Vertex presents data of telaprevir Phase 3b CONCISE study in people with genotype 1 chronic HCV

Vertex Pharmaceuticals IncorporatedApr 25 2013

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced new data from an interim analysis of the exploratory global Phase 3b CONCISE study evaluating the potential to shorten total treatment with telaprevir combination therapy to 12 weeks in certain people with genotype 1 chronic hepatitis C virus (HCV) infection who have the IL28B CC genotype. In the CONCISE trial, telaprevir was administered twice daily in combination with pegylated-interferon and ribavirin. Of the 239 people in the study, 159 people completed 12 weeks of telaprevir combination treatment and had undetectable hepatitis C virus at week four of treatment (rapid viral response, or RVR) and were eligible to be randomized. One hundred seven people were randomized to receive no further treatment and 52 people were randomized to receive an additional 12 weeks of treatment with pegylated-interferon and ribavirin alone, for a total of 24 weeks of treatment. In the 12-week total treatment group, of the 85 people with data available at the time of the interim analysis, 87 percent (74/85) had undetectable hepatitis C virus 12 weeks after the end of treatment (SVR12). In the 24-week treatment group, of the 30 people with data available at the time of the interim analysis, 97 percent (29/30) achieved SVR12.

This study includes people with genotype 1 chronic HCV who were new to treatment or who had relapsed after at least one prior course of treatment with pegylated-interferon and ribavirin alone. Approximately one-third of people with hepatitis C have the 'CC' genotype, which has been associated with higher sustained viral response (SVR, or viral cure) rates and faster response to interferon-based treatment. The safety profile of telaprevir combination therapy observed in the CONCISE study through the time of the interim analysis was similar to that seen in previously reported clinical trials. The interim results of this study will be presented at the 48th Annual Meeting of the European Association for the Study of the Liver (EASL) in Amsterdam, Netherlands, April 24 to 28, 2013 (poster #881).

Telaprevir is approved for use in combination with pegylated-interferon and ribavirin by the U.S. Food and Drug Administration (FDA) and Health Canada under the brand name INCIVEK^® (telaprevir) tablets for people with genotype 1 chronic HCV infection with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK's approved dosing schedule is two 375mg tablets three times daily, and it is given for 12 weeks in combination with pegylated-interferon and ribavirin. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks.