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Sustained Viral Response from Phase 2 Studies of BI 201335, Including Difficult-to-Treat HCV Patient Types
Date:11/8/2011

s missing (n=31) achieved 100 percent and 86 percent SVR, respectively.  IL-28B is a gene that is an important predictor of the likelihood of response to HCV treatment.  Patients with non-CC alleles of IL-28B are less likely to achieve SVR with PegIFN/RBV treatment.  A previously presented analysis of SILEN-C1 showed there was no benefit of PegIFN/RBV LI dosing.

SILEN-C1 is a double-blind, randomized, placebo-controlled trial that randomized 429 treatment-naive GT1 HCV patients (1:1:2:2) to receive either placebo or BI 201335 120 mg with three days LI of PegIFN/RBV, BI 201335 240 mg once daily with three days LI or BI 201335 240 mg once daily without LI.  In each treatment group, BI 201335 was given for 24 weeks together with PegIFN/RBV for 24 or 48 weeks.  SVR results from all SILEN-C1 study groups were previously presented at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) in April 2011.

In SILEN-C1, the most frequent dose-dependent AEs in BI 201335 treatment groups were gastrointestinal disorders, rash, photosensitivity and jaundice resulting from isolated unconjugated hyperbilirubinemia.

About Hepatitis C Virus

HCV is an infectious disease of the liver and is a leading cause of chronic liver disease, transplant and failure that affects as many as 175 million people globally, with three to four million new infections occurring each year.  In the United States, an estimated 4.1 million Americans have been infected with HCV, of whom approximately 3.2 million have chronic HCV infection.  Chronic HCV infection is the cause of an estimated 8,000 to 10,000 deaths annually in the United States.  The majority – about 75 to 85 percent – of HCV cases will develop into chronic infection.  It is estimated 20 percent of patients with chronic HCV will develop cirrhosis within 20 years of infection.  The mortality rate after cirrhosi
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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