Roche initiates landmark HCV drug therapy trial

Swiss drug major Roche has initiated a large multinational observational study, called PROPHESYS, in patients with hepatitis C virus infection. This international cohort trial will evaluate important factors that give HCV patients the best chance of treatment success with its two drugs Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin).

According to the Swiss firm, PROPHESYS is the largest study of its kind and will identify factors that influence a patient's response to treatment. It is well known that those who respond early are more likely to achieve a sustained virological response and have less chance of relapse. Over 5,000 HCV sufferers will be treated within this observational study. Patients will be monitored during treatment and for a further 24 weeks after the end of therapy using Roche's highly sensitive Cobas TaqMan real-time polymerase chain reaction tests to measure the amount of HCV in their blood.

The study will examine whether it is possible to predict if a patient will achieve a cure based on his or her response to treatment at weeks two, four or 12. Factors being evaluated include: age, pretreatment viral load, alanine aminotransferase, liver fibrosis stage, metabolic parameters, race, weight and gender. Five hundred centers in 18 countries will participate in the trial. Enrolment is ongoing and the study is expected to conclude in 2010.