Efficacy of a 12-week Regimen of Telaprevir, Peginterferon, and Ribavirin in Subjects With Interleukin-28B (IL28B) CC Genotype in Treatment-naive and Prior Relapser Subjects

Inclusion Criteria:

- Male and female subjects, 18 to 70 years of age, inclusive

- Treatment-naive OR subjects (prior relapsers) may be included who did not achieve
SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and
had a documented undetectable HCV RNA level at the planned end of treatment of at
least 42-week duration

- Subjects have IL28B CC genotype determined during screening

- Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection
for at least 6 months, defined by (1) documented HCV serology test at least 6 months
before the first screening visit demonstrating the presence of anti-HCV antibody, or
(2) documented presence of HCV RNA by a sensitive and specific assay at least 6
months before the first screening visit, or (3) documented histologic evidence of
chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading
system at least 6 months before the first screening visit. If only inflammation is
present in the liver histologic report, then 6 months of laboratory evidence is
required.

Exclusion Criteria:

- Subjects have received previous treatment with telaprevir or any other protease
inhibitor(s) for chronic hepatitis C.

- Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV
therapy of standard duration and never achieved undetectable HCV RNA while on
treatment

- Subjects have evidence of hepatic decompensation

- Subjects have evidence of cirrhosis

- Subjects have diagnosed or suspected hepatocellular carcinoma

- Subjects have any other cause of significant liver disease in addition to hepatitis
C, which may include but is not limited to malignancy with hepatic involvement,
hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis,
hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary
cirrhosis. Steatosis is allowed if clinically asymptomatic