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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

criteria to stop treatment at 24 weeks, 91 percent (QUEST-1) and 86 percent (QUEST-2) of patients achieved SVR12.

"Given the long-term health risks associated with hepatitis C, it's important that physicians and patients have multiple options to treat the disease," said Ira Jacobson , M.D., chief of the Division of Gastroenterology and Hepatology, Vincent Astor Distinguished Professor of Medicine, Weill Cornell Medical College, and attending physician, New York-Presbyterian Hospital/Weill Cornell Medical Center. "The results of these Phase 3 trials suggest that simeprevir could represent an important new treatment option for people living with genotype 1 chronic hepatitis C."

Patients enrolled in QUEST-1 and QUEST-2 were stratified by HCV genotype 1 subtype and IL28B genotype. In QUEST-1, SVR12 rates among patients treated with simeprevir with IL28B genotype variations were 94 percent for the CC allele, 76 percent for the CT allele, and 65 percent for the TT allele. In QUEST-2, SVR12 rates among patients treated with simeprevir with IL28B genotype variations were 96 percent for the CC allele, 80 percent for the CT allele, and 58 percent for the TT allele. Among patients with METAVIR scores F3 and F4, 70 percent of patients treated with simeprevir in QUEST-1 and 66 percent of patients treated with simeprevir in QUEST-2 achieved SVR12. Among patients with METAVIR scores F0 to F2, 83 percent of patients treated with simeprevir in QUEST-1 and 85 percent of patients treated with simeprevir in QUEST-2 achieved SVR12. The METAVIR score is used to quantify the degree of inflammation and fibrosis of the liver and patients are scored on a four-point scale. 

"Patient response rates to hepatitis C therapy can be variable, depending on factors such as viral genotype and subtype, and liver fibrosis. Patients with genotype 1a, IL28B genotype TT and METAVIR scores of F3 and F4 can be particularly c
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SOURCE Janssen R&D Ireland
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