• The proportion of patients with undetectable HCV RNA [ Time Frame: 24 weeks after the planned end of treatment ] [ Designated as safety issue: No ]
  

• Proportion of patients with rapid virologic response (RVR) [ Time Frame: at Week 4 ] [ Designated as safety issue: No ]
  
• Proportion of patients with early virologic response (EVR) and complete early virologic response (cEVR) [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]
  
• Proportion of patients with undetectable HCV-RNA (SVR 12) [ Time Frame: at Week 60 ] [ Designated as safety issue: No ]
  
• Changes in HCV RNA levels over time [ Time Frame: 20 visits over 72-week period ] [ Designated as safety issue: No ]
  
• PK/PD relationship of TMC435 [ Time Frame: at Week 2, 4, 8, 12, 16, 24 and 48 ] [ Designated as safety issue: No ]
  

The study is a randomized (study drug assigned by chance), double-blind (neither physician nor patient knows the name of the assigned drug), placebo-controlled Phase IIb trial with TMC435 in patients with chronic, genotype 1, hepatitis C who have failed standard treatment with pegylated interferon (Peg-INF) and ribavirin (RBV). The study will compare the efficacy, tolerability and safety of different regimens with TMC435 combined with standard treatment (Peg-INF and RBV) versus standard treatment alone. The trial will consist of a screening period of maximum 6 weeks, a 48-week treatment period, and a 24-week follow-up period. Patients will be eligible to enroll in the trial if they failed to respond to a prior course of standard treatment or relapsed following standard treatment. Treatment arms 1 and 2 will receive TMC435 with standard treatment for 12 weeks; followed by standard treatment (plus placebo) for 36 weeks. Treatment arms 3 and 4 will receive TMC435 (100 mg or 150 mg once a day) with standard treatment for 24 weeks; followed by standard treatment (plus placebo) for 24 weeks. Treatment arms 5 and 6 will receive TMC435 (100 mg or 150 mg once a day) with standard treatment for 48 weeks. Treatment arm 7 (control arm) will receive standard treatment for 48 weeks. TMC435 (either 100 mg or 150 mg) will be given by mouth once a day for either 12, 24 or 48 weeks. Placebo will be given by mouth once a day for either 24, 36 or 48 weeks. Peg-INF will be given as an injection under the skin at a dose of 180 mcg once every week for 48 weeks. RBV (either 1000 or 1200 mg, depending on your body weight) will be given by mouth twice a day for 48 weeks.