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Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077)

Last Updated: 2018-10-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-27

Study Completion Date

2016-02-16

Brief Summary

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This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) \[PR\] treatment in treatment-naïve and prior PR treatment failure participants with chronic Hepatitis C Virus (HCV) genotype (GT)1, GT4, or GT6 infection. The primary objectives are to compare efficacy (assessed by the percentage of participants achieving sustained virologic response 12 weeks after ending study treatment \[SVR12\]) and safety between the grazoprevir plus elbasvir treatment arm and the SOF plus PR treatment arm. The primary hypothesis is that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir treatment arm is non-inferior to that in the SOF plus PR treatment arm.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Grazoprevir + Elbasvir

Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.

Group Type EXPERIMENTAL

Sofosbuvir

Intervention Type DRUG

400 mg tablets, taken orally (PO) every day (QD) for 12 weeks.

PegIntron

Intervention Type BIOLOGICAL

PegIntron administered subcutaneously every week (QW) at 1.5 mcg/kg for 12 weeks.

Ribavirin

Intervention Type DRUG

Capsule and/or tablet administered PO twice daily (BID) based on weight (1000 - 1200 mg) for 12 weeks.

SOF + PR

Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.

Group Type ACTIVE_COMPARATOR

Grazoprevir/Elbasvir (100 mg/50 mg) FDC

Intervention Type DRUG

Grazoprevir/Elbasvir (100 mg/50 mg) FDC, taken PO QD for 12 weeks.

Interventions

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Sofosbuvir

400 mg tablets, taken orally (PO) every day (QD) for 12 weeks.

Intervention Type DRUG

PegIntron

PegIntron administered subcutaneously every week (QW) at 1.5 mcg/kg for 12 weeks.

Intervention Type BIOLOGICAL

Ribavirin

Capsule and/or tablet administered PO twice daily (BID) based on weight (1000 - 1200 mg) for 12 weeks.

Intervention Type DRUG

Grazoprevir/Elbasvir (100 mg/50 mg) FDC

Grazoprevir/Elbasvir (100 mg/50 mg) FDC, taken PO QD for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Weigh ≥40 kg and ≤125 kg
* documented chronic HCV GT1, GT4, or GT6 infection
* cirrhosis/absence of cirrhosis defined by liver biopsy, Fibroscan, or FibroSure®
* either treatment naïve or PR Null Responder, PR Partial Responder, or PR Prior Relapser
* participant and partner both agree to use at least use at least 2 effective methods of contraception from at least 2 weeks prior to Day 1 and continue until up to 6 months after last dose of study drug, or longer if dictated by local regulations

Exclusion Criteria

* has evidence of decompensated liver disease
* is coinfected with hepatitis B virus (e.g. hepatitis B surface antigen positive) or human immunodeficiency virus
* history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
* has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
* has any of the following conditions: immunologically-mediated disease, organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial, history of chronic hepatitis not caused by HCV

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers