Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)
Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir
 given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus
 treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic
 hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of
 participants achieving sustained virologic response 24 weeks after completion of all study
 therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of
 participants achieving SVR24 in the control arm.
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.

 -  IFN treatment naive

 -  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.