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