TMC435HPC3007 - Phase III Trial of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy

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 relapsed after previous interferon-based therapy. Patients
in this study will also receive two other drugs for their infection called peginterferon
alfa-2a and ribavirin. 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 alfa-2a and ribavirin. For the next 12 weeks, patients will take
peginterferon alfa-2a and ribavirin only. After that, some patients will continue to take
peginterferon alfa-2a and ribavirin for up to 24 additional weeks. Other patients will stop
taking peginterferon alfa-2a 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, 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. Ribavirin (Copegus ®) will be taken as a tablet twice
each day and the dose will depend on your body weight.