Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Placebo; Drug: Grazoprevir + Elbasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02252016

5172-065

2014-002356-27 (EudraCT Number)

Details and patient eligibility

About

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%.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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159 participants in 2 patient groups, including a placebo group

Immediate Treatment

Experimental group

Description:

Participants will take grazoprevir 100 mg + elbasvir 50 mg once daily during the 12-week treatment period and then will be monitored for safety during a 24-week follow-up period.

Treatment:

Drug: Grazoprevir + Elbasvir

Deferred Treatment

Placebo Comparator group

Description:

Participants will take placebo tablets once daily during the 12-week treatment period and will then be monitored for safety during a 4-week follow-up period. Participants will then begin open-label treatment with grazoprevir 100 mg + elbasvir 50 mg for a 12-week treatment period and will then be monitored for safety during a 24-week follow-up period.

Treatment:

Drug: Placebo

Drug: Grazoprevir + Elbasvir