TMC435-TiDP16-C215 A Study of TMC435 in Patients With Chronic Hepatitis C

• Decrease in plasma HCV RNA level. [ Time Frame: Week 4 of treatment. ] [ Designated as safety issue: No ]
  

• Proportion of patients with undetectable HCV RNA [ Time Frame: Week 4, 12, 24, EOT and at follow-up Week 12 and 24 ] [ Designated as safety issue: No ]
  
• Proportion of patients with at least 2 log10 decrease in HCV RNA [ Time Frame: All vist over 72-week period ] [ Designated as safety issue: No ]
  
• Adverse Events monitoring [ Time Frame: Continuously over 72-week period ] [ Designated as safety issue: No ]
  
• Pharmacokinetics and pharmacokinetics/pharmacodynamic relationship of TMC435 [ Time Frame: Week 2, 4, 8, 12, 16 and 24 ] [ Designated as safety issue: No ]
  

This is a randomized (study drug assigned by chance), 5-arm open-label study to evaluate the efficacy, safety and pharmacokinetics different TMC435 regimens combined with the standard of care (SoC: peginterferon alfa-2a and ribavirin) versus SoC alone in Japanese adult treatment-naïve patients (never received treatment for HCV) with chronic genotype 1 hepatitis C virus (HCV) infection. Depending on the treatment arm, patients will receive TMC435 (50 or 100 mg) for a duration of 12 or 24 weeks. In treatment arms 1 and 2, subjects will receive 12 weeks of triple therapy with TMC435 once daily plus SoC followed by 12 weeks of treatment with SoC. In treatment arms 3 and 4, patients will receive 24 weeks of triple therapy with TMC435 once daily plus SoC. In treatment arm 5 (control group), patients will be treated with SoC treatment for 48 weeks. The study's objective is to evaluate and compare the efficacy of the treatment arms including TMC435 vs the SoC arm by measuring the decrease in HCV RNA levels. TMC435 is a 50mg or 100mg capsule and will be taken orally (via the mouth). Depending on the treatment arm patients will receive TMC435 for a duration of 12 or 24 weeks. The Standard of Care (SoC) treatment will last 24 or 48 weeks: Pegylated interferon is supplied as a vial containing 1.0 mL solution with 180 µg pegINFalpha-2a, then it will be injected by a syringe under the skin once weekly. Ribavirin is given as 200 mg tablets (daily dose: 600-1000mg), and taken orally two times a day with food. The patients will receive oral capsule of TMC435 (either 50 or 100 mg) once daily for up to Week 12 or 24.