Nov 2 2009
More than 80 percent of hepatitis C patients in each arm of the Phase 2 Study C208 achieved a sustained viral response (SVR) with a telaprevir-based regimen according to results of an intent-to-treat (ITT) analysis announced today by Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX). The data from Study C208 will be presented in an oral presidential plenary session at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which began yesterday in Boston. Telaprevir is a hepatitis C virus (HCV) protease inhibitor being developed by Vertex Pharmaceuticals Incorporated in collaboration with Tibotec and Mitsubishi Tanabe Pharma.
Study C208 explored telaprevir-based regimens dosed either every 12 hours (q12h; twice daily) or every eight hours (q8h; three times daily) combined with either peg-IFN-alfa-2a (PEGASYS®) or peg-IFN-alfa-2b (PEGINTRON®) and ribavirin (RBV), for 12 weeks followed by an additional 12 weeks of peg-IFN and RBV in a response-guided trial design that included 161 treatment-naïve patients (intent-to-treat analysis) with genotype 1 hepatitis C virus (HCV) infection. Across the four arms, SVR rates were 82 and 83 percent in patients treated with the every 12 hour telaprevir-based regimen (PEGINTRON and PEGASYS, respectively) and 81 and 85 percent in patients treated with the every 8 hour regimen (PEGINTRON and PEGASYS, respectively). For the majority of patients, these SVR rates were obtained with a 24-week telaprevir-based regimen.
“With high SVR rates and similar safety outcomes between the twice-daily and three-times-daily treatment groups, the results from this exploratory study support the future evaluation of telaprevir-based regimens dosed twice daily,” said Professor Patrick Marcellin, M.D., from Beaujon Hospital in Clichy, France. “These results also highlight the potential future role for response-guided therapy with the goal of improving treatment outcomes and potentially shortening the duration of therapy for the majority of patients.”
Source: Vertex Pharmaceuticals