An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients
An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients
The purpose of this study is to provide confirmatory efficacy and safety data of TMC435 as
 part of a treatment regimen including peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) in
 patients with genotype 1 Hepatitis C virus (HCV) infection.
This is a multicenter, randomized (study drug is assigned by chance), double-blind (neither
 sponsor, physician nor patient knows the name of the assigned study drug), Phase III study to
 compare the efficacy, tolerability and safety of TMC435 (in development for treatment of
 chronic hepatitis C virus [HCV] infection) versus placebo (a preparation containing no drug
 used as control) as part of a treatment regimen including peginterferon-alpha (PegIFNα-2a)
 and ribavirin (RBV) (both current therapies for HCV) in adult treatment-naïve patients
 (patients who have never taken HCV medications) with genotype 1 Hepatitis C virus (HCV)
 infection. The study will consist of a screening period with a maximum duration of 6 weeks, a
 response guided 24- or 48-week (TMC435 treatment groups) or 48-week (control group) treatment
 period, and a post-therapy follow-up period up to 72 weeks after the start of treatment.
 Patients will be randomly assigned in a 1:1:1 fashion to receive TMC435 or placebo,
 stratified by HCV genotype 1 subtype and IL28B genotype within each country. In the first 24
 weeks, patients will receive 12 weeks TMC435 100 or 150 mg or placebo once-daily (q.d.) plus
 PegIFNα-2a plus RBV, after which they will continue with PegIFNα-2a and RBV. Response-guided
 treatment criteria will be used to determine PegIFNα-2a and RBV total treatment duration of
 24 or 48 weeks for patients in the TMC435 treatment groups. In the control group, all
 patients will be required to complete 48 weeks of treatment with PegIFNα-2a and RBV. In all 3
 treatment groups, there will be a post-therapy follow-up period up to 72 weeks after the
 start of treatment. The total study duration for each patient will be a maximum of 78 weeks
 (including the 6-week screening period).
Inclusion Criteria:

 -  A liver biopsy within 3 years prior to the screening visit (or between screening and
 day of randomization) with histology consistent with chronic Hepatitis C virus (HCV)
 infection

 -  Presence of contraindications for a liver biopsy in patients who are otherwise deemed
 eligible for participation does not exclude the patient from participation

 -  Genotype 1 HCV infection (confirmed at screening)

 -  Plasma HCV RNA of > 10,000 IU/mL at screening

 Exclusion Criteria:

 -  Prior treatment with any approved or investigational drug for the treatment of
 hepatitis C

 -  Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)