A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: TMC435; PSI-7977 (GS7977); Ribavirin
Intervention description: TMC435 will be administered as one oral capsule of 150 mg once a day.; PSI-7977 (GS7977) will be administered as oral tablets (2 tablets of 200 mg for Cohort 1 and 1 tablet of 400 mg for Cohort 2) once a day.; Ribavirin will be administered according to body weight. For patients with body weight less than 75 kg daily dose (1000 mg) will be administered as 400 mg (2 oral tablets of 200 mg) in the morning and 600 mg (3 oral tablets of 200 mg) in the evening. Body weight more than or equal to 75 kg daily dose (1200 mg) will be administered as 600 mg twice a day (3 tablets of 200 mg per intake, morning and evening).
Intervention MeSH terms: Ribavirin; Sofosbuvir; Simeprevir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 168.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Hepatitis C; TMC435; PSI-7977; GS7977; Ribavirin; HCV; Hep C; Genotype 1

Summary:

      The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977
      (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1
      hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or
      are HCV treatment-naive (patients who never received treatment for HCV infection).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic genotype 1 hepatitis C virus (HCV) infection

          -  Plasma HCV RNA of more than 10,000 IU/mL at screening

          -  Patients in Cohort 1 must be null responders to PegIFN/ribavirin with at least 1
             documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive
             weeks

          -  Patients in Cohort 2 must be null responders to PegIFN/ribavirin with at least 1
             documented previous course of PegIFN/ribavirin therapy for at least 12 consecutive
             weeks and could also be HCV treatment-naive, meaning never received treatment with any
             approved or investigational drug for the treatment of HCV

          -  Null responders patients in Cohort 1 and Cohort 2 must meet the defined criterion for
             a null responder, defined as on-treatment less than 2 log10 IU/mL reduction in HCV RNA
             from baseline at Week 12 of the most recent PegIFN/ribavirin therapy

          -  Patient must have had a liver biopsy within 3 years before screening (or between
             screening and baseline visit) or patient must have had a liver biopsy at any time in
             the past which showed Metavir F3 or F4 fibrosis

          -  Must agree to use 2 forms of effective contraception throughout the study (male and
             female)

        Exclusion Criteria:

          -  Has evidence of hepatic decompensation

          -  Has any liver disease of non-HCV etiology

          -  Has an infection/co-infection with non-genotype 1 HCV

          -  Has a co-infection with Human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or
             HIV-2) (positive HIV-1 or HIV-2 antibody test at screening)

          -  Has a co-infection with hepatitis B virus (hepatitis B surface antigen [HBsAg]
             positive)

          -  Has a history of malignancy within 5 years of the screening visit