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A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035) (C-WORTHy)

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ClinicalTrials.gov Identifier: NCT01717326
Recruitment Status : Completed
First Posted : October 30, 2012
Results First Posted : May 30, 2016
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Grazoprevir
Drug: Elbasvir
Drug: Placebo to Elbasvir
Drug: Ribavirin
Enrollment 573
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 Details 573 participants were randomized on study. 65 TN NC GT1 participants were randomized in Part A. Part B randomized 94 TN NC participants, 123 TN C participants, 130 NR participants (C and NC), and 59 TN HIV coinfected participants. Part C randomized 61 TN NC GT1b participants, and Part D randomized 41 TN NC GT3 participants.
Arm/Group Title 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
Hide Arm/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. 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. GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. 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. GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks. 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. 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.
Period Title: Overall Study
Started 25 27 13 30 33 31 31 29 32 31 32 33 33 32 29 30 30 31 20 21
Treated 25 28 [1] 12 [2] 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
Reason Not Completed
Death             0             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0
Lost to Follow-up             3             0             0             2             1             0             1             0             0             0             1             0             0             0             0             2             1             0             2             3
Physician Decision             0             0             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0
Protocol Violation             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0             0             0             0
Withdrawal by Subject             0             1             0             0             0             0             0             0             0             1             0             0             1             0             0             1             0             0             2             3
[1]
Number includes 1 additional participant randomized to A3 but treated on A2
[2]
Number excludes 1 participant randomized to A3 but treated on Arm A2
Arm/Group Title 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
Hide Arm/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. 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. GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. 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. GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 25 27 13 30 33 31 31 29 32 31 32 33 33 32 29 30 30 31 20 21 573
Hide Baseline Analysis Population Description
Full Analysis Set (FAS); all randomized participants who received ≥1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 27 participants 13 participants 30 participants 33 participants 31 participants 31 participants 29 participants 32 participants 31 participants 32 participants 33 participants 33 participants 32 participants 29 participants 30 participants 30 participants 31 participants 20 participants 21 participants 573 participants
48.7  (12.5) 43.9  (12.6) 43.3  (13.5) 48.4  (11.9) 49.7  (11.5) 53.6  (8.4) 57.0  (7.0) 59.0  (7.8) 58.8  (8.2) 58.9  (8.0) 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) 49.0  (11.5) 42.4  (10.8) 51.9  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 27 participants 13 participants 30 participants 33 participants 31 participants 31 participants 29 participants 32 participants 31 participants 32 participants 33 participants 33 participants 32 participants 29 participants 30 participants 30 participants 31 participants 20 participants 21 participants 573 participants
Female
13
  52.0%
17
  63.0%
6
  46.2%
12
  40.0%
15
  45.5%
15
  48.4%
12
  38.7%
10
  34.5%
17
  53.1%
10
  32.3%
12
  37.5%
13
  39.4%
17
  51.5%
14
  43.8%
6
  20.7%
6
  20.0%
14
  46.7%
18
  58.1%
12
  60.0%
13
  61.9%
252
  44.0%
Male
12
  48.0%
10
  37.0%
7
  53.8%
18
  60.0%
18
  54.5%
16
  51.6%
19
  61.3%
19
  65.5%
15
  46.9%
21
  67.7%
20
  62.5%
20
  60.6%
16
  48.5%
18
  56.3%
23
  79.3%
24
  80.0%
16
  53.3%
13
  41.9%
8
  40.0%
8
  38.1%
321
  56.0%
1.Primary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After the End of All Study Therapy (SVR12)
Hide 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 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.
Time Frame 12 weeks after end of therapy (up to 30 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-Protocol (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.
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 22 24 12 29 29 31 30 29 31 31 30 33 33 32 29 28 29 31 19 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(84.6 to 100.0)
95.8
(78.9 to 99.9)
100.0
(73.5 to 100.0)
82.8
(64.2 to 94.2)
100.0
(88.1 to 100.0)
96.8
(83.3 to 99.9)
90.0
(73.5 to 97.9)
96.6
(82.2 to 99.9)
100.0
(88.8 to 100.0)
93.5
(78.6 to 99.2)
100.0
(88.4 to 100.0)
90.9
(75.7 to 98.1)
100.0
(89.4 to 100.0)
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)
2.Primary Outcome
Title Percentage of Participants Experiencing at Least One Adverse Event (AE) During the Treatment Period and First 14 Follow-up Days
Hide 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.
Time Frame From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)
Hide Outcome Measure Data
Hide Analysis Population 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).
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 25 28 12 30 33 31 31 29 32 31 32 33 33 32 29 30 30 31 20 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
88.0
(68.8 to 97.5)
85.7
(67.3 to 96.0)
91.7
(61.5 to 99.8)
90.0
(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
(71.0 to 96.5)
83.9
(66.3 to 94.5)
81.3
(63.6 to 92.8)
78.8
(61.1 to 91.0)
97.0
(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
(36.0 to 72.7)
85.0
(62.1 to 96.8)
90.5
(69.6 to 98.8)
3.Primary Outcome
Title Percentage of Participants Discontinuing Study Therapy Due to an AE During the Treatment Period and First 14 Follow-up Days
Hide 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.
Time Frame From Day 1 [post-dose] through 14 days following last dose of study drug (up to 20 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 25 28 12 30 33 31 31 29 32 31 32 33 33 32 29 30 30 31 20 21
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0.0
(0.0 to 13.7)
0.0
(0.0 to 12.3)
0.0
(0.0 to 26.5)
0.0
(0.0 to 11.6)
0.0
(0.0 to 10.6)
0.0
(0.0 to 11.2)
0.0
(0.0 to 11.2)
0.0
(0.0 to 11.9)
6.3
(0.8 to 20.8)
0.0
(0.0 to 11.2)
3.1
(0.1 to 16.2)
0.0
(0.0 to 10.6)
0.0
(0.0 to 10.6)
0.0
(0.0 to 10.9)
0.0
(0.0 to 11.9)
0.0
(0.0 to 11.6)
0.0
(0.0 to 11.6)
0.0
(0.0 to 11.2)
0.0
(0.0 to 16.8)
4.8
(0.1 to 23.8)
4.Secondary Outcome
Title Mean Time to First Achievement of Undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA)
Hide 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.
Time Frame From first dose of study medication until first achievement of undetectable HCV RNA (up to 18 weeks of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; all randomized participants who received ≥1 dose of study treatment.
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 25 27 13 30 33 31 31 29 32 31 32 33 33 32 29 30 30 31 20 21
Mean (Standard Error)
Unit of Measure: days
21.7  (2.2) 19.2  (1.8) 23.4  (2.9) 27.9  (3.0) 30.7  (2.3) 32.0  (3.0) 37.0  (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  (3.0) 29.0  (2.9) 23.7  (2.1) 34.5  (2.6) 30.1  (3.7) 19.8  (2.3)
5.Secondary Outcome
Title Percentage of Participants Achieving Undetectable HCV RNA at Week 2
Hide 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. 95% confidence intervals provided based on the Clopper-Pearson method.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 23 25 12 29 30 31 30 29 32 31 31 33 33 32 29 30 30 31 20 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52.2
(30.6 to 73.2)
44.0
(24.4 to 65.1)
41.7
(15.2 to 72.3)
44.8
(26.4 to 64.3)
20.0
(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)
25.0
(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)
40.0
(22.7 to 59.4)
46.7
(28.3 to 65.7)
12.9
(3.6 to 29.8)
40.0
(19.1 to 63.9)
70.0
(45.7 to 88.1)
6.Secondary Outcome
Title Percentage of Participants Achieving Undetectable HCV RNA at Week 4
Hide 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. 95% confidence intervals provided based on the Clopper-Pearson method.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 23 24 12 30 30 31 30 29 32 31 30 32 33 32 29 28 30 31 20 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.9
(51.6 to 89.8)
91.7
(73.0 to 99.0)
75.0
(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)
60.0
(40.6 to 77.3)
79.3
(60.3 to 92.0)
71.9
(53.3 to 86.3)
71.0
(52.0 to 85.8)
83.3
(65.3 to 94.4)
68.8
(50.0 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
(59.0 to 91.7)
86.7
(69.3 to 96.2)
74.2
(55.4 to 88.1)
50.0
(27.2 to 72.8)
77.8
(52.4 to 93.6)
7.Secondary Outcome
Title Percentage of Participants Achieving Undetectable HCV RNA at Week 12
Hide 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 (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 22 24 12 0 29 31 30 29 31 31 30 32 33 32 29 28 0 0 19 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(84.6 to 100.0)
100.0
(85.8 to 100.0)
100.0
(73.5 to 100.0)
100.0
(88.1 to 100.0)
100.0
(88.8 to 100.0)
93.3
(77.9 to 99.2)
96.6
(82.2 to 99.9)
100.0
(88.8 to 100.0)
100.0
(88.8 to 100.0)
100.0
(88.4 to 100.0)
93.8
(79.2 to 99.2)
100.0
(89.4 to 100.0)
96.9
(83.8 to 99.9)
93.1
(77.2 to 99.2)
92.9
(76.5 to 99.1)
47.7
(24.4 to 71.1)
65.0
(40.8 to 84.6)
8.Secondary Outcome
Title Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 2
Hide 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. 95% confidence intervals provided based on the Clopper-Pearson method.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 23 25 12 29 30 31 30 29 32 31 31 33 33 32 29 30 30 31 20 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.3
(72.0 to 98.9)
92.0
(74.0 to 99.0)
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)
60.0
(40.6 to 77.3)
79.3
(60.3 to 92.0)
78.1
(60.0 to 90.7)
67.7
(48.6 to 83.3)
77.4
(58.9 to 90.4)
66.7
(48.2 to 82.0)
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)
70.0
(45.7 to 88.1)
85.0
(62.1 to 96.8)
9.Secondary Outcome
Title Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 4
Hide 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. 95% confidence intervals provided based on the Clopper-Pearson method.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 23 24 12 30 30 31 30 29 32 31 30 32 33 32 29 28 30 31 20 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(85.2 to 100.0)
100.0
(85.8 to 100.0)
100.0
(73.5 to 100.0)
100.0
(88.4 to 100.0)
100.0
(88.4 to 100.0)
100.0
(88.8 to 100.0)
90.0
(73.5 to 97.9)
100.0
(88.1 to 100.0)
100.0
(89.1 to 100.0)
90.3
(74.2 to 98.0)
100.0
(88.4 to 100.0)
96.9
(83.8 to 99.9)
97.0
(84.2 to 99.9)
93.8
(79.2 to 99.2)
100.0
(88.1 to 100.0)
100.0
(87.7 to 100.0)
100.0
(88.4 to 100.0)
96.8
(83.3 to 99.9)
65.0
(40.8 to 84.6)
83.3
(58.6 to 96.4)
10.Secondary Outcome
Title Percentage of Participants Achieving HCV RNA <25 IU/mL at Week 12
Hide 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 (as applicable). 95% confidence intervals provided based on the Clopper-Pearson method.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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. The B1, C1, and C2 arms only received 8 weeks of treatment and were thus excluded from this analysis.
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 22 24 12 0 29 31 30 29 31 31 30 32 33 32 29 28 0 0 19 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(84.6 to 100.0)
100.0
(85.8 to 100.0)
100.0
(73.5 to 100.0)
100.0
(88.1 to 100.0)
100.0
(88.8 to 100.0)
93.3
(77.9 to 99.2)
100.0
(88.1 to 100.0)
100.0
(88.8 to 100.0)
100.0
(88.8 to 100.0)
100.0
(88.4 to 100.0)
100.0
(89.1 to 100.0)
100.0
(89.4 to 100.0)
96.9
(83.8 to 99.9)
100.0
(88.1 to 100.0)
92.9
(76.5 to 99.1)
47.4
(24.4 to 71.1)
75.0
(50.9 to 91.3)
11.Secondary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response 4 Weeks After the End of All Therapy (SVR4)
Hide 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. 95% confidence intervals provided based on the Clopper-Pearson method.
Time Frame 4 weeks after end of therapy (up to 22 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 22 24 12 30 29 31 30 29 31 31 30 33 33 32 29 29 29 31 20 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(84.6 to 100.0)
95.8
(78.9 to 99.9)
100.0
(73.5 to 100.0)
93.3
(77.9 to 99.2)
100.0
(88.1 to 100.0)
96.8
(83.3 to 99.9)
96.7
(82.8 to 99.9)
96.6
(82.2 to 99.9)
100.0
(88.8 to 100.0)
96.8
(83.3 to 99.9)
100.0
(88.4 to 100.0)
93.9
(79.8 to 99.3)
100.0
(89.4 to 100.0)
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)
50.0
(27.2 to 72.8)
61.1
(35.7 to 82.7)
12.Secondary Outcome
Title Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After the End of All Study Therapy (SVR24)
Hide 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. 95% confidence intervals provided based on the Clopper-Pearson method.
Time Frame 24 weeks after end of therapy (up to 42 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/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.
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.
GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
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.
GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
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.
GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
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.
GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
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.
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.
Overall Number of Participants Analyzed 20 24 12 28 29 31 30 29 31 29 29 33 32 32 29 27 29 31 19 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(83.2 to 100.0)
95.8
(78.9 to 99.9)
100.0
(73.5 to 100.0)
78.6
(59.0 to 91.7)
100.0
(88.1 to 100.0)
96.8
(83.3 to 99.9)
90.0
(73.5 to 97.9)
96.6
(82.2 to 99.9)
100.0
(88.8 to 100.0)
93.1
(77.2 to 99.2)
100.0
(88.1 to 100.0)
90.9
(75.7 to 98.1)
100.0
(89.1 to 100.0)
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)
Time Frame Treatment and Follow-up periods (up to 42 weeks)
Adverse Event Reporting 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).
 
Arm/Group Title 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
Hide Arm/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. 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. GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. 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. GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks. 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. GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks. 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. GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks. 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. 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.
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide 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 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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   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%)      2/32 (6.25%)      1/33 (3.03%)      0/33 (0.00%)      1/32 (3.13%)      1/29 (3.45%)      2/30 (6.67%)      1/30 (3.33%)      0/31 (0.00%)      0/20 (0.00%)      2/21 (9.52%)    
Cardiac disorders                                         
Atrial fibrillation  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Gastrointestinal disorders                                         
Abdominal pain  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 1/29 (3.45%)  1 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/29 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Gastritis  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 1/32 (3.13%)  1 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Nausea  1  1/25 (4.00%)  1 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
General disorders                                         
Asthenia  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 1/29 (3.45%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Chest pain  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 1/31 (3.23%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Hepatobiliary disorders                                         
Cholangitis  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Cholecystitis acute  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1
Infections and infestations                                         
Bacteraemia  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Scrotal abscess  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 1/33 (3.03%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Staphylococcal infection  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Injury, poisoning and procedural complications                                         
Road traffic accident  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                                         
Hepatic cancer  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Transitional cell carcinoma  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 1/29 (3.45%)  1 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Psychiatric disorders                                         
Depression  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1
Renal and urinary disorders                                         
Hydronephrosis  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   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%)      24/32 (75.00%)      25/33 (75.76%)      32/33 (96.97%)      25/32 (78.13%)      18/29 (62.07%)      14/30 (46.67%)      22/30 (73.33%)      14/31 (45.16%)      16/20 (80.00%)      20/21 (95.24%)    
Blood and lymphatic system disorders                                         
Anaemia  1  3/25 (12.00%)  3 2/28 (7.14%)  2 0/12 (0.00%)  0 1/30 (3.33%)  1 0/33 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1 0/29 (0.00%)  0 4/32 (12.50%)  4 0/31 (0.00%)  0 2/32 (6.25%)  2 0/33 (0.00%)  0 5/33 (15.15%)  5 0/32 (0.00%)  0 2/29 (6.90%)  2 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 3/20 (15.00%)  3 0/21 (0.00%)  0
Cardiac disorders                                         
Palpitations  1  0/25 (0.00%)  0 0/28 (0.00%)  0 1/12 (8.33%)  1 1/30 (3.33%)  1 2/33 (6.06%)  2 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 1/33 (3.03%)  1 1/32 (3.13%)  1 0/29 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/31 (0.00%)  0 1/20 (5.00%)  1 1/21 (4.76%)  1
Ear and labyrinth disorders                                         
Ear pain  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 2/33 (6.06%)  2 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1
Gastrointestinal disorders                                         
Abdominal discomfort  1  0/25 (0.00%)  0 0/28 (0.00%)  0 1/12 (8.33%)  1 0/30 (0.00%)  0 0/33 (0.00%)  0 1/31 (3.23%)  1 0/31 (0.00%)  0 0/29 (0.00%)  0 1/32 (3.13%)  1 2/31 (6.45%)  2 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 1/29 (3.45%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Abdominal pain  1  0/25 (0.00%)  0 2/28 (7.14%)  2 0/12 (0.00%)  0 0/30 (0.00%)  0 2/33 (6.06%)  2 1/31 (3.23%)  1 0/31 (0.00%)  0 1/29 (3.45%)  1 2/32 (6.25%)  2 1/31 (3.23%)  1 1/32 (3.13%)  1 1/33 (3.03%)  1 2/33 (6.06%)  4 1/32 (3.13%)  3 1/29 (3.45%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 1/20 (5.00%)  1 3/21 (14.29%)  3
Abdominal pain upper  1  5/25 (20.00%)  5 2/28 (7.14%)  3 1/12 (8.33%)  1 2/30 (6.67%)  2 3/33 (9.09%)  3 0/31 (0.00%)  0 3/31 (9.68%)  3 0/29 (0.00%)  0 3/32 (9.38%)  3 0/31 (0.00%)  0 1/32 (3.13%)  1 2/33 (6.06%)  2 3/33 (9.09%)  4 5/32 (15.63%)  5 0/29 (0.00%)  0 1/30 (3.33%)  1 1/30 (3.33%)  1 0/31 (0.00%)  0 1/20 (5.00%)  1 2/21 (9.52%)  2
Constipation  1  1/25 (4.00%)  2 0/28 (0.00%)  0 0/12 (0.00%)  0 1/30 (3.33%)  1 0/33 (0.00%)  0 1/31 (3.23%)  1 1/31 (3.23%)  1 1/29 (3.45%)  1 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 3/33 (9.09%)  4 4/33 (12.12%)  5 2/32 (6.25%)  2 0/29 (0.00%)  0 1/30 (3.33%)  1 1/30 (3.33%)  1 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Diarrhoea  1  3/25 (12.00%)  3 5/28 (17.86%)  5 1/12 (8.33%)  1 5/30 (16.67%)  5 2/33 (6.06%)  2 4/31 (12.90%)  5 1/31 (3.23%)  1 2/29 (6.90%)  2 4/32 (12.50%)  4 1/31 (3.23%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 3/33 (9.09%)  3 7/32 (21.88%)  7 1/29 (3.45%)  1 0/30 (0.00%)  0 1/30 (3.33%)  1 2/31 (6.45%)  3 1/20 (5.00%)  1 0/21 (0.00%)  0
Dry mouth  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 1/30 (3.33%)  1 1/33 (3.03%)  1 1/31 (3.23%)  1 1/31 (3.23%)  1 1/29 (3.45%)  1 1/32 (3.13%)  1 1/31 (3.23%)  1 1/32 (3.13%)  1 0/33 (0.00%)  0 2/33 (6.06%)  2 1/32 (3.13%)  1 1/29 (3.45%)  1 0/30 (0.00%)  0 2/30 (6.67%)  2 0/31 (0.00%)  0 1/20 (5.00%)  1 1/21 (4.76%)  1
Dyspepsia  1  3/25 (12.00%)  4 2/28 (7.14%)  2 0/12 (0.00%)  0 1/30 (3.33%)  1 1/33 (3.03%)  1 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 1/32 (3.13%)  1 1/33 (3.03%)  1 3/33 (9.09%)  3 1/32 (3.13%)  1 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 1/31 (3.23%)  1 0/20 (0.00%)  0 3/21 (14.29%)  3
Flatulence  1  1/25 (4.00%)  1 1/28 (3.57%)  1 0/12 (0.00%)  0 0/30 (0.00%)  0 2/33 (6.06%)  2 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 1/32 (3.13%)  1 1/31 (3.23%)  1 0/32 (0.00%)  0 1/33 (3.03%)  1 1/33 (3.03%)  1 1/32 (3.13%)  1 1/29 (3.45%)  1 0/30 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Frequent bowel movements  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 2/32 (6.25%)  2 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Gastrooesophageal reflux disease  1  1/25 (4.00%)  1 0/28 (0.00%)  0 0/12 (0.00%)  0 1/30 (3.33%)  1 0/33 (0.00%)  0 1/31 (3.23%)  1 2/31 (6.45%)  2 0/29 (0.00%)  0 2/32 (6.25%)  2 1/31 (3.23%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 1/33 (3.03%)  1 1/32 (3.13%)  1 0/29 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 1/20 (5.00%)  1 1/21 (4.76%)  1
Nausea  1  5/25 (20.00%)  5 7/28 (25.00%)  7 2/12 (16.67%)  2 8/30 (26.67%)  8 6/33 (18.18%)  6 5/31 (16.13%)  5 4/31 (12.90%)  4 0/29 (0.00%)  0 4/32 (12.50%)  5 4/31 (12.90%)  5 4/32 (12.50%)  4 2/33 (6.06%)  2 5/33 (15.15%)  6 1/32 (3.13%)  1 0/29 (0.00%)  0 1/30 (3.33%)  1 6/30 (20.00%)  6 3/31 (9.68%)  3 3/20 (15.00%)  3 6/21 (28.57%)  7
Tooth impacted  1  0/25 (0.00%)  0 0/28 (0.00%)  0 1/12 (8.33%)  1 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Vomiting  1  2/25 (8.00%)  2 4/28 (14.29%)  5 0/12 (0.00%)  0 2/30 (6.67%)  2 2/33 (6.06%)  2 1/31 (3.23%)  1 2/31 (6.45%)  2 2/29 (6.90%)  2 3/32 (9.38%)  5 2/31 (6.45%)  2 0/32 (0.00%)  0 2/33 (6.06%)  3 3/33 (9.09%)  3 0/32 (0.00%)  0 0/29 (0.00%)  0 1/30 (3.33%)  1 1/30 (3.33%)  1 0/31 (0.00%)  0 0/20 (0.00%)  0 3/21 (14.29%)  3
General disorders                                         
Asthenia  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 1/30 (3.33%)  1 3/33 (9.09%)  3 3/31 (9.68%)  3 2/31 (6.45%)  2 1/29 (3.45%)  1 5/32 (15.63%)  6 2/31 (6.45%)  2 7/32 (21.88%)  7 5/33 (15.15%)  7 6/33 (18.18%)  6 7/32 (21.88%)  7 4/29 (13.79%)  5 1/30 (3.33%)  1 1/30 (3.33%)  1 2/31 (6.45%)  2 2/20 (10.00%)  2 3/21 (14.29%)  3
Chills  1  1/25 (4.00%)  1 0/28 (0.00%)  0 0/12 (0.00%)  0 1/30 (3.33%)  1 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 2/32 (6.25%)  3 2/31 (6.45%)  2 0/32 (0.00%)  0 1/33 (3.03%)  1 1/33 (3.03%)  1 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 1/31 (3.23%)  2 0/20 (0.00%)  0 0/21 (0.00%)  0
Fatigue  1  9/25 (36.00%)  9 5/28 (17.86%)  5 4/12 (33.33%)  4 15/30 (50.00%)  15 10/33 (30.30%)  10 6/31 (19.35%)  7 11/31 (35.48%)  11 6/29 (20.69%)  6 9/32 (28.13%)  10 6/31 (19.35%)  7 6/32 (18.75%)  6 10/33 (30.30%)  12 15/33 (45.45%)  16 8/32 (25.00%)  8 2/29 (6.90%)  2 2/30 (6.67%)  2 11/30 (36.67%)  11 3/31 (9.68%)  3 2/20 (10.00%)  2 3/21 (14.29%)  3
Influenza like illness  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 1/32 (3.13%)  1 0/31 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 2/33 (6.06%)  2 1/32 (3.13%)  1 1/29 (3.45%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Malaise  1  2/25 (8.00%)  2 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 1/32 (3.13%)  1 0/31 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 1/33 (3.03%)  1 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Oedema peripheral  1  0/25 (0.00%)  0 0/28 (0.00%)  0 1/12 (8.33%)  1 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 1/29 (3.45%)  1 0/32 (0.00%)  0 1/31 (3.23%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Pain  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1 0/29 (0.00%)  0 1/32 (3.13%)  1 0/31 (0.00%)  0 1/32 (3.13%)  1 1/33 (3.03%)  1 0/33 (0.00%)  0 2/32 (6.25%)  2 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1
Peripheral swelling  1  0/25 (0.00%)  0 0/28 (0.00%)  0 1/12 (8.33%)  1 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 1/29 (3.45%)  1 1/32 (3.13%)  1 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Hepatobiliary disorders                                         
Hyperbilirubinaemia  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 1/30 (3.33%)  1 2/33 (6.06%)  2 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 1/32 (3.13%)  1 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Infections and infestations                                         
Bronchitis  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 2/30 (6.67%)  2 0/33 (0.00%)  0 0/31 (0.00%)  0 1/31 (3.23%)  1 0/29 (0.00%)  0 2/32 (6.25%)  2 1/31 (3.23%)  2 0/32 (0.00%)  0 1/33 (3.03%)  1 4/33 (12.12%)  4 0/32 (0.00%)  0 1/29 (3.45%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Ear infection  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 1/32 (3.13%)  1 2/31 (6.45%)  2 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Gastroenteritis  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 1/31 (3.23%)  1 1/31 (3.23%)  1 0/29 (0.00%)  0 2/32 (6.25%)  2 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 1/33 (3.03%)  1 1/32 (3.13%)  1 0/29 (0.00%)  0 0/30 (0.00%)  0 1/30 (3.33%)  1 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Influenza  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 1/31 (3.23%)  1 1/31 (3.23%)  1 1/29 (3.45%)  1 0/32 (0.00%)  0 0/31 (0.00%)  0 1/32 (3.13%)  1 2/33 (6.06%)  2 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 1/21 (4.76%)  1
Nasopharyngitis  1  2/25 (8.00%)  2 0/28 (0.00%)  0 0/12 (0.00%)  0 1/30 (3.33%)  1 3/33 (9.09%)  3 1/31 (3.23%)  1 2/31 (6.45%)  2 0/29 (0.00%)  0 0/32 (0.00%)  0 4/31 (12.90%)  5 3/32 (9.38%)  3 1/33 (3.03%)  1 5/33 (15.15%)  6 0/32 (0.00%)  0 1/29 (3.45%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Oral herpes  1  1/25 (4.00%)  1 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 1/33 (3.03%)  1 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 1/32 (3.13%)  1 0/31 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 2/21 (9.52%)  2
Sinusitis  1  0/25 (0.00%)  0 3/28 (10.71%)  3 0/12 (0.00%)  0 1/30 (3.33%)  1 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/33 (6.06%)  2 0/32 (0.00%)  0 2/29 (6.90%)  2 0/30 (0.00%)  0 0/30 (0.00%)  0 2/31 (6.45%)  2 0/20 (0.00%)  0 0/21 (0.00%)  0
Upper respiratory tract infection  1  2/25 (8.00%)  2 1/28 (3.57%)  1 0/12 (0.00%)  0 3/30 (10.00%)  3 1/33 (3.03%)  1 0/31 (0.00%)  0 0/31 (0.00%)  0 2/29 (6.90%)  2 3/32 (9.38%)  3 1/31 (3.23%)  1 0/32 (0.00%)  0 1/33 (3.03%)  1 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/31 (0.00%)  0 3/20 (15.00%)  3 5/21 (23.81%)  5
Urinary tract infection  1  1/25 (4.00%)  1 2/28 (7.14%)  2 0/12 (0.00%)  0 1/30 (3.33%)  1 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 1/29 (3.45%)  3 0/32 (0.00%)  0 1/31 (3.23%)  1 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Injury, poisoning and procedural complications                                         
Accidental overdose  1  1/25 (4.00%)  1 1/28 (3.57%)  1 1/12 (8.33%)  1 3/30 (10.00%)  3 4/33 (12.12%)  5 0/31 (0.00%)  0 5/31 (16.13%)  6 0/29 (0.00%)  0 3/32 (9.38%)  3 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 2/33 (6.06%)  5 0/32 (0.00%)  0 1/29 (3.45%)  1 0/30 (0.00%)  0 2/30 (6.67%)  2 0/31 (0.00%)  0 3/20 (15.00%)  4 2/21 (9.52%)  4
Arthropod sting  1  0/25 (0.00%)  0 0/28 (0.00%)  0 1/12 (8.33%)  1 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Contusion  1  0/25 (0.00%)  0 0/28 (0.00%)  0 1/12 (8.33%)  1 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Investigations                                         
Alanine aminotransferase increased  1  0/25 (0.00%)  0 2/28 (7.14%)  2 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Amylase increased  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 2/29 (6.90%)  2 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Aspartate aminotransferase increased  1  0/25 (0.00%)  0 2/28 (7.14%)  2 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Blood creatine phosphokinase increased  1  0/25 (0.00%)  0 0/28 (0.00%)  0 1/12 (8.33%)  1 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 1/32 (3.13%)  1 0/33 (0.00%)  0 0/33 (0.00%)  0 1/32 (3.13%)  1 1/29 (3.45%)  1 0/30 (0.00%)  0 1/30 (3.33%)  1 1/31 (3.23%)  1 0/20 (0.00%)  0 1/21 (4.76%)  1
International normalised ratio increased  1  3/25 (12.00%)  8 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 2/33 (6.06%)  2 0/31 (0.00%)  0 0/31 (0.00%)  0 0/29 (0.00%)  0 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0 0/32 (0.00%)  0 0/29 (0.00%)  0 0/30 (0.00%)  0 0/30 (0.00%)  0 0/31 (0.00%)  0 0/20 (0.00%)  0 0/21 (0.00%)  0
Lipase increased  1  0/25 (0.00%)  0 0/28 (0.00%)  0 0/12 (0.00%)  0 0/30 (0.00%)  0 0/33 (0.00%)  0 0/31 (0.00%)  0 0/31 (0.00%)  0 2/29 (6.90%)  2 0/32 (0.00%)  0 0/31 (0.00%)  0 0/32 (0.00%)  0 0/33 (0.00%)  0 0/33 (0.00%)  0