TMC435-TiDP16-C208 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

This is a randomized, double-blind (neither physician nor patients know 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 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.