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Efficacy and Safety Data from Phase 2B Trials of Janssen's Simeprevir in Hepatitis C Patients with Advanced Fibrosis of the Liver Presented at Annual Meeting of the American Association for the Study of Liver Diseases
Date:11/10/2012

tment option for people living with advanced hepatitis C if proven in advanced trials."

Simeprevir, an investigational NS3/4A protease inhibitor jointly developed by Janssen and Medivir, is currently in Phase 3 studies as a once-daily treatment taken in combination with pegylated interferon and ribavirin for the treatment of genotypes 1 and 4 chronic hepatitis C. It is also being studied in separate Phase 2 trials with other direct-acting antiviral agents as part of interferon-free regimens, with and without ribavirin. This includes a recently initiated Phase 2a trial of an interferon-free regimen with simeprevir and TMC647055, Janssen's non-nucleoside polymerase inhibitor (NNI) currently in development for hepatitis C.

"We are encouraged by these data, which show sustained viral response and tolerability in both treatment-naive and more challenging-to-cure patients," said Maria Beumont, M.D., Medical Leader for simeprevir, Janssen Research & Development. "We look forward to further evaluating the utility of simeprevir in combination with other agents for the treatment of hepatitis C."

About the PILLAR & ASPIRE Trials  
In the two international, Phase 2b, randomized, double-blind, placebo-controlled studies, patients were either treatment naive (PILLAR) or treatment experienced (ASPIRE), and received pegylated interferon and ribavirin alone or in combination with once-daily simeprevir. In PILLAR, 309 treatment-naive hepatitis C patients received either 75 or 150 mg of once-daily simeprevir for 12 or 24 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks depending on their response to treatment. In ASPIRE, 396 treatment-experienced patients received either 100 or 150 mg of once-daily simeprevir for 12, 24 or 48 weeks plus pegylated interferon and ribavirin for 48 weeks.

The post hoc analyses of PILLAR and ASPIRE presented at AASLD (abstracts 83 and 769) evaluated only patients receiving 150 m
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SOURCE Janssen Pharmaceuticals, Inc.
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