Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Telaprevir; Pegylated Interferon Alfa-2a; Ribavirin
Intervention description: Tablet; Subcutaneous Injection; Tablet
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: VX-950; INCIVEK; INCIVO

Summary:

      The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in
      combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV)
      (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC
      genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV)
      infection and will not have cirrhosis of the liver.
    

Eligibility criteria:

        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
             sustained viral response 24 weeks after last planned dose of study drug (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