Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)

A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly With Pegylated Interferon and Ribavirin in Treatment-Experienced Patients With Chronic Genotype 1 Hepatitis C Virus Infection

The purpose of this study is to test the safety, tolerability, and efficacy of 4 regimens of Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC) participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of study therapy (SVR24).

Inclusion criteria:

• Has chronic HCV genotype 1 infection
• Is treatment-experienced
• For the non-cirrhotic population, has had a liver biopsy without evidence of cirrhosis and hepatocellular carcinoma; for the cirrhotic population, has had a liver biopsy with evidence of cirrhosis and without evidence of hepatocellular carcinoma.

Exclusion criteria:

• Has not tolerated previous course peg-IFN and RBV
• Is unlikely to tolerate at least 24 weeks of continuous therapy with Peg-IFN and RBV
• Is co-infected with Human Immunodeficiency Virus (HIV) and/or hepatitis B
• Consumes excessive amounts of alcohol
• Has a history of drug or alcohol abuse
• If female, participant is pregnant or breastfeeding
• Has been in a clinical trail with an investigational drug in the last 30 days
• Has used IFN/Peg-IFN and RBV in the last 3 months