Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naive Subjects with Chronic HCV Infection

    Summary
    EudraCT number
    		 2015-003460-36
    Trial protocol
    		 DE   GB   FR  
    Global end of trial date
    11 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Dec 2017
    First version publication date
    16 Dec 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-367-1172
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02607800
    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 Trials Mailbox, Gilead Sciences International Ltd., ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trials 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
    11 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of this study were to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic 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
    16 Nov 2015
    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: 47
    Country: Number of subjects enrolled
    France: 187
    Country: Number of subjects enrolled
    Germany: 45
    Country: Number of subjects enrolled
    New Zealand: 26
    Country: Number of subjects enrolled
    Canada: 60
    Country: Number of subjects enrolled
    Australia: 24
    Country: Number of subjects enrolled
    United States: 554
    Worldwide total number of subjects
    943
    EEA total number of subjects
    279
    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)
    849
    From 65 to 84 years
    94
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 16 November 2015. The last study visit occurred on 11 January 2017.

    Pre-assignment
    Screening details
    		 1116 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/VOX 8 Weeks
    Arm description
    		 SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/Velpatasvir/Voxilaprevir
    Investigational medicinal product code
    Other name
    Vosevi®, SOF/VEL/VOX
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400/100/100 mg once daily with food for 8 weeks

    Arm title
    		 SOF/VEL 12 Weeks
    Arm description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Sofosbuvir/Velpatasvir
    Investigational medicinal product code
    Other name
    Epclusa®; SOF/VEL
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400/100 mg FDC once daily with or without food for 12 weeks

    Number of subjects in period 1 [1]
    		SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Started
    501
    440
    Completed
    492
    430
    Not completed
    9
    10
         Withdrew Consent
    2
    -
         Lost to follow-up
    7
    10
    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: 2 participants (one in each treatment group) who were randomized but not treated are not included in the subject disposition table.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    SOF/VEL/VOX 8 Weeks
    Reporting group description
    		 SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks

    Reporting group title
    SOF/VEL 12 Weeks
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks

    Reporting group values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks Total
    Number of subjects
    		 501 440 941
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 53 ( 11.1 ) 52 ( 11.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 246 203 449
        Male
    		 255 237 492
    Race
    Units: Subjects
        White
    		 391 365 756
        Black or African American
    		 48 47 95
        Asian
    		 51 22 73
        Other
    		 5 2 7
        American Indian or Alaska Native
    		 3 2 5
        Native Hawaiian or Pacific Islander
    		 3 2 5
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 32 52 84
        Not Hispanic or Latino
    		 469 388 857
    IL28b Status
    The CC, CT, and TT alleles are different forms of the IL28b gene.
    Units: Subjects
        CC
    		 166 136 302
        CT
    		 253 245 498
        TT
    		 82 59 141
    HCV RNA Category
    Units: Subjects
        < 800,000 IU/mL
    		 155 138 293
        ≥ 800,000 IU/mL
    		 346 302 648
    HCV RNA
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    		 6.1 ( 0.75 ) 6.2 ( 0.66 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    SOF/VEL/VOX 8 Weeks
    Reporting group description
    		 SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks

    Reporting group title
    SOF/VEL 12 Weeks
    Reporting group description
    		 SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks

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

    		 Close Top of page
    End point title
    		 Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
    End point description
    1) SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. 2) Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of the study drug
    End point type
    Primary
    End point timeframe
    Posttreatment Week 12
    End point values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    501
    440
    Units: percentage of participants
        number (confidence interval 95%)
    95.2 (93.0 to 96.9)
    98.2 (96.4 to 99.2)
    Statistical analysis title
    		 SVR12 – SOF/VEL/VOX 8 Weeks vs SOF/VEL 12 Weeks
    Comparison groups
    SOF/VEL 12 Weeks v SOF/VEL/VOX 8 Weeks
    Number of subjects included in analysis
    941
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in proportions
    Point estimate
    -3.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6
         upper limit
    		 -0.4
    Notes
    [1] - Noninferiority was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 was greater than −5%. If the lower bound of the CI was greater than −5% (ie, the noninferiority null hypothesis was rejected), a 2-sided stratified Cochran-Mantel-Haenszel test was to be used to test for the superiority of SOF/VEL/VOX for 8 weeks over SOF/VEL for 12 weeks at a significance level of 0.05.

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

    		 Close Top of page
    End point title
    		 Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event [2]
    End point description
    Safety Analysis Set
    End point type
    Primary
    End point timeframe
    Up to 12 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/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    501
    440
    Units: percentage of participants
        number (not applicable)
    0
    0.5
    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)

    		 Close Top of page
    End point title
    		 Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
    End point description
    1) SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. 2) Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    501
    440
    Units: percentage of participants
    number (confidence interval 95%)
        SVR4
    96.4 (94.4 to 97.9)
    98.9 (97.4 to 99.6)
        SVR24
    95.0 (92.7 to 96.7)
    98.0 (96.2 to 99.1)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HCV RNA < LLOQ On Treatment

    		 Close Top of page
    End point title
    		 Percentage of Participants With HCV RNA < LLOQ On Treatment
    End point description
    1) Percentage of participants in Full Analysis Set with on-treatment data were analyzed. 2) 999 = Not Applicable (NA) (The treatment for this group was only 8 weeks.)
    End point type
    Secondary
    End point timeframe
    Posttreatment Weeks 4 and 24
    End point values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    501
    440
    Units: percentage of participants
    number (confidence interval 95%)
        Week 1 (SOF/VEL/VOX: N = 501; SOF/VEL: N= 440)
    24.8 (21.0 to 28.8)
    22.7 (18.9 to 26.9)
        Week 2 (SOF/VEL/VOX: N = 501; SOF/VEL: N= 439)
    65.9 (61.5 to 70.0)
    61.3 (56.5 to 65.9)
        Week 4 (SOF/VEL/VOX: N = 501; SOF/VEL:N= 439)
    92.4 (89.7 to 94.6)
    92.0 (89.1 to 94.4)
        Week 8 (SOF/VEL/VOX: N = 500; SOF/VEL: N= 439)
    99.2 (98.0 to 99.8)
    99.8 (98.7 to 100.0)
        Week 12 (SOF/VEL/VOX: N =NA; SOF/VEL: N= 439)
    999 (999 to 999)
    99.8 (98.7 to 100.0)
    No statistical analyses for this end point

    Secondary: Change From Baseline in HCV RNA

    		 Close Top of page
    End point title
    		 Change From Baseline in HCV RNA
    End point description
    1) Participants in the Full Analysis Set with available data were analyzed. 2) 999 = Not Applicable (NA) (The treatment for this group was only 8 weeks.)
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks
    End point values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    501
    440
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 1 (SOF/VEL/VOX: N = 491; SOF/VEL: N= 433)
    -4.23 ( 0.689 )
    -4.24 ( 0.679 )
        Week 2 (SOF/VEL/VOX: N = 496; SOF/VEL: N= 436)
    -4.75 ( 0.747 )
    -4.77 ( 0.646 )
        Week 4 (SOF/VEL/VOX: N = 501; SOF/VEL: N= 437)
    -4.95 ( 0.75 )
    -4.99 ( 0.656 )
        Week 8 (SOF/VEL/VOX: N = 496; SOF/VEL: N= 439)
    -4.99 ( 0.754 )
    -5.03 ( 0.655 )
        Week 12 (SOF/VEL/VOX: N = NA; SOF/VEL: N= 438)
    999 ( 999 )
    -5.03 ( 0.656 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Virologic Failure

    		 Close Top of page
    End point title
    		 Percentage of Participants With Virologic Failure
    End point description
    Virologic failure is defined as: 1) On-treatment virologic failure: a) Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or b) Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or c) Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) 2) Virologic relapse: a) Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit
    End point type
    Secondary
    End point timeframe
    Up to Posttreatment Week 24
    End point values
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Number of subjects analysed
    501
    440
    Units: percentage of participants
        number (not applicable)
    4.2
    0.7
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 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
    19.0
    Reporting groups
    Reporting group title
    SOF/VEL/VOX 8 Weeks
    Reporting group description
    		 SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks

    Reporting group title
    SOF/VEL 12 Weeks
    Reporting group description
    		 SOF/VEL ( 400/100 mg) FDC tablet orally once daily with or without food for 12 weeks

    Serious adverse events
    		 SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 501 (2.99%)
    7 / 440 (1.59%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma metastatic
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (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
    Asthma
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 501 (0.00%)
    1 / 440 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 501 (0.00%)
    1 / 440 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 501 (0.00%)
    1 / 440 (0.23%)
         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
    Multiple fractures
         subjects affected / exposed
    0 / 501 (0.00%)
    1 / 440 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 501 (0.00%)
    1 / 440 (0.23%)
         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 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    0 / 501 (0.00%)
    1 / 440 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (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
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    0 / 501 (0.00%)
    1 / 440 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 501 (0.00%)
    1 / 440 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    1 / 501 (0.20%)
    0 / 440 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 501 (0.00%)
    1 / 440 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 501 (0.20%)
    1 / 440 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Myositis
         subjects affected / exposed
    0 / 501 (0.00%)
    1 / 440 (0.23%)
         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/VOX 8 Weeks SOF/VEL 12 Weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    280 / 501 (55.89%)
    213 / 440 (48.41%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    134 / 501 (26.75%)
    99 / 440 (22.50%)
         occurrences all number
    150
    112
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    32 / 501 (6.39%)
    27 / 440 (6.14%)
         occurrences all number
    35
    27
    Fatigue
         subjects affected / exposed
    106 / 501 (21.16%)
    91 / 440 (20.68%)
         occurrences all number
    114
    93
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    88 / 501 (17.56%)
    32 / 440 (7.27%)
         occurrences all number
    98
    36
    Nausea
         subjects affected / exposed
    80 / 501 (15.97%)
    40 / 440 (9.09%)
         occurrences all number
    83
    45
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    26 / 501 (5.19%)
    21 / 440 (4.77%)
         occurrences all number
    28
    21
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    19 / 501 (3.79%)
    24 / 440 (5.45%)
         occurrences all number
    19
    25

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Oct 2015
    1. Removed all references to genotype 3 cirrhotic subjects and clarified that these subjects will not be enrolled in this study, but rather will be included in GS-US-367-1173 2. The total number of study centers participating were increased from 100 to 120. 3. Revisions were made to the approximate number of subjects by genotype to be randomized or enrolled into each group. 4. Updates were made to Rationale for This Study, Rationale for the Study Design, and Risk/Benefit Assessment for the Study to account for study changes and provide clarification. 5. Additional formatting, minor grammatical corrections, and updates were made.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28390869
    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.

    European Medicines Agency © 1995-Fri May 09 18:05:17 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA