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

Phase 3CompletedNCT02252016

Merck Sharp & Dohme LLC159 enrolled

Overview

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%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

159

Conditions

Hepatitis C

Interventions

Grazoprevir + ElbasvirDRUG

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.

PlaceboDRUG

Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After Completing Study Therapy (SVR12)

The percentage of participants in the both arms achieving SVR12 (i.e., HCV riboncleic acid \[RNA\] level below the lower limit of quantification \[LLoQ\] 12 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of \<15 IU/mL.

Time frame: 12 weeks after completing study therapy (Week 24)

Percentage of Participants Experiencing an Adverse Event (AE)

An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.

Time frame: Up to Week 14

Percentage of Participants Discontinuing From Study Treatment Due to an AE(s)

An AE is any untoward medical occurrence which does not necessarily have to have a causal relationship with this treatment.

Time frame: Up to Week 12

Secondary Outcomes

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completing Study Therapy (SVR24)

The percentage of participants in both arms achieving SVR24 (i.e., HCV RNA level below the LLoQ 24 weeks after completing study therapy) was determined. HCV RNA levels were measured using the Roche COBAS™ Taqman™ HCV Test v2.0 (High Pure System), which has a LLoQ of \<15 IU/mL.

Time frame: 24 weeks after completing study therapy (Week 36)

Data from ClinicalTrials.gov

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