75% of treatment-naive chronic hepatitis C patients achieve SVR with Vertex' telaprevir in Ph III trial

Massachusetts, USA-based Vertex Pharmaceuticals saw its shares jump 6% to $35.93 late Tuesday, after it reported positive Phase III data for its hepatitis C treatment telaprevir. The group added that it plans to apply for market approval during the second half of the year.

Vertex announced that 75% of people chronically infected with genotype 1 hepatitis C virus (HCV) who had not previously been treated achieved a sustained viral response (SVR or viral cure) after receiving a 12-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone, in the Phase 3 ADVANCE trial. 69% of people achieved SVR after receiving an eight-week telaprevir-based combination regimen, followed by treatment with pegylated-interferon and ribavirin alone. 44% of those in the control arm achieved SVR after 48 weeks of treatment with the currently approved regimen of pegylated-interferon and ribavirin.

The safety and tolerability profile of telaprevir in the ADVANCE trial was consistent with the profile reported in Phase II studies, with an improvement in treatment discontinuation rates due to adverse events. Adverse events leading to discontinuation of all study drugs occurred in 6.9%, 7.7% and 3.6% of patients in the 12-week telaprevir-based arm, the eight-week telaprevir-based arm and the control arm, respectively.