Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-13

Study Completion Date

2016-02-01

Brief Summary

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This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The objective is to determine the proportion of participants achieving sustained virologic response 12 weeks after ending study treatment (SVR12).

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Detailed Description

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The study is an open-label, single-center, multiple-arm investigation of a fixed-dose combination \[FDC\] of grazoprevir 100mg + elbasvir 50mg, and SOF 400mg, in treatment-naive participants with chronic HCV GT1 or GT3. The impact of study treatment regimens of varying duration on SVR12 (undetectable HCV ribonucleic acid \[RNA\] 12 weeks after ending study treatment) in cirrhotic (C) participants and non-cirrhotic (NC) participants will be determined (Part A). Any HCV GT1 participant from study Arms 1-4 in Part A who experienced virologic relapse will be offered retreatment consisting of 12 additional weeks of treatment with MK-5172/MK-8742 + SOF + ribavirin and 24 weeks of follow-up in Part B.

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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GT1:NC Grazoprevir/Elbasvir+SOF 4wk

Participants took grazoprevir/elbasvir (100mg/50mg) FDC with SOF 400mg once daily (q.d.) by mouth for 4 weeks (n=30 planned).

Group Type EXPERIMENTAL

Grazoprevir/Elbasvir FDC

Intervention Type DRUG

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400mg tablet taken q.d. by mouth.

GT1:NC Grazoprevir/Elbasvir+SOF 6wk

Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=30 planned).

Group Type EXPERIMENTAL

Grazoprevir/Elbasvir FDC

Intervention Type DRUG

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400mg tablet taken q.d. by mouth.

GT1:C Grazoprevir/Elbasvir+SOF 6wk

Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=20 planned).

Group Type EXPERIMENTAL

Grazoprevir/Elbasvir FDC

Intervention Type DRUG

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400mg tablet taken q.d. by mouth.

GT1:C Grazoprevir/Elbasvir+SOF 8wk

Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=20 planned).

Group Type EXPERIMENTAL

Grazoprevir/Elbasvir FDC

Intervention Type DRUG

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400mg tablet taken q.d. by mouth.

GT3:NC Grazoprevir/Elbasvir+SOF 8wk

Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=15 planned).

Group Type EXPERIMENTAL

Grazoprevir/Elbasvir FDC

Intervention Type DRUG

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400mg tablet taken q.d. by mouth.

GT3:NC Grazoprevir/Elbasvir+SOF 12wk

Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=15 planned).

Group Type EXPERIMENTAL

Grazoprevir/Elbasvir FDC

Intervention Type DRUG

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400mg tablet taken q.d. by mouth.

GT3:C Grazoprevir/Elbasvir+SOF 12wk

Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=10 planned).

Group Type EXPERIMENTAL

Grazoprevir/Elbasvir FDC

Intervention Type DRUG

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.

Sofosbuvir

Intervention Type DRUG

Sofosbuvir 400mg tablet taken q.d. by mouth.

Interventions

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Grazoprevir/Elbasvir FDC

FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.

Intervention Type DRUG

Sofosbuvir

Sofosbuvir 400mg tablet taken q.d. by mouth.

Intervention Type DRUG

Other Intervention Names

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MK-5172A, Zepatier

Eligibility Criteria

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Inclusion Criteria

* has HCV RNA ≥10,000 IU/mL in peripheral blood at the time of screening
* has documented chronic HCV GT1 or GT3 infection
* has either negative or positive history of liver cirrhosis based on liver biopsy, Fibroscan, or FibroSure ® (Fibrotest®)
* is treatment naïve to all anti-HCV treatment

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
* has a 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 clinically-relevant drug or alcohol abuse within 12 months of screening
* has any of the following conditions: 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
* has a history of chronic hepatitis not caused by HCV

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No