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Findings from Two Phase 3 Studies of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients
Date:4/23/2013

AMSTERDAM, April 23, 2013 /PRNewswire/ -- Janssen R&D Ireland (Janssen) today announced primary efficacy and safety results from two global Phase 3 studies demonstrating that use of the investigational protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 80 and 81 percent, respectively, of treatment-naive genotype 1 chronic hepatitis C adult patients with compensated liver disease, including all stages of liver fibrosis, when administered once daily with pegylated interferon and ribavirin. In both studies, 50 percent of patients receiving pegylated interferon and ribavirin alone achieved SVR12.

The data will be presented this week at The International Liver Congress 2013 of the European Association for the Study of the Liver (EASL) in Amsterdam, The Netherlands. The QUEST-1 and QUEST-2 data will be discussed in an official EASL press conference on April 24 at 11:00 a.m. CEST.

"More than 390 treatment-naive genotype 1 hepatitis C patients in 39 countries received simeprevir as part of the Phase 3 QUEST trials," said Michael Manns , M.D., professor and chairman, Department of Gastroenterology, Hepatology and Endocrinology, Medical School of Hannover. "I am pleased to be a part of these robust studies and look forward to seeing the results from upcoming trials of simeprevir in treatment-experienced patients later this year."

In QUEST-1 and QUEST-2, patients were randomized to receive simeprevir or placebo for 12 weeks plus pegylated interferon and ribavirin for 24 or 36 weeks. In findings related to a secondary endpoint, 85 percent (QUEST-1) and 91 percent (QUEST-2) of patients receiving simeprevir were able to shorten therapy with pegylated interferon and ribavirin to 24 weeks due to meeting response-guided therapy (RGT) criteria. Of those patients meeting RGT
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SOURCE Janssen R&D Ireland
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