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   43857   clinical trials with a EudraCT protocol, of which   7284   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 II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) with and without Ribavirin (RBV) in Cirrhotic Subjects with Chronic HCV GT3 Infection

    Summary
    EudraCT number
    		 2015-003187-37
    Trial protocol
    		 GB  
    Global end of trial date
    06 Jan 2017

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    5172-083
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02332707
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    06 Jan 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a randomized, multi-site, open-label trial of the co-administration of a fixed-dose combination (FDC) of EBR 50 mg + GZR (100 mg) (EBR/GZR) and SOF 400 mg, with and without RBV, in treatment-naïve (TN) and treatment-experienced (TE) participants with chronic hepatitis C virus (HCV) genotype 3 (GT3) infection with compensated cirrhosis.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jan 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 100
    Worldwide total number of subjects
    100
    EEA total number of subjects
    100
    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)
    91
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Adult participants infected with HCV GT3 were enrolled at 14 study centers in the United Kingdom.

    Pre-assignment
    Screening details
    		 A total of 101 participants were randomized, including 1 participant who did not meet inclusion criteria and who should have been considered a screen failure; this participant was not treated with study drug. A total of 100 participants were treated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
    Arm description
    		 Treatment-naïve (TN) Hepatitis C virus (HCV) genotype 3 (GT3) participants took 1 fixed-dose combination (FDC) tablet containing elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg and 1 tablet containing sofosbuvir (SOF) 400 mg once daily (q.d.) with ribavirin (RBV) (200 mg capsules; weight-based dosing) twice daily (b.i.d.) for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Grazoprevir
    Investigational medicinal product code
    Other name
    MK-5172
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken once daily (q.d.) by mouth in the morning.

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose ranging from 800 mg to 1400 mg (total daily dose was based on participant body weight).

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SOF 400 mg tablet taken q.d. by mouth in the morning with food.

    Arm title
    		 Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
    Arm description
    		 TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Grazoprevir
    Investigational medicinal product code
    Other name
    MK-5172
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken once daily (q.d.) by mouth in the morning.

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SOF 400 mg tablet taken q.d. by mouth in the morning with food.

    Arm title
    		 Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
    Arm description
    		 Treatment-experienced (TE) HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Grazoprevir
    Investigational medicinal product code
    Other name
    MK-5172
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken once daily (q.d.) by mouth in the morning.

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SOF 400 mg tablet taken q.d. by mouth in the morning with food.

    Arm title
    		 Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
    Arm description
    		 TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Grazoprevir
    Investigational medicinal product code
    Other name
    MK-5172
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken once daily (q.d.) by mouth in the morning.

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose ranging from 800 mg to 1400 mg (total daily dose was based on participant body weight).

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SOF 400 mg tablet taken q.d. by mouth in the morning with food.

    Arm title
    		 Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
    Arm description
    		 TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Grazoprevir
    Investigational medicinal product code
    Other name
    MK-5172
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken once daily (q.d.) by mouth in the morning.

    Investigational medicinal product name
    Sofosbuvir
    Investigational medicinal product code
    Other name
    Sovaldi®, Harvoni®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    SOF 400 mg tablet taken q.d. by mouth in the morning with food.

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.

    Number of subjects in period 1
    		Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
    Started
    23
    24
    17
    18
    18
    Completed
    23
    20
    16
    17
    16
    Not completed
    0
    4
    1
    1
    2
         Consent withdrawn by subject
    -
    1
    -
    1
    -
         Lost to follow-up
    -
    3
    1
    -
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
    Reporting group description
    		 Treatment-naïve (TN) Hepatitis C virus (HCV) genotype 3 (GT3) participants took 1 fixed-dose combination (FDC) tablet containing elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg and 1 tablet containing sofosbuvir (SOF) 400 mg once daily (q.d.) with ribavirin (RBV) (200 mg capsules; weight-based dosing) twice daily (b.i.d.) for 8 weeks.

    Reporting group title
    Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
    Reporting group description
    		 TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.

    Reporting group title
    Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
    Reporting group description
    		 Treatment-experienced (TE) HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.

    Reporting group title
    Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
    Reporting group description
    		 TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.

    Reporting group title
    Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
    Reporting group description
    		 TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.

    Reporting group values
    		 Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks Total
    Number of subjects
    		 23 24 17 18 18 100
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 21 24 14 15 17 91
        From 65-84 years
    		 2 0 3 3 1 9
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 52.5 ± 9.0 48.1 ± 9.3 58.6 ± 6.1 56.1 ± 8.4 53.8 ± 6.4 -
    Gender, Male/Female
    Units: Subjects
        Female
    		 10 7 6 6 3 32
        Male
    		 13 17 11 12 15 68

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks
    Reporting group description
    		 Treatment-naïve (TN) Hepatitis C virus (HCV) genotype 3 (GT3) participants took 1 fixed-dose combination (FDC) tablet containing elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg and 1 tablet containing sofosbuvir (SOF) 400 mg once daily (q.d.) with ribavirin (RBV) (200 mg capsules; weight-based dosing) twice daily (b.i.d.) for 8 weeks.

    Reporting group title
    Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks
    Reporting group description
    		 TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.

    Reporting group title
    Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks
    Reporting group description
    		 Treatment-experienced (TE) HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.

    Reporting group title
    Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks
    Reporting group description
    		 TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.

    Reporting group title
    Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
    Reporting group description
    		 TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.

    Primary: Percentage of participants achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy)

    		 Close Top of page
    End point title
    		 Percentage of participants achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy) [1]
    End point description
    The percentage of participants achieving SVR12 (i.e., HCV ribnonucleic acid [RNA] < Lower Limit of Quantification [LLOQ] 12 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. All randomized participants who received at least 1 dose of study drug, were not lost to follow-up for reasons unrelated to study treatment, and had SVR12 data available are included.
    End point type
    Primary
    End point timeframe
    Up to Week 28
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
    Number of subjects analysed
    23
    23
    17
    17
    18
    Units: Percentage of Participants
        number (confidence interval 95%)
    91.3 (72.0 to 98.9)
    100.0 (85.2 to 100.0)
    100.0 (80.5 to 100.0)
    100.0 (80.5 to 100.0)
    94.4 (72.7 to 99.9)
    No statistical analyses for this end point

    Primary: Percentage of participants experiencing an adverse event (AE)

    		 Close Top of page
    End point title
    		 Percentage of participants experiencing an adverse event (AE) [2]
    End point description
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All participants who received at least 1 dose of study drug are included.
    End point type
    Primary
    End point timeframe
    Up to 18 weeks (up to 2 weeks after completion of study treatment)
    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: Per protocol, only descriptive statistics are presented.
    End point values
    		 Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
    Number of subjects analysed
    23
    24
    17
    18
    18
    Units: Percentage of Participants
        number (not applicable)
    87.0
    87.5
    82.4
    94.4
    94.4
    No statistical analyses for this end point

    Primary: Percentage of participants discontinuing from study therapy due to an AE

    		 Close Top of page
    End point title
    		 Percentage of participants discontinuing from study therapy due to an AE [3]
    End point description
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. All participants who received at least 1 dose of study drug are included.
    End point type
    Primary
    End point timeframe
    Up to 16 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: Per protocol, only descriptive statistics are presented.
    End point values
    		 Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
    Number of subjects analysed
    23
    24
    17
    18
    18
    Units: Percentage of Participants
        number (not applicable)
    0.0
    0.0
    0.0
    0.0
    5.6
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy)

    		 Close Top of page
    End point title
    		 Percentage of participants achieving SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy)
    End point description
    The percentage of participants achieving SVR24 (i.e., HCV RNA < LLOQ 24 weeks after completing study treatment) was determined. Plasma HCV RNA levels were determined with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay, which has a LLOQ of 15 IU/mL. All randomized participants who received at least 1 dose of study drug, were not lost to follow-up for reasons unrelated to study treatment, and had SVR24 data available are included.
    End point type
    Secondary
    End point timeframe
    Up to Week 40
    End point values
    		 Arm 1: HCV GT3 TN EBG/GZR+SOF+RBV 8 Weeks Arm 2: HCV GT3 TN EBG/GZR+SOF 12 Weeks Arm 3: HCV GT3 TE EBG/GZR+SOF 12 Weeks Arm 4: HCV GT3 TE EBG/GZR+SOF+RBV 12 Weeks Arm 5: HCV GT3 TE EBG/GZR+SOF 16 Weeks
    Number of subjects analysed
    23
    21
    16
    17
    16
    Units: Percentage of Participants
        number (confidence interval 95%)
    91.3 (72.0 to 98.9)
    100.0 (83.9 to 100.0)
    100.0 (79.4 to 100.0)
    100.0 (80.5 to 100.0)
    93.8 (69.8 to 99.8)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Up to 40 weeks
    Adverse event reporting additional description
    All participants who received at least 1 dose of study drug are included.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Arm 2: HCV GT3 TN EBR/GZR+SOF 12 weeks
    Reporting group description
    		 TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.

    Reporting group title
    Arm 1: HCV GT3 TN EBR/GZR+SOF+RBV 8 Weeks
    Reporting group description
    		 TN HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 8 weeks.

    Reporting group title
    Arm 4: HCV GT3 TE EBR/GZR+SOF+RBV 12 weeks
    Reporting group description
    		 TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. with RBV (200 mg capsules; weight-based dosing) b.i.d. for 12 weeks.

    Reporting group title
    Arm 5: HCV GT3 TE EBR/GZR+SOF 16 weeks
    Reporting group description
    		 TE HCV GT3 participants took 1 FDC tablet containing EBR 50 mg+GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 16 weeks.

    Reporting group title
    Arm 3: HCV GT3 TE EBR/GZR+SOF 12 weeks
    Reporting group description
    		 Treatment-experienced (TE) HCV GT3 participants took 1 FDC tablet containing EBR 50 mg + GZR 100 mg and 1 tablet containing SOF 400 mg q.d. for 12 weeks.

    Serious adverse events
    		 Arm 2: HCV GT3 TN EBR/GZR+SOF 12 weeks Arm 1: HCV GT3 TN EBR/GZR+SOF+RBV 8 Weeks Arm 4: HCV GT3 TE EBR/GZR+SOF+RBV 12 weeks Arm 5: HCV GT3 TE EBR/GZR+SOF 16 weeks Arm 3: HCV GT3 TE EBR/GZR+SOF 12 weeks
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    3 / 18 (16.67%)
    1 / 18 (5.56%)
    2 / 17 (11.76%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Investigations
    Creatinine renal clearance decreased
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Arm 2: HCV GT3 TN EBR/GZR+SOF 12 weeks Arm 1: HCV GT3 TN EBR/GZR+SOF+RBV 8 Weeks Arm 4: HCV GT3 TE EBR/GZR+SOF+RBV 12 weeks Arm 5: HCV GT3 TE EBR/GZR+SOF 16 weeks Arm 3: HCV GT3 TE EBR/GZR+SOF 12 weeks
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 24 (87.50%)
    21 / 23 (91.30%)
    17 / 18 (94.44%)
    17 / 18 (94.44%)
    16 / 17 (94.12%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    0
    0
    0
    1
    Peripheral coldness
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    2
    1
    0
    Fatigue
         subjects affected / exposed
    8 / 24 (33.33%)
    6 / 23 (26.09%)
    10 / 18 (55.56%)
    6 / 18 (33.33%)
    6 / 17 (35.29%)
         occurrences all number
    10
    6
    10
    6
    6
    Feeling hot
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    2 / 18 (11.11%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    2
    0
    2
    1
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    Reproductive system and breast disorders
    Nipple pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    2
    1
    1
    Dysphonia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
    3 / 18 (16.67%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    3
    0
    1
    Dyspnoea exertional
         subjects affected / exposed
    0 / 24 (0.00%)
    3 / 23 (13.04%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    Epistaxis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    2 / 17 (11.76%)
         occurrences all number
    0
    0
    1
    2
    2
    Oropharyngeal pain
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
    2 / 18 (11.11%)
    4 / 18 (22.22%)
    1 / 17 (5.88%)
         occurrences all number
    1
    1
    2
    4
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    0
    2
    0
    1
    1
    Depressed mood
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    1
    0
    Depression
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    0
    1
    0
    1
    Emotional disorder
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Euphoric mood
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hallucination
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    2
    0
    0
    1
    Irritability
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Mood swings
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    3 / 18 (16.67%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    3
    0
    0
    Panic attack
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    1
    0
    0
    2
    Investigations
    Blood potassium increased
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    3 / 18 (16.67%)
    0 / 18 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    1
    4
    0
    3
    Skin abrasion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 23 (8.70%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    2
    1
    0
    1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Disturbance in attention
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Dizziness
         subjects affected / exposed
    3 / 24 (12.50%)
    1 / 23 (4.35%)
    3 / 18 (16.67%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    3
    1
    3
    1
    0
    Dysgeusia
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    Headache
         subjects affected / exposed
    7 / 24 (29.17%)
    5 / 23 (21.74%)
    11 / 18 (61.11%)
    7 / 18 (38.89%)
    5 / 17 (29.41%)
         occurrences all number
    7
    6
    12
    7
    7
    Hypersomnia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    0
    1
    0
    0
    3
    Lethargy
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Memory impairment
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nystagmus
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Sinus headache
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Syncope
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tremor
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    1
    0
    1
    Hypoacusis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    0
    1
    Lacrimation increased
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Myopia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Visual impairment
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Abdominal distension
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    3 / 17 (17.65%)
         occurrences all number
    0
    0
    2
    0
    3
    Abdominal pain
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 23 (0.00%)
    4 / 18 (22.22%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    2
    0
    4
    1
    1
    Abdominal pain lower
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    0
    1
    1
    Ascites
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    3 / 24 (12.50%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    3
    1
    0
    1
    1
    Diarrhoea
         subjects affected / exposed
    3 / 24 (12.50%)
    1 / 23 (4.35%)
    2 / 18 (11.11%)
    3 / 18 (16.67%)
    3 / 17 (17.65%)
         occurrences all number
    4
    1
    2
    3
    3
    Dry mouth
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    1
    Dyspepsia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    1
    0
    1
    1
    1
    Flatulence
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Lip dry
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Mouth ulceration
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    2
    Nausea
         subjects affected / exposed
    3 / 24 (12.50%)
    4 / 23 (17.39%)
    6 / 18 (33.33%)
    3 / 18 (16.67%)
    3 / 17 (17.65%)
         occurrences all number
    3
    4
    7
    3
    3
    Oesophagitis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Toothache
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    Vomiting
         subjects affected / exposed
    3 / 24 (12.50%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    3
    0
    1
    1
    1
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Jaundice
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    2 / 18 (11.11%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    2
    0
    1
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 24 (4.17%)
    2 / 23 (8.70%)
    4 / 18 (22.22%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    1
    2
    4
    1
    1
    Eczema
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    5 / 18 (27.78%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    1
    0
    6
    1
    1
    Rash
         subjects affected / exposed
    1 / 24 (4.17%)
    3 / 23 (13.04%)
    3 / 18 (16.67%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    1
    3
    3
    1
    2
    Skin irritation
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    3 / 18 (16.67%)
    2 / 18 (11.11%)
    2 / 17 (11.76%)
         occurrences all number
    0
    1
    3
    2
    3
    Back pain
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    1
    0
    1
    Bone pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Costochondritis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1
    Haemarthrosis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Joint effusion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    0
    1
    0
    1
    Myalgia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 23 (0.00%)
    2 / 18 (11.11%)
    1 / 18 (5.56%)
    4 / 17 (23.53%)
         occurrences all number
    2
    0
    2
    1
    5
    Neck pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 23 (8.70%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    4 / 17 (23.53%)
         occurrences all number
    0
    2
    0
    1
    4
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 23 (4.35%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    0
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 24 (8.33%)
    1 / 23 (4.35%)
    1 / 18 (5.56%)
    2 / 18 (11.11%)
    1 / 17 (5.88%)
         occurrences all number
    2
    1
    1
    2
    1
    Rhinitis
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    1 / 18 (5.56%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 24 (16.67%)
    0 / 23 (0.00%)
    1 / 18 (5.56%)
    1 / 18 (5.56%)
    0 / 17 (0.00%)
         occurrences all number
    4
    0
    1
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 23 (0.00%)
    0 / 18 (0.00%)
    0 / 18 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Dec 2015
    Amendment 01: The primary purposes of this amendment were to change the duration of contraception use and egg/sperm donation, to add criteria for discontinuation of RBV use, and to specify that SOF must be taken with food.
    09 Aug 2016
    Amendment 02: The primary purpose of this amendment was to update eligibility criteria for entry into the long-term follow-up (MK-5172-017) for participants who failed therapy in this study.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 15:22:37 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA