NEJM publishes data from Vertex INCIVEK Phase 3 study on genotype 1 chronic hepatitis C

Sep 15 2011

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the New England Journal of Medicine (NEJM) published data from a Phase 3 study of INCIVEK™ (telaprevir) tablets in people with genotype 1 chronic hepatitis C who were new to treatment. In ILLUMINATE, INCIVEK (in-SEE-veck) was given for the first 12 weeks in combination with pegylated-interferon and ribavirin. Nearly two-thirds of patients responded early to INCIVEK combination treatment (measured by having undetectable hepatitis C virus at weeks 4 and 12 of treatment) and were randomly assigned to receive an additional 12 weeks or 36 weeks of treatment with pegylated-interferon and ribavirin alone. Similarly high rates of sustained viral response (SVR, or viral cure) were achieved by people in both treatment groups. Rash and anemia were the most common side effects reported with INCIVEK in this study and each led to treatment discontinuation of all medicines in about 1 percent of people during the INCIVEK treatment phase. Data from ILLUMINATE are published in the September 15, 2011 issue of NEJM.

"These data are important because they showed that patients who respond early to INCIVEK combination treatment have a high likelihood of achieving a viral cure with 24 weeks of therapy," said Kenneth Sherman, M.D., Ph.D., Professor of Medicine at the University of Cincinnati College of Medicine, Director of the Division of Digestive Diseases for UC Health and principal investigator for the study. "With INCIVEK, we know by week four how patients are initially responding and, for people who have not been treated before, we know by week 12 what their chances are of completing all therapy in 24 weeks. I believe these are important motivators for patients to start and stay on treatment."

"Nearly two-thirds of people in this study had an early response to INCIVEK combination treatment and were eligible to stop all therapy at week 24," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "Cutting treatment time in half eliminates 24 weeks of pegylated-interferon and ribavirin and represents a major advance in how hepatitis C is treated."

Source: Vertex Pharmaceuticals Incorporated