Vertex Starts Global Phase 3b Study to Evaluate the Potential for People with Hepatitis C to Achieve a Viral Cure with a Total Treatment Duration of 12 Weeks of INCIVEK Combination Therapy

Vertex Pharmaceuticals Incorporated VRTX today announced the initiation of a Phase 3b study called CONCISE that will evaluate the potential for treatment with INCIVEK™ (telaprevir) combination therapy to be shortened to 12 weeks in people with genotype 1 chronic hepatitis C who have the ‘CC' variation near the IL28B gene. INCIVEK is administered in combination with pegylated-interferon and ribavirin. Approximately one-third of people with hepatitis C have the ‘CC' genotype, which has been associated with higher sustained viral response rates and faster response to interferon-based treatment. In this study, INCIVEK will be taken twice a day. The study is expected to enroll 350 people in the United States and Europe who are new to treatment or who have relapsed after at least one prior course of treatment with pegylated-interferon and ribavirin alone. The primary endpoint of the study is the proportion of patients who achieve a sustained viral response 12 weeks after the last planned dose of study drug.