TMC435-TiDP16-C216 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

This is a randomized, double-blind (neither physician or patients knows the name of the
assigned drug), placebo-controlled study of TMC435 in patients who are infected with
genotype 1 hepatitis C virus who have never received treatment for this before. Patients in
this study will also receive two other drugs for their infection (either peginterferon
alfa-2a (Pegasys®) and ribavirin (Copegus®) or peginterferon alfa-2b (PegIntron®) and
ribavirin (Rebetol®). The purpose of the study is to investigate if TMC435 is superior to
placebo in reducing hepatitis C virus to an undetectable level 24 weeks after the end of
treatment. For the first 12 weeks, patients will take either TMC435 or placebo, plus
peginterferon and ribavirin. For the next 12 weeks, patients will take peginterferon and
ribavirin only. After that, some patients will continue to take peginterferon and ribavirin
for up to 24 additional weeks. Other patients will stop taking peginterferon and ribavirin.
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
continue to come to the doctor's office for study visits until a total of 72 weeks after
they enroll in the study. The total duration of the study is 78 weeks (including screening).
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. 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. Peginterferon (PegIntron®) will be given as an injection once each
week and the dose will depend on your body weight. Ribavirin will be taken as a tablet
(Copegus ®) or a capsule (Rebetol ®) twice each day and the dose will depend on your body
weight.