Telaprevir: Phase III data

In the double-blind, international Phase III REALIZE trial in 662 patients with HCV genotype 1 infection who failed previous therapy, simultaneous-start and delayed-start telaprevir regimens plus standard of care (SOC; Pegasys peginterferon alfa-2a and Copegus ribavirin) each met the primary endpoint of a significantly greater proportion of patients achieving an SVR 24 weeks after the end of treatment vs. SOC alone (64% and 66%, respectively, vs. 17%; p<0.0001 for each).

SVR rates in prior relapsed patients (n=354) for simultaneous-start and delayed-start telaprevir regimens plus SOC were 83% and 88%, respectively, vs. 24% for SOC alone (p<0.0001 for each). SVR rates in prior partial responders (n=124) for simultaneous-start and delayed-start telaprevir regimens plus SOC were 59% and 54%, respectively, vs. 15% for SOC alone (p<0.0001 for each). SVR rates in prior null responders (n=184) for simultaneous-start and delayed-start telaprevir regimens plus SOC were 29% and 33%, respectively, vs. 5% for SOC alone (p<0.001 for each). ...