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    Clinical Trial Results:
    A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks with Sofosbuvir and Ribavirin for 24 Weeks in Subjects with Chronic Genotype 3 HCV Infection

    Summary
    EudraCT number
    		 2014-001682-27
    Trial protocol
    		 GB   IT   FR  
    Global end of trial date
    15 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Nov 2016
    First version publication date
    11 Nov 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-342-1140
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02201953
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trial Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis C virus (HCV) infection.
    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
    25 Jun 2014
    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
    United Kingdom: 108
    Country: Number of subjects enrolled
    France: 102
    Country: Number of subjects enrolled
    Germany: 66
    Country: Number of subjects enrolled
    Italy: 18
    Country: Number of subjects enrolled
    New Zealand: 17
    Country: Number of subjects enrolled
    Canada: 33
    Country: Number of subjects enrolled
    United States: 121
    Country: Number of subjects enrolled
    Australia: 93
    Worldwide total number of subjects
    558
    EEA total number of subjects
    294
    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)
    537
    From 65 to 84 years
    21
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Australia, North America, Europe, and New Zealand. The first participant was screened on 14 July 2014. The last study visit occurred on 15 December 2015.

    Pre-assignment
    Screening details
    		 652 participants were screened.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SOF/VEL 12 Weeks
    Arm description
    		 SOF/VEL for 12 weeks
    Arm type
    		 Experimental

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

    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
    400 mg administered 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
    Administered 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 [1]
    		SOF/VEL 12 Weeks SOF+RBV 24 Weeks
    Started
    277
    275
    Completed
    258
    224
    Not completed
    19
    51
         Adverse event, serious fatal
    -
    2
         Withdrew Consent
    2
    5
         Adverse event, non-fatal
    -
    5
         Death
    -
    1
         Lost to follow-up
    8
    8
         Lack of efficacy
    9
    30
    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: 6 participants (SOF/VEL 12 Weeks = 1; SOF+RBV 24 Weeks = 5) who were randomized but not treated are not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SOF/VEL 12 Weeks
    Reporting group description
    		 SOF/VEL for 12 weeks

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

    Reporting group values
    		 SOF/VEL 12 Weeks SOF+RBV 24 Weeks Total
    Number of subjects
    		 277 275 552
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49 ± 10.4 50 ± 10 -
    Gender categorical
    Units: Subjects
        Female
    		 107 101 208
        Male
    		 170 174 344
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 11 11 22
        Not Hispanic or Latino
    		 266 263 529
        Not Disclosed
    		 0 1 1
    Race
    Units: Subjects
        Black or African American
    		 3 1 4
        White
    		 250 239 489
        Asian
    		 23 29 52
        American Indian or Alaska Native
    		 1 3 4
        Native Hawaiian or Pacific Islander
    		 0 2 2
        Not Disclosed
    		 0 1 1
    HCV Genotype
    Units: Subjects
        Genotype 3 (No Confirmed Subtype)
    		 9 18 27
        Genotype 3a
    		 265 250 515
        Genotype 3b
    		 2 5 7
        Genotype 3h
    		 0 2 2
        Genotype 3k
    		 1 0 1
    Cirrhosis Status
    Units: Subjects
        Yes
    		 80 83 163
        No
    		 197 187 384
        Missing
    		 0 5 5
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 105 111 216
        CT
    		 148 133 281
        TT
    		 24 31 55
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 86 81 167
        ≥ 800,000 IU/mL
    		 191 194 385
    Prior HCV Treatment Experience
    Units: Subjects
        Treatment-Naive
    		 206 204 410
        Treatment-Experienced
    		 71 71 142
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.2 ± 0.72 6.3 ± 0.71 -

    End points

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    End points reporting groups
    Reporting group title
    SOF/VEL 12 Weeks
    Reporting group description
    		 SOF/VEL for 12 weeks

    Reporting group title
    SOF+RBV 24 Weeks
    Reporting group description
    		 SOF+RBV for 24 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)
    End point description
    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Posttreatment Week 12
    End point values
    		 SOF/VEL 12 Weeks SOF+RBV 24 Weeks
    Number of subjects analysed
    277
    275
    Units: percentage of participants
        number (confidence interval 95%)
    95.3 (92.1 to 97.5)
    80.7 (75.6 to 85.2)
    Statistical analysis title
    		 Non-Inferiority Analysis - SVR12
    Statistical analysis description
    Primary analyses consisted of non-inferiority test of Group 1 (SOF/VEL 12 weeks) versus Group 2 (SOF+RBV 24 weeks) at the 0.05 significance level. Non-inferiority was assessed using the conventional confidence interval approach and a non-inferiority margin of 10% was applied. The two-sided 95% confidence intervals was constructed using stratum-adjusted Mantel-Haenszel proportions, stratified by the randomization stratification factors (i.e cirrhosis status and prior treatment experience)
    Comparison groups
    SOF/VEL 12 Weeks v SOF+RBV 24 Weeks
    Number of subjects included in analysis
    552
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    14.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.2
         upper limit
    		 19.6
    Notes
    [1] - Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.
    Statistical analysis title
    		 Superiority Analysis - SVR12
    Statistical analysis description
    If the lower bound of 95% CI on the difference was > -10%, the p-value tested for the superiority of SOF/VEL for 12 weeks over SOF+RBV for 24 weeks. Superiority was demonstrated if the two-sided p-value is less than 0.05.
    Comparison groups
    SOF/VEL 12 Weeks v SOF+RBV 24 Weeks
    Number of subjects included in analysis
    552
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - P-value was from the Cochran-Mantel-Haenszel test stratified by cirrhosis status and prior HCV treatment experience.

    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 [3]
    End point description
    Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 24 weeks
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 SOF/VEL 12 Weeks SOF+RBV 24 Weeks
    Number of subjects analysed
    277
    275
    Units: percentage of participants
        number (not applicable)
    0
    3.3
    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 SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug. Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 SOF/VEL 12 Weeks SOF+RBV 24 Weeks
    Number of subjects analysed
    277
    275
    Units: percentage of participants
    number (confidence interval 95%)
        SVR4
    96.8 (93.9 to 98.5)
    82.2 (77.1 to 86.5)
        SVR24
    95.3 (92.1 to 97.5)
    80.7 (75.6 to 85.2)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

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    End point title
    		 Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
    End point values
    		 SOF/VEL 12 Weeks SOF+RBV 24 Weeks
    Number of subjects analysed
    277 [4]
    275
    Units: percentage of participants
    number (confidence interval 95%)
        Week 1 (SOF/VEL: N = 277; SOF+RBV: N = 275)
    18.4 (14 to 23.5)
    17.5 (13.2 to 22.5)
        Week 2 (SOF/VEL: N = 276; SOF+RBV: N = 274)
    62 (55.9 to 67.7)
    50 (43.9 to 56.1)
        Week 4 (SOF/VEL: N = 276; SOF+RBV: N = 272)
    91.7 (87.8 to 94.6)
    88.2 (83.8 to 91.8)
        Week 6 (SOF/VEL: N = 276; SOF+RBV: N = 269)
    96.7 (93.9 to 98.5)
    98.9 (96.8 to 99.8)
        Week 8 (SOF/VEL: N = 276; SOF+RBV: N = 269)
    99.6 (98 to 100)
    99.3 (97.3 to 99.9)
        Week 10 (SOF/VEL: N = 276; SOF+RBV: N = 268)
    100 (98.7 to 100)
    99.3 (97.3 to 99.9)
        Week 12 (SOF/VEL: N = 275; SOF+RBV: N = 265)
    100 (98.7 to 100)
    99.6 (97.9 to 100)
        Week 16 (SOF/VEL: N = 0; SOF+RBV: N = 262)
    9999 (9999 to 9999)
    98.9 (96.7 to 99.8)
        Week 20 (SOF/VEL: N = 0; SOF+RBV: N = 260)
    9999 (9999 to 9999)
    99.6 (97.9 to 100)
        Week 24 (SOF/VEL: N = 0; SOF+RBV: N = 255)
    9999 (9999 to 9999)
    100 (98.6 to 100)
    Notes
    [4] - 9999 = Not applicable; Participants in the SOF/VEL group were only treated for 12 weeks.
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

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    End point title
    		 Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
    End point description
    Participants in the Full Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
    End point values
    		 SOF/VEL 12 Weeks SOF+RBV 24 Weeks
    Number of subjects analysed
    277 [5]
    275
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Change at Wk 1 (SOF/VEL: N =272; SOF+RBV: N =268)
    -4.26 ± 0.644
    -4.16 ± 0.64
        Change at Wk 2 (SOF/VEL: N =274; SOF+RBV: N =272)
    -4.82 ± 0.769
    -4.79 ± 0.702
        Change at Wk 4 (SOF/VEL: N =276; SOF+RBV: N =270)
    -5.02 ± 0.776
    -5.09 ± 0.699
        Change at Wk 6 (SOF/VEL: N =275; SOF+RBV: N =269)
    -5.06 ± 0.718
    -5.13 ± 0.712
        Change at Wk 8 (SOF/VEL: N =276; SOF+RBV: N =269)
    -5.07 ± 0.728
    -5.13 ± 0.712
        Change at Wk 10 (SOF/VEL: N =276; SOF+RBV: N =267)
    -5.07 ± 0.723
    -5.14 ± 0.71
        Change at Wk 12 (SOF/VEL: N =275; SOF+RBV: N =264)
    -5.08 ± 0.721
    -5.14 ± 0.711
        Change at Wk 16 (SOF/VEL: N = 0; SOF+RBV: N = 262)
    9999 ± 9999
    -5.11 ± 0.765
        Change at Wk 20 (SOF/VEL: N = 0; SOF+RBV: N = 259)
    9999 ± 9999
    -5.14 ± 0.715
        Change at Wk 24 (SOF/VEL: N = 0; SOF+RBV: N = 255)
    9999 ± 9999
    -5.14 ± 0.715
    Notes
    [5] - 9999 = Not applicable; Participants in the SOF/VEL group were only treated for 12 weeks.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virologic Failure

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    End point title
    		 Percentage of Participants With Virologic Failure
    End point description
    Virologic failure was defined as: • On-treatment virologic failure: •• Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or •• Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or •• Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) • Virologic relapse: •• Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last ontreatment visit. Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 24
    End point values
    		 SOF/VEL 12 Weeks SOF+RBV 24 Weeks
    Number of subjects analysed
    277
    275
    Units: percentage of participants
        number (not applicable)
    4
    14.2
    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
    18.0
    Reporting groups
    Reporting group title
    SOF/VEL 12 Weeks
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks

    Reporting group title
    SOF+RBV 24 Weeks
    Reporting group description
    		 SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks

    Serious adverse events
    		 SOF/VEL 12 Weeks SOF+RBV 24 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 277 (2.17%)
    15 / 275 (5.45%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Ovarian cyst ruptured
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Forearm fracture
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intentional overdose
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 277 (0.36%)
    0 / 275 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Propionibacterium infection
         subjects affected / exposed
    0 / 277 (0.00%)
    1 / 275 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SOF/VEL 12 Weeks SOF+RBV 24 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    216 / 277 (77.98%)
    243 / 275 (88.36%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    90 / 277 (32.49%)
    90 / 275 (32.73%)
         occurrences all number
    111
    114
    Dizziness
         subjects affected / exposed
    15 / 277 (5.42%)
    21 / 275 (7.64%)
         occurrences all number
    15
    23
    Disturbance in attention
         subjects affected / exposed
    7 / 277 (2.53%)
    14 / 275 (5.09%)
         occurrences all number
    7
    14
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 277 (0.36%)
    25 / 275 (9.09%)
         occurrences all number
    1
    25
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    71 / 277 (25.63%)
    105 / 275 (38.18%)
         occurrences all number
    73
    107
    Pyrexia
         subjects affected / exposed
    4 / 277 (1.44%)
    14 / 275 (5.09%)
         occurrences all number
    4
    15
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    47 / 277 (16.97%)
    58 / 275 (21.09%)
         occurrences all number
    49
    69
    Dyspepsia
         subjects affected / exposed
    9 / 277 (3.25%)
    30 / 275 (10.91%)
         occurrences all number
    10
    33
    Diarrhoea
         subjects affected / exposed
    20 / 277 (7.22%)
    21 / 275 (7.64%)
         occurrences all number
    21
    22
    Abdominal pain
         subjects affected / exposed
    10 / 277 (3.61%)
    19 / 275 (6.91%)
         occurrences all number
    10
    21
    Constipation
         subjects affected / exposed
    13 / 277 (4.69%)
    21 / 275 (7.64%)
         occurrences all number
    13
    21
    Vomiting
         subjects affected / exposed
    8 / 277 (2.89%)
    20 / 275 (7.27%)
         occurrences all number
    9
    26
    Asthenia
         subjects affected / exposed
    16 / 277 (5.78%)
    26 / 275 (9.45%)
         occurrences all number
    16
    28
    Reproductive system and breast disorders
    Cough
         subjects affected / exposed
    14 / 277 (5.05%)
    35 / 275 (12.73%)
         occurrences all number
    15
    39
    Dyspnoea exertional
         subjects affected / exposed
    3 / 277 (1.08%)
    20 / 275 (7.27%)
         occurrences all number
    3
    20
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    8 / 277 (2.89%)
    22 / 275 (8.00%)
         occurrences all number
    9
    22
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    8 / 277 (2.89%)
    35 / 275 (12.73%)
         occurrences all number
    8
    36
    Rash
         subjects affected / exposed
    15 / 277 (5.42%)
    14 / 275 (5.09%)
         occurrences all number
    15
    18
    Dry skin
         subjects affected / exposed
    2 / 277 (0.72%)
    25 / 275 (9.09%)
         occurrences all number
    2
    25
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    32 / 277 (11.55%)
    74 / 275 (26.91%)
         occurrences all number
    32
    81
    Irritability
         subjects affected / exposed
    23 / 277 (8.30%)
    40 / 275 (14.55%)
         occurrences all number
    23
    41
    Anxiety
         subjects affected / exposed
    7 / 277 (2.53%)
    21 / 275 (7.64%)
         occurrences all number
    8
    21
    Sleep disorder
         subjects affected / exposed
    9 / 277 (3.25%)
    15 / 275 (5.45%)
         occurrences all number
    9
    18
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    25 / 277 (9.03%)
    20 / 275 (7.27%)
         occurrences all number
    27
    22
    Arthralgia
         subjects affected / exposed
    10 / 277 (3.61%)
    22 / 275 (8.00%)
         occurrences all number
    14
    22
    Muscle spasms
         subjects affected / exposed
    13 / 277 (4.69%)
    17 / 275 (6.18%)
         occurrences all number
    15
    18
    Myalgia
         subjects affected / exposed
    10 / 277 (3.61%)
    15 / 275 (5.45%)
         occurrences all number
    10
    15
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    34 / 277 (12.27%)
    33 / 275 (12.00%)
         occurrences all number
    38
    37
    Bronchitis
         subjects affected / exposed
    6 / 277 (2.17%)
    14 / 275 (5.09%)
         occurrences all number
    6
    14
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    8 / 277 (2.89%)
    14 / 275 (5.09%)
         occurrences all number
    8
    14

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Feb 2015
    Subjects randomized to Group 2 will not be enrolled into either the SVR or the Sequence registries

    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.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26575258
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