Phase 3 trial of telaprevir for the treatment of hepatitis C

Vertex announced results from its Phase 3 trial of telaprevir in treatment-naïve patients chronically infected with genotype 1 hepatitis C virus (HCV).  This randomized, double-blind, placebo-controlled trial, known as the ADVANCE trial, enrolled approximately 1095 patients at 114 clinical sites worldwide. The primary endpoint of the trial was sustained viral response (SVR) defined as the proportion of patients who had undetectable HCV RNA both at the end of treatment and 24 weeks after the end of treatment. The secondary endpoint was to evaluate the safety of telaprevir when dosed in combination with pegylated-interferon and ribavirin.

Seventy five percent of the patients achieved a SVR or viral cure after receiving a 12-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone. Sixty nine percent of patients achieved SVR after receiving an 8-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone. Forty four percent of patients in the control arm achieved SVR after 48 weeks of treatment with the currently approved regimen of pegylated-interferon and ribavirin.

Telaprevir is an investigational, oral inhibitor of HCV protease, an enzyme essential for viral replication.

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