    200
    219
    Units: percentage of participants
        number (not applicable)
    0.9
    0.5
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Viral Relapse

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    End point title
    		 Percentage of Participants With Viral Relapse
    End point description
    Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 24
    End point values
    		 SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Number of subjects analysed
    113
    199
    219
    Units: percentage of participants
        number (not applicable)
    25.7
    20.6
    16.4
    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
    Adverse event reporting additional description
    Safety Analysis Set
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    SOF+RBV 12 Weeks
    Reporting group description
    		 SOF+RBV for 12 weeks

    Reporting group title
    SOF+RBV 24 Weeks
    Reporting group description
    		 SOF+RBV for 24 weeks

    Reporting group title
    SOF+RBV+Peg-IFN 12 Weeks
    Reporting group description
    		 SOF+RBV+Peg-IFN for 12 weeks

    Serious adverse events
    		 SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 114 (3.51%)
    11 / 200 (5.50%)
    4 / 219 (1.83%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 114 (0.88%)
    1 / 200 (0.50%)
    0 / 219 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ligament rupture
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Multiple injuries
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 200 (0.00%)
    0 / 219 (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
    Road traffic accident
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Presyncope
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Myelitis transverse
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 200 (0.00%)
    0 / 219 (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
    Social circumstances
    Social stay hospitalisation
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Dysphagia
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 200 (0.00%)
    1 / 219 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 200 (0.00%)
    1 / 219 (0.46%)
         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
    Suicide attempt
         subjects affected / exposed
    1 / 114 (0.88%)
    0 / 200 (0.00%)
    1 / 219 (0.46%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Affective disorder
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Insomnia
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Mania
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Psychotic disorder
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Substance-induced psychotic disorder
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 200 (0.00%)
    1 / 219 (0.46%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Meningitis aseptic
         subjects affected / exposed
    0 / 114 (0.00%)
    1 / 200 (0.50%)
    0 / 219 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SOF+RBV 12 Weeks SOF+RBV 24 Weeks SOF+RBV+Peg-IFN 12 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    92 / 114 (80.70%)
    167 / 200 (83.50%)
    194 / 219 (88.58%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    15 / 114 (13.16%)
    57 / 200 (28.50%)
    71 / 219 (32.42%)
         occurrences all number
    15
    64
    75
    Dizziness
         subjects affected / exposed
    4 / 114 (3.51%)
    13 / 200 (6.50%)
    23 / 219 (10.50%)
         occurrences all number
    4
    13
    25
    Dysgeusia
         subjects affected / exposed
    3 / 114 (2.63%)
    0 / 200 (0.00%)
    12 / 219 (5.48%)
         occurrences all number
    3
    0
    12
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    13 / 114 (11.40%)
    12 / 200 (6.00%)
    26 / 219 (11.87%)
         occurrences all number
    13
    13
    27
    Neutropenia
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 200 (0.00%)
    38 / 219 (17.35%)
         occurrences all number
    0
    0
    40
    Leukopenia
         subjects affected / exposed
    0 / 114 (0.00%)
    0 / 200 (0.00%)
    11 / 219 (5.02%)
         occurrences all number
    0
    0
    12
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    33 / 114 (28.95%)
    66 / 200 (33.00%)
    97 / 219 (44.29%)
         occurrences all number
    34
    71
    99
    Influenza like illness
         subjects affected / exposed
    6 / 114 (5.26%)
    5 / 200 (2.50%)
    45 / 219 (20.55%)
         occurrences all number
    6
    5
    52
    Asthenia
         subjects affected / exposed
    5 / 114 (4.39%)
    9 / 200 (4.50%)
    19 / 219 (8.68%)
         occurrences all number
    5
    9
    20
    Pyrexia
         subjects affected / exposed
    5 / 114 (4.39%)
    1 / 200 (0.50%)
    27 / 219 (12.33%)
         occurrences all number
    6
    1
    36
    Chills
         subjects affected / exposed
    2 / 114 (1.75%)
    3 / 200 (1.50%)
    19 / 219 (8.68%)
         occurrences all number
    2
    3
    23
    Pain
         subjects affected / exposed
    2 / 114 (1.75%)
    4 / 200 (2.00%)
    17 / 219 (7.76%)
         occurrences all number
    2
    4
    18
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    22 / 114 (19.30%)
    27 / 200 (13.50%)
    52 / 219 (23.74%)
         occurrences all number
    22
    29
    53
    Diarrhoea
         subjects affected / exposed
    7 / 114 (6.14%)
    14 / 200 (7.00%)
    28 / 219 (12.79%)
         occurrences all number
    7
    14
    35
    Vomiting
         subjects affected / exposed
    7 / 114 (6.14%)
    7 / 200 (3.50%)
    9 / 219 (4.11%)
         occurrences all number
    7
    10
    14
    Abdominal pain
         subjects affected / exposed
    6 / 114 (5.26%)
    7 / 200 (3.50%)
    5 / 219 (2.28%)
         occurrences all number
    7
    8
    5
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 114 (9.65%)
    11 / 200 (5.50%)
    33 / 219 (15.07%)
         occurrences all number
    11
    11
    33
    Dyspnoea
         subjects affected / exposed
    6 / 114 (5.26%)
    12 / 200 (6.00%)
    11 / 219 (5.02%)
         occurrences all number
    6
    14
    11
    Dyspnoea exertional
         subjects affected / exposed
    5 / 114 (4.39%)
    7 / 200 (3.50%)
    13 / 219 (5.94%)
         occurrences all number
    5
    7
    13
    Oropharyngeal pain
         subjects affected / exposed
    3 / 114 (2.63%)
    4 / 200 (2.00%)
    12 / 219 (5.48%)
         occurrences all number
    3
    4
    12
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    15 / 114 (13.16%)
    23 / 200 (11.50%)
    40 / 219 (18.26%)
         occurrences all number
    15
    24
    40
    Rash
         subjects affected / exposed
    13 / 114 (11.40%)
    19 / 200 (9.50%)
    35 / 219 (15.98%)
         occurrences all number
    14
    19
    36
    Dry skin
         subjects affected / exposed
    6 / 114 (5.26%)
    14 / 200 (7.00%)
    17 / 219 (7.76%)
         occurrences all number
    7
    14
    17
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    18 / 114 (15.79%)
    34 / 200 (17.00%)
    37 / 219 (16.89%)
         occurrences all number
    18
    36
    38
    Irritability
         subjects affected / exposed
    5 / 114 (4.39%)
    27 / 200 (13.50%)
    38 / 219 (17.35%)
         occurrences all number
    5
    28
    38
    Depression
         subjects affected / exposed
    7 / 114 (6.14%)
    21 / 200 (10.50%)
    14 / 219 (6.39%)
         occurrences all number
    7
    22
    14
    Anxiety
         subjects affected / exposed
    6 / 114 (5.26%)
    11 / 200 (5.50%)
    14 / 219 (6.39%)
         occurrences all number
    6
    11
    14
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    13 / 114 (11.40%)
    21 / 200 (10.50%)
    37 / 219 (16.89%)
         occurrences all number
    13
    24
    40
    Myalgia
         subjects affected / exposed
    8 / 114 (7.02%)
    9 / 200 (4.50%)
    45 / 219 (20.55%)
         occurrences all number
    8
    10
    47
    Muscle spasms
         subjects affected / exposed
    7 / 114 (6.14%)
    17 / 200 (8.50%)
    11 / 219 (5.02%)
         occurrences all number
    9
    18
    11
    Back pain
         subjects affected / exposed
    9 / 114 (7.89%)
    11 / 200 (5.50%)
    13 / 219 (5.94%)
         occurrences all number
    10
    11
    15
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 114 (7.89%)
    22 / 200 (11.00%)
    4 / 219 (1.83%)
         occurrences all number
    10
    25
    5
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 114 (6.14%)
    9 / 200 (4.50%)
    2 / 219 (0.91%)
         occurrences all number
    7
    9
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    3 / 114 (2.63%)
    8 / 200 (4.00%)
    32 / 219 (14.61%)
         occurrences all number
    3
    8
    34

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Feb 2013
    Incorporated 2 additional treatment groups: (1) SOF+RBV for a duration of 24 weeks for subjects with genotype 2 or 3 HCV infection and (2) SOF+Peg-IFN+RBV for a duration of 12 weeks for subjects with any genotype of HCV infection.
    10 May 2013
    Provided rationale and guidance for genotype for each treatment group, updated exclusion criteria to be in agreement with Peg-IFN contraindications, and added guidelines for toxicity management of Peg-IFN.

    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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