TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy (ATTAIN)

• The proportion of patients with sustained virological response 12 weeks after the planned end of treatment (SVR12) [ Time Frame: At Week 60 ] [ Designated as safety issue: Yes ]

  Patients are considered to have reached SVR12 if both conditions below are met:

  1. at the actual end of treatment: HCV RNA levels < 25 IU/mL undetectable AND
  2. at the timepoint of SVR12 (i.e., 12 weeks after the planned end of treatment): HCV RNA levels < 25 IU/mL undetectable or HCV RNA levels < 25 IU/mL detectable
  
  

• The proportion of patients with sustained virological response 24 weeks after the planned end of treatment (SVR24) [ Time Frame: At Week 72 ] [ Designated as safety issue: Yes ]

  Patients are considered to have reached SVR24 if both conditions below are met:

  1. at the actual end of treatment: HCV RNA levels < 25 IU/mL undetectable AND
  2. at the timepoint of SVR24 (i.e., 24 weeks after the planned end of treatment): HCV RNA levels < 25 IU/mL undetectable or HCV RNA levels < 25 IU/mL detectable
  
  

This study is a randomized (study drug assigned by chance like flipping a coin), double-blind (neither physician nor patient knows the name of the assigned drug), double-dummy (patients receive both active and inactive pills also called placebo), 2-arm, multicenter Phase III clinical study in adult treatment experienced Chronic Hepatitis C (CHC) genotype-1 infected patients who failed to respond during at least 1 previous course of PegINFα-2a/ RBV therapy. The purpose of the trial is to study the efficacy of TMC435 in combination with PegINFα-2a and RBV for 48 weeks of treatment compared to the approved regimen of telaprevir in combination with PegINFα-2a and RBV for 48 weeks of treatment. The study will consist of a screening period (maximum 6 weeks), treatment period (48 weeks) and post-treatment period (until 72 weeks after the start of treatment). For the first 12 weeks one group of patients will take TMC435 and TVR placebo, plus PegINFα-2a and RBV. The other group will take TMC435 placebo and TVR, plus PegINFα-2a and RBV. After 12 weeks, patients in both arms will only take PegINFα-2a and RBV up to week 48. After patients stop taking study medication, they will continue to go to the doctor's office for study visits until a total of 72 weeks after they start study treatment. Patients will be monitored for safety throughout the study. Study assessments at each study visit may include, but are not limited to: blood and urine collection for testing, electrocardiogram (ECG) assessments (a measurement of the electrical activity of your heart), patient questionnaires, and physical examinations.