Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045)
Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir
 (300 mg twice daily) given in combination with pegylated interferon alfa-2b (peg-IFN) and
 ribavirin (RBV) in Japanese participants with chronic hepatitis C (CHC) genotype (GT) 1 who
 have not responded to previous treatment. The primary efficacy objective is to estimate
 efficacy of vaniprevir, peg-IFN and RBV for 24 weeks as assessed by the percentage of
 participants achieving undetectable Hepatitis C Virus ribonucleic acid (HCV RNA) 24 weeks
 after completion of all study therapy (Sustained Viral Response 24 [SVR24]).
Inclusion criteria:

 -  Japanese participant diagnosed with compensated CHC GT 1

 -  Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other
 signs or symptoms of advanced liver disease

 -  Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN)
 with or without use of ribavirin, but failed to respond to the prior treatment
 (partial responder or null responder)

 -  No evidence of cirrhosis

 Exclusion criteria:

 -  Co-infection with human immunodeficiency virus (HIV)

 -  Positive hepatitis B surface antigen or other evidence of active hepatitis B infection

 -  Any other condition that is contraindicated or for which caution is required for
 treatment with peg-IFN or RBV

 -  Any condition or pre-study laboratory abnormality, or history of any illness, that, in
 the opinion of the investigator, might confound the results of the study or pose
 additional risk in administering the study drugs, peg-IFN and RBV, to the participant