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Tibotec releases final results of Phase 3 REALIZE study

Results of the Phase 3 REALIZE study were presented today at the 46th annual meeting of the European Association for the Study of the Liver (EASL) in Berlin.

The final results of the study show:

  • Significantly greater proportion 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.
  • The data also show efficacy in non-responders, divided into prior null- and partial-responders.
  • This is the first time a compound with a new mode of action has shown efficacy in null-responders in a Phase 3 study.
  • Telaprevir also showed efficacy irrespective of a delayed start.

Telaprevir is a potent and selective protease inhibitor (PI) with activity in patients that are new to treatment and who have been previously treated and those who have had little or no response to pegylated-interferon and ribavirin.

Based on findings from the telaprevir Phase 3 program, Janssen has submitted a marketing authorization for telaprevir to the European Medicines Agency and Food and Drug Administration, which is currently under accelerated assessment and priority review respectively.

It is estimated that 170 million people are living with HCV around the world, including more than five million in Europe.