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)

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Grazoprevir; Sofosbuvir

Criteria

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