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
BOSTON, Nov. 10, 2012 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. (Janssen) today announced that the use of one once-daily pill of the investigational protease inhibitor simeprevir (TMC435) administered with pegylated interferon and ribavirin led to higher rates of sustained viral response at 24 weeks (SVR24) compared to placebo in patients with Metavir scores of F3 and F4 who were treatment naive and treatment experienced with genotype 1 hepatitis C. Simeprevir was also generally well tolerated and the overall incidence of serious adverse events (AEs) was similar across all treatment arms. The data from the Phase 2b PILLAR and ASPIRE trials were presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
In treatment-naive patients with a Metavir score of F3 (PILLAR), the primary endpoint of SVR24 was achieved in 79 percent of patients in the simeprevir group compared to 72 percent in the control group (pegylated interferon and ribavirin alone). In treatment-experienced patients with a Metavir score of F3 (ASPIRE), SVR24 was achieved in 48 percent of patients in the simeprevir group compared to 8 percent in the control group. In treatment-experienced patients with a Metavir score of F4 (ASPIRE), SVR was achieved in 62 percent of patients in the simeprevir group compared to 0 percent in the control group. In both the PILLAR and ASPIRE trials, serious AEs occurred in 7.6 percent of patients receiving simeprevir plus pegylated interferon and ribavirin compared to 9.8 percent of patients receiving pegylated interferon and ribavirin alone.
"Hepatitis C patients with Metavir scores of F3 and F4 have advanced fibrosis of the liver and are harder to cure than those with limited fibrosis," said Fred Poordad, M.D., chief medical officer of Alamo Medical Research Center and investigator in the ASPIRE and PILLAR studies. "The results presented at AASLD suggest that simeprevir could represent an important new treatment option for people living with advanced hepatitis C if proven in advanced trials."
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