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Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients
Date:5/21/2013

ORLANDO, Fla., May 21, 2013 /PRNewswire/ -- Janssen R&D Ireland (Janssen) today announced primary efficacy and safety results from the global Phase 3 PROMISE study demonstrating that use of the investigational protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 79 percent of treatment-experienced 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 the study, 37 percent of patients receiving placebo plus pegylated interferon and ribavirin achieved SVR12. In the simeprevir arm, on-treatment failure rates were 3 percent and relapse rates were 19 percent, compared to 27 percent and 48 percent in the placebo arm. All patients had previously relapsed following pegylated interferon-based therapy. The data were presented today as a late breaker oral presentation at Digestive Disease Week 2013 in Orlando, Florida based on abstract number 869b, "Simeprevir (TMC435) With Peginterferon/Ribavirin for Treatment of Chronic HCV Genotype 1 Infection in Patients Who Relapsed After Previous Interferon-Based Therapy: Results From PROMISE, a Phase III Trial."

"Hepatitis C is a complex disease and physicians need multiple treatment options to provide their patients the best possible chance at successful therapy," said Eric Lawitz , M.D., professor of medicine at University of Texas Health Science Center, Vice President, scientific and research development, The Texas Liver Institute and principal investigator of the PROMISE trial. "I'm pleased that the primary efficacy and safety results from the PROMISE study of simeprevir show sustained virologic response in patients who had relapsed following previous treatment with interferon-based regimens."

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SOURCE Janssen R&D Ireland
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