A Study of TMC435 in Combination With Peginterferon Alfa-2A and Ribavirin for Hepatitis C Virus Genotype-1 Infected Patients Who Participated in a Control Group of a TMC435 Study

This is a roll over trial of TMC435 for patients with genotype-1 HCV infection who
participated in the control (placebo; substance containing no active medication) group of a
TMC435 trial or who received a treatment for up to 14 days with antivirals directed against
HCV in a previous Tibotec trial. Patients in this study will receive TMC435 in combination
with peginterferon alfa-2a (Pegasys) and ribavirin (Copegus) followed by peginterferon
alfa-2a and ribavirin alone. The total treatment duration will be 24 or 48 weeks, depending
on how the patients respond to treatment and which was their previous response to
peginterferon alfa-2a and ribavirin alone. The study doctor will inform each patient about
how to take their study medication and when they should stop taking it. After a patient
stops taking study medication, they will contiue to come to the doctor's office for study
visits until 24 weeks (in some cases up to 48 weeks) after end of treatment. The total
duration of the study is 78 weeks (including screening). Patients will be monitored for
safety throughout the study. Study assessments at each visit may include but are not limited
to: blood and urine collection for testing, electrocardiogram (ECG) assessments (a
measurement of the electrical activity of the heart) and physical examinations. TMC435 will
be taken as an oral capsule of 150 mg once per day. Peginterferon (Pegasys) will be given as
an injection of 180 µg once each week. Ribavirin will be taken as tablets (Copegus) twice
each day and the dose will depend on patient's body weight.

Inclusion Criteria:

- Patients who participated in the placebo arm of a TMC435 study who did not achieve
undetectable HCV RNA levels at end of treatment or who relapsed within 1 year after
end of treatment OR Patients who received short-term direct-acting antiviral therapy
in a Tibotec-sponsored study.

- Liver disease stage documented by liver biopsy is required within 3 years prior to
screening unless contraindicated.

Exclusion Criteria:

- Infection with human immunodeficiency virus.

- Liver disease not related to hepatitic C infection.

- Significant laboratory abnormalities or other active diseases.

- Pregnant or planning to become pregnant.

- Prematurely stopped medication in previous TMC435 study for non-compliance or for
safety reasons.