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news.A majority of patients who have previously failed treatment for chronic genotype 1 hepatitis C virus (HCV) achieved a sustained viral response (SVR) with 12 week telaprevir combination regimens compared with the current standard of care, pegylated-interferon and ribavirin, alone, according to the data from Tibotec Virco-Virology’s REALIZE trial.
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REALIZE is the final of three clinical trials conducted as part of a global Phase 3 registration program for telaprevir in treatment-naïve and treatment-failure patients with chronic HCV infection.
The primary objective of the randomized, double-blind, placebo-controlled Phase 3 trial was to evaluate the superior efficacy of the telaprevir arms for non-responders and relapsers.
The secondary objectives included the evaluation of a delayed start pegylated-interferon and ribavirin arm and efficacy in prior null- and partial-responders separately.
Telaprevir is being developed by Tibotec in collaboration with Vertex Pharmaceuticals and Mitsubishi Tanabe Pharma.
Tibotec has the right to commercialize telaprevir in Europe, Latin America, the Middle East, Africa, India, Australia and New Zealand.
Vertex has the right to commercialize telaprevir in the US, Canada and Mexico.
Mitsubishi Tanabe Pharma has the right to commercialize telaprevir in Japan and certain Far East countries.
Tibotec Virco-Virology, a Janssen Pharmaceutical company, is dedicated to the discovery and development of innovative HIV/AIDS and hepatitis C drugs, and anti-infectives for diseases of high unmet medical need.
Tibotec has submitted a marketing authorization for telaprevir to the European Medicines Agency (EMA), which is currently under accelerated assessment.