A Study of TMC435 in Genotype 1, Hepatitis C-Iinfected Patients (Treatment-Naive or Interferon-Based Treatment Experienced)

• Proportion of patients with sustained virological response (SVR24 and SVR12) [ Time Frame: Follow-up Week 24 for SVR24 and Follow-up Week 12 for SVR12 ] [ Designated as safety issue: No ]
• Number of patients with adverse events [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: Yes ]
• Plasma concentrations of TMC435 [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]

• Proportion of patients with undetectable HCV RNA [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
• Proportion of patients with viral breakthrough [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
• Proportion of patients showing viral relapse [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
• Proportion of patients within the normal limit of alanine aminotransferase levels [ Time Frame: the end of treatment and Follow-up Week up to 72 weeks ] [ Designated as safety issue: No ]
• Proportion of patients with 2 log 10 IU/mL or more decrease in HCV RNA [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]

The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2b and ribavirin in chronic genotype 1 hepatitis C virus (HCV)-infected patients who are treatment-naive or treatment-experienced (prior relapser or non-responder to Interferon-based therapy) in Japan.

This is an open-label study (all people involved know the identity of the intervention) to evaluate the efficacy and safety of TMC435 (also referred to as jnj-38733214-aaa) in combination with the standard of care therapy (SoC: peginterferon [pegIFN] alfa-2b and ribavirin) in adult, genotype 1 hepatitis C virus (HCV)-infected patients who are treatment-naive (who never received treatment for HCV), prior relapsers (who relapsed after previous interferon [IFN]-based therapy), or non-responders (who failed to respond to previous IFN-based therapy) in Japan. The study objective is to evaluate the efficacy, safety, and pharmacokinetics of TMC435. A sufficient number of treatment-naive patients, patients who are prior relapsers to treatment with IFN-based therapy, and patients who are prior non-responders to tretament with IFN-based therapy will be enrolled and assigned to Panel A, Panel B1, and Panel B2, respectively. Patients in Panel A (treatment-naive) and B1 (prior relapsers to IFN-based therapy) will receive 12 weeks of treatment with TMC435 (100 mg) once daily plus SoC followed by 12 or 36 weeks of treatment with SoC. Patients in Panel B2 (non-responders to IFN-based therapy) will receive 12 weeks of treatment with TMC435 (100 mg) once daily plus standard of care (SoC) therapy for HCV infection followed by an additional 36 weeks SoC. TMC435 is a 100-mg capsule and will be taken orally by mouth. The SoC treatment willl consist of Pegylated interferon (PegIFN alpha-2b) (1.5 mcg/kg) injected with a syringe subcutaneously (under the skin) once weekly and ribavirin 200-mg capsules (daily dose: 600-1000 mg based on body weight) taken orally by mouth 2 times a day after meals given for 24 or 48 weeks.

• Drug: TMC435
  100 mg capsule once daily for 12 weeks
• Drug: Peginterferon alfa-2a (pegIFN alfa-2a)
  PegIFN alfa-2a (PEGINTRON) will be supplied as a vial containing dried and frozen powder with 74,148 or 222 mcg pegIFN alpha-2b attached to 0.7 ml injection water (50, 100 or 150 mcg/0.5mL pegIFN alpha-2b) and will be administered according to the manufacturer's prescribing information as 1.5 mcg/kg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks.
  Other Name: PEGINTRON
• Drug: Ribavirin (RBV)
  The dose of RBV given will be based on the patient's body weight. If body weight is > 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 capsules of 200 mg) after breakfast and 600 mg (3 capsules of 200 mg) after supper. If body weight is > 60 kg to <=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 capsules of 200 mg per intake) after breakfast and supper. If body weight is <=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 capsule of 200 mg) after breakfast and 400 mg (2 capsules of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.
  Other Name: REBETOL

Inclusion Criteria:

• Patient must have chronic genotype 1 HCV infection with HCV RNA level >= 5.0 log10 IU/mL
• Patient has never received treatment for HCV (treatment-naive), relapsed after previous IFN-based therapy (prior relapser) or failed to respond to previous IFN-based therapy (non-responder)
• Patient must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication.

Exclusion Criteria:

• Co-infection with any other HCV genotype or co-infection with the human immunodeficiency virus (HIV)
• Diagnosed with hepatic cirrhosis or hepatic failure
• A medical condition which is a contraindication to peg-IFN or ribavirin therapy
• History of, or any current medical condition, which could impact the safety of the patient in the study