A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)

An Open Label Study Assessing SVR and Viral Resistance Profile With Boceprevir Plus PEG-IFN Plus Ribavirin Triple Therapy in HCV-1 Infected Patients With Insulin Resistance Who Have Failed PEG-IFN Plus Ribavirin Dual Therapy

This study is being done to find out if participants with insulin resistance and hepatitis C virus genotype 1 (HCV GT1) infections who failed dual therapy with peginterferon alfa (PegIFN) + ribavirin (RBV) will benefit from the addition of boceprevir to PegIFN + RBV (triple therapy).

Inclusion criteria:

• Quantifiable serum hepatitis C virus-ribonucleic acid (HCV-RNA)
• Hepatitis C virus genotype 1
• Homeostasis Model of Assessment - Insulin Resistance (HOMA IR) > 2.5 in two determinations made 4 weeks apart (the first HOMA evaluation is able to be made 3 weeks before screening visit)
• Previous failure to achieve SVR with PegIFN plus ribavirin given for a minimum of 12 weeks without dose reduction below 80% of the adequate doses of the two drugs
• No response, partial response, or relapse after previous therapy
• Compensated liver disease with or without histologic or non-invasive evidence of liver cirrhosis
• If heterosexually active, a female participant of childbearing potential and a non-vasectomized male participant who has a female partner of childbearing potential must agree to use 2 effective contraceptives until 6 months after therapy has ended (7 months for male subject)

Exclusion criteria:

• Coinfection with HCV genotypes other than HCV-GT1
• Evidence of decompensated liver disease
• History of ascites, hepatic encephalopathy or of bleeding varices or severe portal hypertension
• History or signs or symptoms or evidence of hepatocellular carcinoma (HCC)
• History of organ transplant
• Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
• Severe psychiatric disease
• Inadequately controlled thyroid function
• Other important comorbidities (cardiovascular diseases, Type 1 diabetes or inadequately controlled type 2 diabetes, malignancies , etc)
• Substances abuse
• Alcohol intake >20 grams/day for females and >30 grams/day for males
• History of severe adverse events during previous treatment with PegIFN plus ribavirin including discontinuation of therapy for severe anemia or hematologic toxicity