A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
The purpose of this study is to evaluate the efficacy, tolerability, and safety of 12-weeks
 of treatment with TMC435 plus pegylated interferon alfa-2a (PegIFNα-2a) and ribavirin (RBV)
 in previously untreated adult participants with genotype 1 or genotype 4 chronic Hepatitis C
 Virus (HCV) infection.
This is a multicenter, international study where all participants will receive triple therapy
 with the following 3 medications: TMC435 also referred to as simeprevir (formerly known as
 TMC435350) which is an investigational medication in development for the treatment of chronic
 hepatitis C virus (HCV) infection, pegylated interferon alfa-2a (PegIFNα-2a), and ribavirin
 (RBV). PegIFNα-2a and RBV are commercially available therapies for HCV infection.
 Participants will receive treatment with TMC435, PegIFNα-2a, and RBV for 12 weeks. If blood
 levels of HCV ribonucleic acid (RNA) monitored at Weeks 2, 4, and 8 are below 25 IU/mL, all
 treatment will be stopped at Week 12. If HCV RNA values are above 25 IU/mL at Weeks 2, 4, or
 8, treatment with PegIFNα-2a and RBV will continue for an additional 12 weeks (up to Week 24)
 unless protocol-specified stopping criteria are met at Week 4 or 12, at which time all
 treatment will be discontinued. The study will be conducted in 3 phases: a screening phase of
 maximum 6 weeks, a treatment phase extending from Day 1 (baseline) up to 12 or 24 weeks
 depending on the response to treatment, and a posttreatment follow-up period of 24 weeks
 after the participant's last planned dose of study drug. The duration of the participation
 (excluding screening phase) for each participant will vary between 36 and 48 weeks, depending
 on the response to treatment. Blood samples for laboratory analysis will be obtained from
 participants at protocol-specified time points during the study and participant safety will
 be monitored throughout the study.
Inclusion Criteria:

 -  treatment-naïve with confirmed chronic Hepatitis C Virus (HCV) infection

 -  liver biopsy performed within 2 years prior to screening or non-invasive confirmation
 of the liver disease stage (by transient elastography) performed within 6 months prior
 to screening

 -  liver disease stage equivalent to Metavir Score F0-F2 (no fibrosis, or portal fibrosis
 without or with few septa)

 Exclusion Criteria:

 -Participants with advanced liver disease equivalent to Metavir score F3-F4 (bridging
 fibrosis or cirrhosis), with hepatic decompensation, with any liver disease of non-HCV
 etiology, and/or with a non-genotype 1 or non-genotype 4 hepatitis C, hepatitis B or HIV
 co-infection will be excluded from the study