Phase 3
N=159
Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT02252016 ↗Enrolled (actual)
159
Serious AEs
7.6%
Results posted
Jan 2017
Primary outcome: Primary: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) — 93.5; 91.8 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Grazoprevir + Elbasvir (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12) |
93.5; 91.8 | — |
| PRIMARY Percentage of Participants Experiencing an Adverse Event (AE) |
72.9; 65.4 | — |
| PRIMARY Percentage of Participants Discontinuing From Study Treatment Due to an AE(s) |
0.0; 1.9 | 0.155 |
| SECONDARY Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24) |
90.7; 91.8 | — |
Summary
This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC) of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy (SVR12) will be greater than the reference rate of 40%.
Eligibility Criteria
Inclusion Criteria
- has HCV GT1, GT4, or GT6 with sickle cell anemia, thalassemia, or hemophilia/von Willebrand disease
- has cirrhosis or is non-cirrhotic
- is human immunodeficiency virus (HIV) coinfected or not infected with HIV
- is a female of non childbearing potential, or is male or female and uses an acceptable method(s) of contraception
Exclusion Criteria
- has evidence of decompensated liver disease
- is coinfected with hepatitis B
- has had a malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- has hepatocellular carcinoma (HCC) or is under evaluation for HCC
- has clinically-relevant drug or alcohol abuse within 12 months of screening
Data sourced from ClinicalTrials.gov (NCT02252016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.