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    Clinical Trial Results:
    A Phase II Randomized Clinical Trial to Study the Efficacy and Safety of the combination regimen of MK-5172 and MK-8742 ± Ribavirin (RBV) in Subjects with Chronic Hepatitis C Virus Infection

    Summary
    EudraCT number
    		 2012-003354-89
    Trial protocol
    		 DE   DK   HU   ES   SE   FR  
    Global end of trial date
    06 May 2015

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    5172-035
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01717326
    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 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    06 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a study of the safety and efficacy of grazoprevir (MK-5172) in combination with elbasvir (MK-8742) ± ribavirin (RBV). The primary efficacy endpoint will be Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) in each of the treatment arms.
    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
    07 Feb 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 35
    Country: Number of subjects enrolled
    Canada: 45
    Country: Number of subjects enrolled
    Denmark: 40
    Country: Number of subjects enrolled
    France: 117
    Country: Number of subjects enrolled
    Hungary: 8
    Country: Number of subjects enrolled
    Israel: 42
    Country: Number of subjects enrolled
    New Zealand: 17
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    Sweden: 15
    Country: Number of subjects enrolled
    Turkey: 11
    Country: Number of subjects enrolled
    United States: 227
    Worldwide total number of subjects
    573
    EEA total number of subjects
    196
    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)
    509
    From 65 to 84 years
    64
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Male/female participants with Hepatitis C Virus (HCV) genotype 1 (GT1) or GT3 who were either treatment-naïve (TN) or prior null responder (NR), cirrhotic (C) or noncirrhotic (NC), and monoinfected with HCV or coinfected with HCV and human immunodeficiency virus (HIV) were recruited based on entry requirements for Parts A, B, C, or D.

    Pre-assignment
    Screening details
    		 573 randomized on study: Part A=65 TN NC GT1 participants. Part B= 94 TN NC participants, 123 TN C participants, 130 NR participants (C and NC), and 59 TN HIV coinfected participants. Part C= 61 TN NC GT1b participants. Part D= 41 TN NC GT3 participants. One participant randomized to A3 arm was treated on A2 arm (n=28 for safety).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Part A: Double-blindPart B: Open-labelPart C: Open-labelPart D: Open-label

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk
    Arm description
    		 GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Arm title
    		 A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Arm description
    		 GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Arm title
    		 A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Arm description
    		 GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    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
    100 mg tablet orally QD

    Arm title
    		 B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Arm description
    		 GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Arm title
    		 B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Arm description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Arm title
    		 B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Arm description
    		 GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD 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
    100 mg tablet orally QD

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Arm title
    		 B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Arm description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Arm title
    		 B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk
    Arm description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    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
    100 mg tablet orally QD

    Arm title
    		 B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Arm description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Arm title
    		 B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
    Arm description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    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
    100 mg tablet orally QD

    Arm title
    		 B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk
    Arm description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Arm title
    		 B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Arm description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    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
    100 mg tablet orally QD

    Arm title
    		 B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Arm description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Arm title
    		 B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
    Arm description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    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
    100 mg tablet orally QD

    Arm title
    		 B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Arm description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Arm title
    		 B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Arm description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD 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
    100 mg tablet orally QD

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Arm title
    		 C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Arm description
    		 GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Arm title
    		 C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk
    Arm description
    		 GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    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
    100 mg tablet orally QD

    Arm title
    		 D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Arm description
    		 GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Arm title
    		 D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Arm description
    		 GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
    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
    100 mg tablet orally QD

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight

    Number of subjects in period 1
    		A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Started
    25
    27
    13
    30
    33
    31
    31
    29
    32
    31
    32
    33
    33
    32
    29
    30
    30
    31
    20
    21
    Completed
    22
    26
    13
    28
    31
    31
    30
    29
    32
    29
    30
    33
    32
    32
    29
    27
    29
    31
    16
    15
    Not completed
    3
    1
    0
    2
    2
    0
    1
    0
    0
    2
    2
    0
    1
    0
    0
    3
    1
    0
    4
    6
         Adverse event, serious fatal
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    -
    1
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    1
    -
    -
    1
    -
    -
    2
    3
         Physician decision
    -
    -
    -
    -
    -
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
         Lost to follow-up
    3
    -
    -
    2
    1
    -
    1
    -
    -
    -
    1
    -
    -
    -
    -
    2
    1
    -
    2
    3
         Protocol deviation
    -
    -
    -
    -
    1
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk
    Reporting group description
    		 GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.

    Reporting group title
    B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Reporting group description
    		 GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.

    Reporting group title
    B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.

    Reporting group title
    B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.

    Reporting group title
    B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.

    Reporting group title
    B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.

    Reporting group title
    B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks

    Reporting group title
    C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Reporting group description
    		 GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk
    Reporting group description
    		 GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.

    Reporting group title
    D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Reporting group description
    		 GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk Total
    Number of subjects
    		 25 27 13 30 33 31 31 29 32 31 32 33 33 32 29 30 30 31 20 21 573
    Age categorical
    Units: Subjects
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 48.7 ( 12.5 ) 43.9 ( 12.6 ) 43.3 ( 13.5 ) 48.4 ( 11.9 ) 49.7 ( 11.5 ) 53.6 ( 8.4 ) 57 ( 7 ) 59 ( 7.8 ) 58.8 ( 8.2 ) 58.9 ( 8 ) 52.2 ( 8.8 ) 54.4 ( 9.1 ) 56.2 ( 10.9 ) 54.3 ( 12.3 ) 46.2 ( 8.4 ) 43.5 ( 10.4 ) 50.6 ( 10.9 ) 55.3 ( 10.3 ) 49 ( 11.5 ) 42.4 ( 10.8 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 13 17 6 12 15 15 12 10 17 10 12 13 17 14 6 6 14 18 12 13 252
        Male
    		 12 10 7 18 18 16 19 19 15 21 20 20 16 18 23 24 16 13 8 8 321

    End points

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    End points reporting groups
    Reporting group title
    A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk
    Reporting group description
    		 GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.

    Reporting group title
    B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Reporting group description
    		 GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.

    Reporting group title
    B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.

    Reporting group title
    B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.

    Reporting group title
    B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.

    Reporting group title
    B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.

    Reporting group title
    B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks

    Reporting group title
    C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Reporting group description
    		 GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk
    Reporting group description
    		 GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.

    Reporting group title
    D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

    Reporting group title
    D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Reporting group description
    		 GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.

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

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    End point title
    		 Percentage of participants achieving Sustained Virologic Response 12 weeks after the end of all study therapy (SVR12) [1]
    End point description
    Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a lower limit of quantification (LLoQ) of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR12 was defined as HCV RNA <25 IU/ml at 12 weeks after the end of all study therapy. 95% confidence intervals provided based on the Clopper-Pearson method. The Per-Protocol (PP) population was analyzed: all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point.
    End point type
    Primary
    End point timeframe
    12 weeks after end of therapy (up to 30 weeks)
    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: There was no formal efficacy hypothesis testing planned for this endpoint, and there were no between-group statistical comparisons performed.
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    22
    24
    12
    29
    29
    31
    30
    29
    31
    31
    30
    33
    33
    32
    29
    28
    29
    31
    19
    18
    Units: percentage of participants
        number (confidence interval 95%)
    100 (84.6 to 100)
    95.8 (78.9 to 99.9)
    100 (73.5 to 100)
    82.8 (64.2 to 94.2)
    100 (88.1 to 100)
    96.8 (83.3 to 99.9)
    90 (73.5 to 97.9)
    96.6 (82.2 to 99.9)
    100 (88.8 to 100)
    93.5 (78.6 to 99.2)
    100 (88.4 to 100)
    90.9 (75.7 to 98.1)
    100 (89.4 to 100)
    96.9 (83.8 to 99.9)
    96.6 (82.2 to 99.9)
    92.9 (76.5 to 99.1)
    93.1 (77.2 to 99.2)
    93.5 (78.6 to 99.2)
    47.4 (24.4 to 71.1)
    61.1 (35.7 to 82.7)
    No statistical analyses for this end point

    Primary: Percentage of participants experiencing at least one Adverse Event (AE) during the treatment period and first 14 follow-up days

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    End point title
    		 Percentage of participants experiencing at least one Adverse Event (AE) during the treatment period and first 14 follow-up days [2]
    End point description
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. All Participants as Treated (APaT) population was analyzed: all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
    End point type
    Primary
    End point timeframe
    From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 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: There was no formal safety hypothesis testing planned for this endpoint, and there were no between-group statistical comparisons performed.
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    25
    27 [3]
    12
    30
    33
    31
    31
    29
    32
    31
    32
    33
    33
    32
    29
    30
    30
    31
    20
    21
    Units: percentage of participants
        number (confidence interval 95%)
    88 (68.8 to 97.5)
    85.7 (67.3 to 96)
    91.7 (61.5 to 99.8)
    90 (73.5 to 97.9)
    72.7 (54.5 to 86.7)
    87.1 (70.2 to 96.4)
    77.4 (58.9 to 90.4)
    65.5 (45.7 to 82.1)
    87.5 (71 to 96.5)
    83.9 (66.3 to 94.5)
    81.3 (63.6 to 92.8)
    78.8 (61.1 to 91)
    97 (84.2 to 99.9)
    81.3 (63.6 to 92.8)
    65.5 (45.7 to 82.1)
    53.3 (34.3 to 71.7)
    73.3 (54.1 to 87.7)
    54.8 (36 to 72.7)
    85 (62.1 to 96.8)
    90.5 (69.6 to 98.8)
    Notes
    [3] - Excludes 1 A3 participant treated on A2, Total n=28
    No statistical analyses for this end point

    Primary: Percentage of participants discontinuing study therapy due to an AE during the treatment period and first 14 follow-up days

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    End point title
    		 Percentage of participants discontinuing study therapy due to an AE during the treatment period and first 14 follow-up days [4]
    End point description
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR’s product, was also an AE. APaT population was analyzed: all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
    End point type
    Primary
    End point timeframe
    From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)
    Notes
    [4] - 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: There was no formal safety hypothesis testing planned for this endpoint, and there were no between-group statistical comparisons performed.
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    25
    27 [5]
    12
    30
    33
    31
    31
    29
    32
    31
    32
    33
    33
    32
    29
    30
    30
    31
    20
    21
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 13.7)
    0 (0 to 12.3)
    0 (0 to 26.5)
    0 (0 to 11.6)
    0 (0 to 10.6)
    0 (0 to 11.2)
    0 (0 to 11.2)
    0 (0 to 11.9)
    6.3 (0.8 to 20.8)
    0 (0 to 11.2)
    3.1 (0.1 to 16.2)
    0 (0 to 10.6)
    0 (0 to 10.6)
    0 (0 to 10.9)
    0 (0 to 11.9)
    0 (0 to 11.6)
    0 (0 to 11.6)
    0 (0 to 11.2)
    0 (0 to 16.8)
    4.8 (0.1 to 23.8)
    Notes
    [5] - Excludes 1 A3 participant treated on A2, Total n=28
    No statistical analyses for this end point

    Secondary: Mean time to first achievement of undetectable hepatitis C virus ribonucleic acid (HCV RNA)

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    End point title
    		 Mean time to first achievement of undetectable hepatitis C virus ribonucleic acid (HCV RNA)
    End point description
    Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. Kaplan Meier summary statistics were used to characterize the time to first achievement of undetectable HCV RNA. The Full Analysis Set (FAS) was analyzed: all randomized participants who received ≥1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    25
    27
    13
    30
    33
    31
    31
    29
    32
    31
    32
    33
    33
    32
    29
    30
    30
    31
    20
    21
    Units: days
        arithmetic mean (standard error)
    21.7 ( 2.2 )
    19.2 ( 1.8 )
    23.4 ( 2.9 )
    27.9 ( 3 )
    30.7 ( 2.3 )
    32 ( 3 )
    37 ( 2.8 )
    33.2 ( 2.4 )
    33.1 ( 2.8 )
    33.7 ( 2.6 )
    31.9 ( 2.2 )
    37.4 ( 2.5 )
    37.4 ( 2.7 )
    42.7 ( 3.3 )
    27.6 ( 3 )
    29 ( 2.9 )
    23.7 ( 2.1 )
    34.5 ( 2.6 )
    30.1 ( 3.7 )
    19.8 ( 2.3 )
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving undetectable HCV RNA at Week 2

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    End point title
    		 Percentage of participants achieving undetectable HCV RNA at Week 2
    End point description
    HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population (all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point). 95% confidence intervals provided based on the Clopper-Pearson method.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    23
    25
    12
    29
    30
    31
    30
    29
    32
    31
    31
    33
    33
    32
    29
    30
    30
    31
    20
    20
    Units: percentage of participants
        number (confidence interval 95%)
    52.2 (30.6 to 73.2)
    44 (24.4 to 65.1)
    41.7 (15.2 to 72.3)
    44.8 (26.4 to 64.3)
    20 (7.7 to 38.6)
    16.1 (5.5 to 33.7)
    6.7 (0.8 to 22.1)
    10.3 (2.2 to 27.4)
    25 (11.5 to 43.4)
    16.1 (5.5 to 33.7)
    12.9 (3.6 to 29.8)
    6.1 (0.7 to 20.2)
    6.1 (0.7 to 20.2)
    6.3 (0.8 to 20.8)
    37.9 (20.7 to 57.7)
    40 (22.7 to 59.4)
    46.7 (28.3 to 65.7)
    12.9 (3.6 to 29.8)
    40 (19.1 to 63.9)
    70 (45.7 to 88.1)
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving undetectable HCV RNA at Week 4

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    End point title
    		 Percentage of participants achieving undetectable HCV RNA at Week 4
    End point description
    HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population (all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point). 95% confidence intervals provided based on the Clopper-Pearson method.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    23
    24
    12
    30
    30
    31
    30
    29
    32
    31
    30
    32
    33
    32
    29
    28
    30
    31
    20
    18
    Units: percentage of participants
        number (confidence interval 95%)
    73.9 (51.6 to 89.8)
    91.7 (73 to 99)
    75 (42.8 to 94.5)
    73.3 (54.1 to 87.7)
    83.3 (65.3 to 94.4)
    77.4 (58.9 to 90.4)
    60 (40.6 to 77.3)
    79.3 (60.3 to 92)
    71.9 (53.3 to 86.3)
    71 (52 to 85.8)
    83.3 (65.3 to 94.4)
    68.8 (50 to 83.9)
    69.7 (51.3 to 84.4)
    53.1 (34.7 to 70.9)
    75.9 (56.5 to 89.7)
    78.6 (59 to 91.7)
    86.7 (69.3 to 96.2)
    74.2 (55.4 to 88.1)
    50 (27.2 to 72.8)
    77.8 (52.4 to 93.6)
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving undetectable HCV RNA at Week 12

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    End point title
    		 Percentage of participants achieving undetectable HCV RNA at Week 12
    End point description
    HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. Undetectable HCV RNA was defined as below the 15.1 IU/ml limit of detection. The percentage of participants achieving undetectable HCV RNA and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point) as applicable. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis. 95% confidence intervals provided based on the Clopper-Pearson method.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    22
    24
    12
    0 [6]
    29
    31
    30
    29
    31
    31
    30
    32
    33
    32
    29
    28
    0 [7]
    0 [8]
    19
    20
    Units: percentage of participants
        number (confidence interval 95%)
    100 (84.6 to 100)
    100 (85.8 to 100)
    100 (73.5 to 100)
    ( to )
    100 (88.1 to 100)
    100 (88.8 to 100)
    93.3 (77.9 to 99.2)
    96.6 (82.2 to 99.9)
    100 (88.8 to 100)
    100 (88.8 to 100)
    100 (88.4 to 100)
    93.8 (79.2 to 99.2)
    100 (89.4 to 100)
    96.9 (83.8 to 99.9)
    93.1 (77.2 to 99.2)
    92.9 (76.5 to 99.1)
    ( to )
    ( to )
    47.7 (24.4 to 71.1)
    65 (40.8 to 84.6)
    Notes
    [6] - Participants only received 8 weeks of treatment and were therefore not analyzed at Week 12.
    [7] - Participants only received 8 weeks of treatment and were therefore not analyzed at Week 12.
    [8] - Participants only received 8 weeks of treatment and were therefore not analyzed at Week 12.
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving HCV RNA <25 IU/mL at Week 2

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    End point title
    		 Percentage of participants achieving HCV RNA <25 IU/mL at Week 2
    End point description
    HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW2 for each treatment arm of the PP Population (all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point). 95% confidence intervals provided based on the Clopper-Pearson method.
    End point type
    Secondary
    End point timeframe
    Week 2
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    23
    25
    12
    29
    30
    31
    30
    29
    32
    31
    31
    33
    33
    32
    29
    30
    30
    31
    20
    20
    Units: percentage of participants
        number (confidence interval 95%)
    91.3 (72 to 98.9)
    92 (74 to 99)
    91.7 (61.5 to 99.8)
    86.2 (68.3 to 96.1)
    73.3 (54.1 to 87.7)
    77.4 (58.9 to 90.4)
    60 (40.6 to 77.3)
    79.3 (60.3 to 92)
    78.1 (60 to 90.7)
    67.7 (48.6 to 83.3)
    77.4 (58.9 to 90.4)
    66.7 (48.2 to 82)
    57.6 (39.2 to 74.5)
    62.5 (43.7 to 78.9)
    89.7 (72.6 to 97.8)
    76.7 (57.7 to 90.1)
    76.7 (57.7 to 90.1)
    61.3 (42.2 to 78.2)
    70 (45.7 to 88.1)
    85 (62.1 to 96.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving HCV RNA <25 IU/mL at Week 4

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    End point title
    		 Percentage of participants achieving HCV RNA <25 IU/mL at Week 4
    End point description
    HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW4 for each treatment arm of the PP Population (all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point). 95% confidence intervals provided based on the Clopper-Pearson method.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    23
    24
    12
    30
    30
    31
    30
    29
    32
    31
    30
    32
    33
    32
    29
    28
    30
    31
    20
    18
    Units: percentage of participants
        number (confidence interval 95%)
    100 (85.2 to 100)
    100 (85.8 to 100)
    100 (73.5 to 100)
    100 (88.4 to 100)
    100 (88.4 to 100)
    100 (88.8 to 100)
    90 (73.5 to 97.9)
    100 (88.1 to 100)
    100 (89.1 to 100)
    90.3 (74.2 to 98)
    100 (88.4 to 100)
    96.9 (83.8 to 99.9)
    97 (84.2 to 99.9)
    93.8 (79.2 to 99.2)
    100 (88.1 to 100)
    100 (87.7 to 100)
    100 (88.4 to 100)
    96.8 (83.3 to 99.9)
    65 (40.8 to 84.6)
    83.3 (58.6 to 96.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving HCV RNA <25 IU/mL at Week 12

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    End point title
    		 Percentage of participants achieving HCV RNA <25 IU/mL at Week 12
    End point description
    HCV-RNA levels in plasma were measured using the Roche COBAS™ Taqman™ HCV Test (v.2.0) on blood samples drawn from each participant during treatment at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). The percentage of participants achieving HCV RNA levels <25 IU/ml and accompanying 95% CIs were reported at TW12 for each treatment arm of the PP Population (all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point) as applicable. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis. 95% confidence intervals provided based on the Clopper-Pearson method.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    22
    24
    12
    0 [9]
    29
    31
    30
    29
    31
    31
    30
    32
    33
    32
    29
    28
    0 [10]
    0 [11]
    19
    20
    Units: percentage of participants
        number (confidence interval 95%)
    100 (84.6 to 100)
    100 (85.8 to 100)
    100 (73.5 to 100)
    ( to )
    100 (88.1 to 100)
    100 (88.8 to 100)
    93.3 (77.9 to 99.2)
    100 (88.1 to 100)
    100 (88.8 to 100)
    100 (88.8 to 100)
    100 (88.4 to 100)
    100 (89.1 to 100)
    100 (89.4 to 100)
    96.9 (83.8 to 99.9)
    100 (88.1 to 100)
    92.9 (76.5 to 99.1)
    ( to )
    ( to )
    47.4 (24.4 to 71.1)
    75 (50.9 to 91.3)
    Notes
    [9] - Participants only received 8 weeks of treatment and were therefore not analyzed at Week 12.
    [10] - Participants only received 8 weeks of treatment and were therefore not analyzed at Week 12.
    [11] - Participants only received 8 weeks of treatment and were therefore not analyzed at Week 12.
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving Sustained Virologic Response 4 weeks after the end of all therapy (SVR4)

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    End point title
    		 Percentage of participants achieving Sustained Virologic Response 4 weeks after the end of all therapy (SVR4)
    End point description
    Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR4 was defined as HCV RNA <25 IU/ml at 4 weeks after the end of all study therapy. The percentage of participants achieving SVR4 and accompanying 95% CIs were reported at Follow-up Week (FW) 4 for each treatment arm of the PP Population (all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point). 95% confidence intervals provided based on the Clopper-Pearson method.
    End point type
    Secondary
    End point timeframe
    4 weeks after end of therapy (up to 22 weeks)
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    22
    24
    12
    30
    29
    31
    30
    29
    31
    31
    30
    33
    33
    32
    29
    29
    29
    31
    20
    18
    Units: percentage of participants
        number (confidence interval 95%)
    100 (84.6 to 100)
    95.8 (78.9 to 99.9)
    100 (73.5 to 100)
    93.3 (77.9 to 99.2)
    100 (88.1 to 100)
    96.8 (83.3 to 99.9)
    96.7 (82.8 to 99.9)
    96.6 (82.2 to 99.9)
    100 (88.8 to 100)
    96.8 (83.3 to 99.9)
    100 (88.4 to 100)
    93.9 (79.8 to 99.3)
    100 (89.4 to 100)
    96.9 (83.8 to 99.9)
    96.6 (82.2 to 99.9)
    93.1 (77.2 to 99.2)
    93.1 (77.2 to 99.2)
    96.8 (83.3 to 99.9)
    50 (27.2 to 72.8)
    61.1 (35.7 to 82.7)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of participants achieving Sustained Virologic Response 24 weeks after the end of all study therapy (SVR24)
    End point description
    Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS™ Taqman™ HCV Test, v2.0 at various time points prior to, during, and after dosing. The Roche COBAS Taqman HCV Test, v2.0 assay (High Pure System) had a LLoQ of 25 IU/mL and a limit of detection of 15.1 IU/mL (in plasma). SVR24 was defined as HCV RNA <25 IU/ml at 24 weeks after the end of all study therapy. The percentage of participants achieving SVR24 and accompanying 95% CIs were reported at FW24 for each treatment arm of the PP Population (all randomized participants who received ≥1 dose of study treatment and without important protocol deviations who had data available at the respective time point). 95% confidence intervals provided based on the Clopper-Pearson method.
    End point type
    Secondary
    End point timeframe
    24 weeks after end of therapy (up to 42 weeks)
    End point values
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Number of subjects analysed
    20
    24
    12
    28
    29
    31
    30
    29
    31
    29
    29
    33
    32
    32
    29
    27
    29
    31
    19
    17
    Units: percentage of participants
        number (confidence interval 95%)
    100 (83.2 to 100)
    95.8 (78.9 to 99.9)
    100 (73.5 to 100)
    78.6 (59 to 91.7)
    100 (88.1 to 100)
    96.8 (83.3 to 99.9)
    90 (73.5 to 97.9)
    96.6 (82.2 to 99.9)
    100 (88.8 to 100)
    93.1 (77.2 to 99.2)
    100 (88.1 to 100)
    90.9 (75.7 to 98.1)
    100 (89.1 to 100)
    96.9 (83.8 to 99.9)
    96.6 (82.2 to 99.9)
    88.9 (70.8 to 97.6)
    93.1 (77.2 to 99.2)
    93.5 (78.6 to 99.2)
    47.4 (24.4 to 71.1)
    58.8 (32.9 to 81.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment and Follow-up periods (up to 42 weeks)
    Adverse event reporting additional description
    All Participants as Treated (APaT) population; all randomized who received ≥1 dose of study treatment according to treatment actually received. One participant randomized to A3 arm was treated on A2 arm and thus was counted under the A2 arm (n=28).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk
    Reporting group description
    		 GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight

    Reporting group title
    A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight. Includes 1 additional participant that was randomized to A3 Arm but treated on A2 Arm.

    Reporting group title
    A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. Excludes 1 additional participant that was randomized to A3 Arm but treated on A2 Arm.

    Reporting group title
    B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Reporting group description
    		 GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight

    Reporting group title
    B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight

    Reporting group title
    B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks

    Reporting group title
    B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant

    Reporting group title
    B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks

    Reporting group title
    B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight

    Reporting group title
    B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks

    Reporting group title
    B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks

    Reporting group title
    B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight

    Reporting group title
    B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight

    Reporting group title
    B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks

    Reporting group title
    B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight

    Reporting group title
    B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk
    Reporting group description
    		 GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks

    Reporting group title
    C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk
    Reporting group description
    		 GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight

    Reporting group title
    D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk
    Reporting group description
    		 GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight

    Reporting group title
    C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk
    Reporting group description
    		 GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks

    Reporting group title
    D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Reporting group description
    		 GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight

    Serious adverse events
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    2 / 29 (6.90%)
    1 / 32 (3.13%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
    2 / 32 (6.25%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    1 / 29 (3.45%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    2 / 21 (9.52%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatic cancer
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholangitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk B7: TN C Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B9: NR Grazoprevir 100 mg + Elbasvir 50 mg-12 wk B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk B11: NR Grazoprevir 100 mg + Elbasvir 50 mg-18 wk B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg-12 wk C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg-8 wk D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 25 (76.00%)
    24 / 28 (85.71%)
    11 / 12 (91.67%)
    27 / 30 (90.00%)
    23 / 33 (69.70%)
    24 / 31 (77.42%)
    23 / 31 (74.19%)
    18 / 29 (62.07%)
    26 / 32 (81.25%)
    24 / 31 (77.42%)
    25 / 33 (75.76%)
    24 / 32 (75.00%)
    32 / 33 (96.97%)
    25 / 32 (78.13%)
    18 / 29 (62.07%)
    14 / 30 (46.67%)
    22 / 30 (73.33%)
    16 / 20 (80.00%)
    14 / 31 (45.16%)
    20 / 21 (95.24%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    2 / 31 (6.45%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hypertension
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    2 / 33 (6.06%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    1
    0
    1
    1
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    3 / 33 (9.09%)
    3 / 31 (9.68%)
    2 / 31 (6.45%)
    1 / 29 (3.45%)
    5 / 32 (15.63%)
    2 / 31 (6.45%)
    5 / 33 (15.15%)
    7 / 32 (21.88%)
    6 / 33 (18.18%)
    7 / 32 (21.88%)
    4 / 29 (13.79%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    2 / 20 (10.00%)
    2 / 31 (6.45%)
    3 / 21 (14.29%)
         occurrences all number
    0
    0
    0
    1
    3
    3
    2
    1
    6
    2
    7
    7
    6
    7
    5
    1
    1
    2
    2
    3
    Chills
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    2 / 32 (6.25%)
    2 / 31 (6.45%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 31 (3.23%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    3
    2
    1
    0
    1
    0
    0
    0
    0
    0
    2
    0
    Fatigue
         subjects affected / exposed
    9 / 25 (36.00%)
    5 / 28 (17.86%)
    4 / 12 (33.33%)
    15 / 30 (50.00%)
    10 / 33 (30.30%)
    6 / 31 (19.35%)
    11 / 31 (35.48%)
    6 / 29 (20.69%)
    9 / 32 (28.13%)
    6 / 31 (19.35%)
    10 / 33 (30.30%)
    6 / 32 (18.75%)
    15 / 33 (45.45%)
    8 / 32 (25.00%)
    2 / 29 (6.90%)
    2 / 30 (6.67%)
    11 / 30 (36.67%)
    2 / 20 (10.00%)
    3 / 31 (9.68%)
    3 / 21 (14.29%)
         occurrences all number
    9
    5
    4
    15
    10
    7
    11
    6
    10
    7
    12
    6
    16
    8
    2
    2
    11
    2
    3
    3
    Influenza like illness
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    2
    1
    1
    0
    0
    0
    0
    0
    Malaise
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    Oedema peripheral
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    1 / 12 (8.33%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    2 / 32 (6.25%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    1
    1
    0
    2
    0
    0
    0
    0
    0
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    1 / 12 (8.33%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 28 (7.14%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    1 / 33 (3.03%)
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    2 / 29 (6.90%)
    6 / 32 (18.75%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
    5 / 32 (15.63%)
    5 / 33 (15.15%)
    1 / 32 (3.13%)
    2 / 29 (6.90%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    2
    0
    1
    1
    1
    1
    2
    6
    1
    1
    5
    6
    1
    3
    1
    0
    1
    0
    1
    Dyspnoea
         subjects affected / exposed
    5 / 25 (20.00%)
    1 / 28 (3.57%)
    0 / 12 (0.00%)
    4 / 30 (13.33%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    5 / 32 (15.63%)
    1 / 31 (3.23%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    6 / 33 (18.18%)
    0 / 32 (0.00%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    5
    1
    0
    4
    0
    1
    1
    0
    5
    1
    2
    1
    7
    0
    1
    0
    2
    0
    0
    3
    Dyspnoea exertional
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    3 / 33 (9.09%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    1
    0
    1
    0
    0
    1
    3
    0
    0
    0
    1
    0
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    3 / 32 (9.38%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    1 / 33 (3.03%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    2 / 33 (6.06%)
    2 / 32 (6.25%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    2
    1
    2
    0
    0
    0
    0
    1
    1
    2
    2
    0
    0
    1
    0
    0
    1
    Productive cough
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    2
    Rhinorrhoea
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    Affect lability
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    1
    1
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    1
    Agitation
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 28 (3.57%)
    1 / 12 (8.33%)
    0 / 30 (0.00%)
    3 / 33 (9.09%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    3 / 33 (9.09%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    1
    1
    0
    3
    2
    0
    0
    0
    0
    1
    1
    3
    0
    0
    1
    1
    1
    0
    1
    Depression
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    2 / 12 (16.67%)
    0 / 30 (0.00%)
    2 / 33 (6.06%)
    1 / 31 (3.23%)
    2 / 31 (6.45%)
    0 / 29 (0.00%)
    1 / 32 (3.13%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    2 / 32 (6.25%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    3 / 30 (10.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    2
    0
    2
    1
    2
    0
    1
    2
    0
    2
    1
    0
    0
    0
    3
    0
    0
    1
    Insomnia
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 28 (7.14%)
    1 / 12 (8.33%)
    3 / 30 (10.00%)
    7 / 33 (21.21%)
    2 / 31 (6.45%)
    5 / 31 (16.13%)
    2 / 29 (6.90%)
    4 / 32 (12.50%)
    0 / 31 (0.00%)
    3 / 33 (9.09%)
    2 / 32 (6.25%)
    6 / 33 (18.18%)
    1 / 32 (3.13%)
    2 / 29 (6.90%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    3 / 20 (15.00%)
    0 / 31 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    3
    2
    1
    3
    8
    2
    5
    2
    4
    0
    3
    3
    6
    1
    3
    0
    1
    3
    0
    3
    Irritability
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 28 (3.57%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
    2 / 33 (6.06%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    2 / 31 (6.45%)
    1 / 33 (3.03%)
    2 / 32 (6.25%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    1
    1
    2
    2
    0
    0
    0
    0
    2
    1
    2
    2
    1
    1
    0
    2
    0
    0
    0
    Mood swings
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    3 / 30 (10.00%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    1
    1
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Nightmare
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    2 / 32 (6.25%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    2 / 33 (6.06%)
    3 / 31 (9.68%)
    4 / 31 (12.90%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    4 / 29 (13.79%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    1
    2
    3
    4
    0
    0
    1
    1
    0
    0
    0
    4
    0
    0
    0
    0
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 28 (7.14%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Amylase increased
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 28 (7.14%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    1 / 12 (8.33%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 31 (3.23%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    1
    0
    1
    0
    1
    1
    International normalised ratio increased
         subjects affected / exposed
    3 / 25 (12.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    2 / 33 (6.06%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    8
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Lipase increased
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 28 (3.57%)
    1 / 12 (8.33%)
    3 / 30 (10.00%)
    4 / 33 (12.12%)
    0 / 31 (0.00%)
    5 / 31 (16.13%)
    0 / 29 (0.00%)
    3 / 32 (9.38%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    3 / 20 (15.00%)
    0 / 31 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    1
    1
    1
    3
    5
    0
    6
    0
    3
    0
    0
    0
    5
    0
    1
    0
    2
    4
    0
    4
    Arthropod sting
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    1 / 12 (8.33%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Contusion
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    1 / 12 (8.33%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
    2 / 33 (6.06%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    1
    1
    2
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    1
    0
    1
    0
    1
    Nervous system disorders
    Disturbance in attention
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    3 / 30 (10.00%)
    1 / 33 (3.03%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    3
    1
    0
    0
    1
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    Dizziness
         subjects affected / exposed
    4 / 25 (16.00%)
    2 / 28 (7.14%)
    1 / 12 (8.33%)
    3 / 30 (10.00%)
    1 / 33 (3.03%)
    3 / 31 (9.68%)
    2 / 31 (6.45%)
    2 / 29 (6.90%)
    2 / 32 (6.25%)
    4 / 31 (12.90%)
    1 / 33 (3.03%)
    2 / 32 (6.25%)
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    4
    2
    1
    3
    1
    3
    2
    2
    2
    4
    1
    2
    2
    0
    1
    0
    2
    1
    0
    1
    Dysgeusia
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    2 / 32 (6.25%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    1
    0
    2
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    Headache
         subjects affected / exposed
    4 / 25 (16.00%)
    6 / 28 (21.43%)
    5 / 12 (41.67%)
    7 / 30 (23.33%)
    7 / 33 (21.21%)
    10 / 31 (32.26%)
    2 / 31 (6.45%)
    4 / 29 (13.79%)
    11 / 32 (34.38%)
    10 / 31 (32.26%)
    6 / 33 (18.18%)
    10 / 32 (31.25%)
    6 / 33 (18.18%)
    10 / 32 (31.25%)
    4 / 29 (13.79%)
    2 / 30 (6.67%)
    6 / 30 (20.00%)
    5 / 20 (25.00%)
    5 / 31 (16.13%)
    5 / 21 (23.81%)
         occurrences all number
    4
    6
    5
    7
    9
    11
    3
    5
    13
    12
    6
    12
    7
    10
    5
    2
    6
    5
    6
    5
    Somnolence
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    1
    0
    0
    0
    0
    Tremor
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 28 (7.14%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    4 / 32 (12.50%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    2 / 32 (6.25%)
    5 / 33 (15.15%)
    0 / 32 (0.00%)
    2 / 29 (6.90%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    3 / 20 (15.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    3
    2
    0
    1
    0
    0
    1
    0
    4
    0
    0
    2
    5
    0
    2
    0
    0
    3
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    2 / 33 (6.06%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    1 / 12 (8.33%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    1 / 32 (3.13%)
    2 / 31 (6.45%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    1
    2
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 25 (0.00%)
    2 / 28 (7.14%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    2 / 33 (6.06%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    2 / 32 (6.25%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    0
    2
    0
    0
    2
    1
    0
    1
    2
    1
    1
    1
    4
    3
    1
    0
    0
    1
    0
    3
    Abdominal pain upper
         subjects affected / exposed
    5 / 25 (20.00%)
    2 / 28 (7.14%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
    3 / 33 (9.09%)
    0 / 31 (0.00%)
    3 / 31 (9.68%)
    0 / 29 (0.00%)
    3 / 32 (9.38%)
    0 / 31 (0.00%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    3 / 33 (9.09%)
    5 / 32 (15.63%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    5
    3
    1
    2
    3
    0
    3
    0
    3
    0
    2
    1
    4
    5
    0
    1
    1
    1
    0
    2
    Constipation
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    3 / 33 (9.09%)
    0 / 32 (0.00%)
    4 / 33 (12.12%)
    2 / 32 (6.25%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    1
    1
    1
    0
    0
    4
    0
    5
    2
    0
    1
    1
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    3 / 25 (12.00%)
    5 / 28 (17.86%)
    1 / 12 (8.33%)
    5 / 30 (16.67%)
    2 / 33 (6.06%)
    4 / 31 (12.90%)
    1 / 31 (3.23%)
    2 / 29 (6.90%)
    4 / 32 (12.50%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    3 / 33 (9.09%)
    7 / 32 (21.88%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    2 / 31 (6.45%)
    0 / 21 (0.00%)
         occurrences all number
    3
    5
    1
    5
    2
    5
    1
    2
    4
    1
    0
    0
    3
    7
    1
    0
    1
    1
    3
    0
    Dry mouth
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    1 / 33 (3.03%)
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
    1 / 32 (3.13%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    1
    1
    1
    1
    1
    1
    1
    0
    1
    2
    1
    1
    0
    2
    1
    0
    1
    Dyspepsia
         subjects affected / exposed
    3 / 25 (12.00%)
    2 / 28 (7.14%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    1 / 33 (3.03%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    3 / 33 (9.09%)
    1 / 32 (3.13%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    1 / 31 (3.23%)
    3 / 21 (14.29%)
         occurrences all number
    4
    2
    0
    1
    1
    0
    0
    0
    0
    0
    1
    1
    3
    1
    0
    0
    0
    0
    1
    3
    Flatulence
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 28 (3.57%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    2 / 33 (6.06%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    1 / 32 (3.13%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    0
    2
    0
    0
    0
    1
    1
    1
    0
    1
    1
    1
    0
    1
    0
    0
    0
    Frequent bowel movements
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    2 / 32 (6.25%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    2 / 31 (6.45%)
    0 / 29 (0.00%)
    2 / 32 (6.25%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    2
    0
    2
    1
    0
    0
    1
    1
    0
    0
    1
    1
    0
    1
    Nausea
         subjects affected / exposed
    5 / 25 (20.00%)
    7 / 28 (25.00%)
    2 / 12 (16.67%)
    8 / 30 (26.67%)
    6 / 33 (18.18%)
    5 / 31 (16.13%)
    4 / 31 (12.90%)
    0 / 29 (0.00%)
    4 / 32 (12.50%)
    4 / 31 (12.90%)
    2 / 33 (6.06%)
    4 / 32 (12.50%)
    5 / 33 (15.15%)
    1 / 32 (3.13%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    6 / 30 (20.00%)
    3 / 20 (15.00%)
    3 / 31 (9.68%)
    6 / 21 (28.57%)
         occurrences all number
    5
    7
    2
    8
    6
    5
    4
    0
    5
    5
    2
    4
    6
    1
    0
    1
    6
    3
    3
    7
    Tooth impacted
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    1 / 12 (8.33%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 25 (8.00%)
    4 / 28 (14.29%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
    2 / 33 (6.06%)
    1 / 31 (3.23%)
    2 / 31 (6.45%)
    2 / 29 (6.90%)
    3 / 32 (9.38%)
    2 / 31 (6.45%)
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    3 / 33 (9.09%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    2
    5
    0
    2
    2
    1
    2
    2
    5
    2
    3
    0
    3
    0
    0
    1
    1
    0
    0
    3
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    2 / 33 (6.06%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 28 (3.57%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    2 / 32 (6.25%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    1
    Dermatitis contact
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 28 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    2 / 31 (6.45%)
    0 / 29 (0.00%)
    4 / 32 (12.50%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    4 / 33 (12.12%)
    0 / 32 (0.00%)
    1 / 29 (3.45%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 31 (3.23%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    2
    0
    4
    1
    0
    1
    4
    0
    1
    1
    1
    0
    1
    1
    Eczema
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    2 / 32 (6.25%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    3
    Pruritus
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 28 (7.14%)
    0 / 12 (0.00%)
    6 / 30 (20.00%)
    4 / 33 (12.12%)
    0 / 31 (0.00%)
    2 / 31 (6.45%)
    1 / 29 (3.45%)
    5 / 32 (15.63%)
    2 / 31 (6.45%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    10 / 33 (30.30%)
    1 / 32 (3.13%)
    3 / 29 (10.34%)
    0 / 30 (0.00%)
    4 / 30 (13.33%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    1
    2
    0
    6
    4
    0
    2
    1
    5
    2
    2
    1
    10
    1
    3
    0
    4
    1
    0
    3
    Rash
         subjects affected / exposed
    1 / 25 (4.00%)
    5 / 28 (17.86%)
    1 / 12 (8.33%)
    0 / 30 (0.00%)
    3 / 33 (9.09%)
    1 / 31 (3.23%)
    3 / 31 (9.68%)
    0 / 29 (0.00%)
    7 / 32 (21.88%)
    0 / 31 (0.00%)
    3 / 33 (9.09%)
    3 / 32 (9.38%)
    3 / 33 (9.09%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    3 / 30 (10.00%)
    3 / 20 (15.00%)
    1 / 31 (3.23%)
    2 / 21 (9.52%)
         occurrences all number
    1
    5
    1
    0
    4
    1
    4
    0
    8
    0
    3
    4
    3
    0
    0
    0
    3
    6
    1
    2
    Rash pruritic
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    2 / 31 (6.45%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 28 (3.57%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    2 / 33 (6.06%)
    2 / 31 (6.45%)
    2 / 31 (6.45%)
    3 / 29 (10.34%)
    2 / 32 (6.25%)
    2 / 31 (6.45%)
    0 / 33 (0.00%)
    2 / 32 (6.25%)
    4 / 33 (12.12%)
    4 / 32 (12.50%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    1 / 31 (3.23%)
    0 / 21 (0.00%)
         occurrences all number
    2
    1
    0
    1
    3
    2
    2
    4
    2
    2
    0
    2
    4
    4
    0
    2
    1
    0
    1
    0
    Back pain
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    2 / 33 (6.06%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
    4 / 32 (12.50%)
    2 / 31 (6.45%)
    0 / 33 (0.00%)
    3 / 32 (9.38%)
    1 / 33 (3.03%)
    5 / 32 (15.63%)
    1 / 29 (3.45%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    0
    2
    2
    0
    2
    4
    2
    0
    4
    1
    5
    1
    1
    0
    1
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Muscle spasms
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    2 / 33 (6.06%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    2 / 33 (6.06%)
    2 / 32 (6.25%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    1
    2
    1
    0
    1
    1
    0
    0
    1
    2
    2
    0
    1
    0
    0
    0
    0
    Muscular weakness
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    2 / 32 (6.25%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    1 / 33 (3.03%)
    2 / 32 (6.25%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    1
    1
    2
    0
    0
    0
    0
    0
    0
    Myalgia
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 28 (3.57%)
    2 / 12 (16.67%)
    0 / 30 (0.00%)
    1 / 33 (3.03%)
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    6 / 33 (18.18%)
    1 / 32 (3.13%)
    6 / 33 (18.18%)
    4 / 32 (12.50%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    3 / 31 (9.68%)
    0 / 21 (0.00%)
         occurrences all number
    2
    1
    2
    0
    1
    1
    1
    1
    0
    1
    8
    1
    6
    4
    1
    0
    1
    0
    4
    0
    Neck pain
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    1 / 33 (3.03%)
    2 / 31 (6.45%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    2 / 32 (6.25%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    4 / 33 (12.12%)
    0 / 32 (0.00%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    1
    0
    2
    2
    1
    0
    4
    0
    1
    0
    0
    0
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    1 / 32 (3.13%)
    2 / 31 (6.45%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    0 / 29 (0.00%)
    2 / 32 (6.25%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    1 / 33 (3.03%)
    1 / 32 (3.13%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    2
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    0 / 33 (0.00%)
    1 / 31 (3.23%)
    1 / 31 (3.23%)
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    1
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 25 (8.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    3 / 33 (9.09%)
    1 / 31 (3.23%)
    2 / 31 (6.45%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    4 / 31 (12.90%)
    1 / 33 (3.03%)
    3 / 32 (9.38%)
    5 / 33 (15.15%)
    0 / 32 (0.00%)
    1 / 29 (3.45%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    2
    0
    0
    1
    3
    1
    2
    0
    0
    5
    1
    3
    6
    0
    1
    0
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 25 (4.00%)
    0 / 28 (0.00%)
    0 / 12 (0.00%)
    0 / 30 (0.00%)
    1 / 33 (3.03%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    1 / 32 (3.13%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    1 / 32 (3.13%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    Sinusitis
         subjects affected / exposed
    0 / 25 (0.00%)
    3 / 28 (10.71%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    0 / 29 (0.00%)
    0 / 32 (0.00%)
    0 / 31 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    2 / 33 (6.06%)
    0 / 32 (0.00%)
    2 / 29 (6.90%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    2 / 31 (6.45%)
    0 / 21 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    2
    0
    0
    0
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 25 (8.00%)
    1 / 28 (3.57%)
    0 / 12 (0.00%)
    3 / 30 (10.00%)
    1 / 33 (3.03%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    2 / 29 (6.90%)
    3 / 32 (9.38%)
    1 / 31 (3.23%)
    1 / 33 (3.03%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    3 / 20 (15.00%)
    0 / 31 (0.00%)
    5 / 21 (23.81%)
         occurrences all number
    2
    1
    0
    3
    1
    0
    0
    2
    3
    1
    1
    0
    0
    0
    0
    1
    0
    3
    0
    5
    Urinary tract infection
         subjects affected / exposed
    1 / 25 (4.00%)
    2 / 28 (7.14%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
    0 / 33 (0.00%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
    1 / 29 (3.45%)
    0 / 32 (0.00%)
    1 / 31 (3.23%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 33 (0.00%)
    0 / 32 (0.00%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 20 (0.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    2
    0
    1
    0
    0
    0
    3
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 25 (4.00%)
    1 / 28 (3.57%)
    0 / 12 (0.00%)
    4 / 30 (13.33%)
    0 / 33 (0.00%)
    2 / 31 (6.45%)
    1 / 31 (3.23%)
    2 / 29 (6.90%)
    1 / 32 (3.13%)
    2 / 31 (6.45%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    2 / 33 (6.06%)
    1 / 32 (3.13%)
    0 / 29 (0.00%)
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    1 / 20 (5.00%)
    0 / 31 (0.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    1
    0
    5
    0
    2
    1
    2
    1
    2
    2
    1
    2
    1
    0
    1
    1
    1
    0
    0

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Jun 2013
    The primary reason for protocol amendment 1 (AM1) was to add Part B which included 4 participant populations in 13 treatment arms, comprising an additional 390 subjects. Participants were randomized to treatment with 100 mg of grazoprevir in combination with 50 mg of elbasvir plus/minus RBV. Two study objectives were added, which were applicable only to study Part B within the HIV co-infected participant population.
    15 Aug 2013
    The primary changes in AM2 were to revise/update the following: stopping rules for early trial termination due to failure criteria, Part B eligibility criteria, list of prohibited concomitant medications, and the definition for treatment naïve, non-cirrhotic HIV co-infection participants. Discontinuation criteria were also added for the HIV-coinfected arm.
    25 Nov 2013
    AM3 added a Week 8 Follow-Up Visit to the protocol, removed the futility rule at Treatment Week 4 for Part B, revised the list of prohibited medications, and clarified events of clinical interest.
    10 Jan 2014
    The primary reason for AM4 was to add 2 additional study arms to Part B: Arm 1.5 in treatment-naïve (noncirrhotic) participants treated with grazoprevir 100 mg + elbasvir 50 mg for 8 weeks (n=30), and Arm 14 in treatment-naïve (non-cirrhotic) participants co-infected with HIV treated with grazoprevir 100 mg + elbasvir 50 mg for 8 weeks (n=30). Enrollment was canceled for study Arms 1.5 and 14 of Part B in Protocol Amendment No. 5 after data became available for treatment of participants with HCV GT1a for 8 weeks.
    21 Feb 2014
    AM5 added Part C to include 2 arms studying 8-week durations in treatment-naïve noncirrhotic, HCV GT1b-infected participants. In addition, enrollment was canceled for study Arms 1.5 and 14 of Part B.
    03 Apr 2014
    AM6 added Part D to include 2 arms studying 12- and 18-week treatment durations in treatment-naïve, non-cirrhotic, HCV GT3-infected populations.

    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
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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