Telaprevir meets HCV endpoint

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said both eight- and 12-week regimens of telaprevir plus Pegasys peginterferon alfa-2a and Copegus ribavirin met the primary endpoint in the Phase III ADVANCE trial to treat HCV genotype 1 infection in treatment-naive patients. The two regimens produced a significantly greater proportion of patients achieving a sustained virologic response (SVR) vs. Pegasys and Copegus alone (69% and 75%, respectively, vs. 44%, p<0.0001 for both). Additionally, the eight- and 12-week telaprevir regimens produced rapid virologic response (RVR) rates of 66% and 68%, respectively, vs. 9% for Pegasys and Copegus alone.

Rates of viral relapse, defined as the proportion of patients who achieved undetectable HCV RNA levels at the completion of all treatment but relapsed during post-treatment follow-up, were 9.5% and 8.6% for the eight- and 12-week telaprevir regimens vs. 28% for Pegasys and Copegus alone. The double-blind, placebo-controlled, international trial enrolled 1,095 patients. Telaprevir is a small molecule HCV NS3/4A protease inhibitor. ADVANCE is the first of three trials as part of a Phase III program for telaprevir in chronic HCV. ...