VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection
Condition: Genotype 1 Chronic Hepatitis C; Treatment Naive
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic
Intervention: Ribavirin; Telaprevir; Pegylated interferon alfa-2a; Telaprevir
Intervention description: Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4; 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks; 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4; 750 mg (2 oral tablets) every 8 hours for 12 weeks
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: 744.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Genotype 1 chronic hepatitis C; VX-950-C211; VX-950; IL28B; Telaprevir; Hepatitis C; BID; Q8h; SOC

Summary:

      The purpose of this study is to evaluate the effectiveness of telaprevir administered twice
      daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in
      treatment-naïve participants with chronic HCV genotype 1 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL

          -  Patients should not have had any previous treatment for hepatitis C

          -  Patient must have documentation of a liver biopsy within 2 years before the screening
             visit or the patient must agree to have a biopsy performed within the screening period

          -  Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP
             > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening
             period

          -  A female patient of childbearing potential and a nonvasectomized male patient who has
             a female partner of childbearing potential must agree to the use of 2 effective
             methods of birth control from screening until 6 months (female patient) or 7 months
             (male patient) after the last dose of RBV.

        Exclusion Criteria:

          -  Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or
             patient is infected with more than one genotype subtype

          -  Patient has a pre-existing psychiatric condition

          -  Patient has history of decompensated liver disease or shows evidence of significant
             liver disease in addition to hepatitis C

          -  Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection

          -  Patient has active malignant disease or history of malignant disease within the past 5
             years (with the exception of treated basal cell carcinoma).