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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

SAN FRANCISCO and RIDGEFIELD, Conn., Nov. 8, 2011 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced results from two Phase 2 studies evaluating the combination of the company's protease inhibitor, BI 201335, with pegylated interferon (PegIFN) and ribavirin (RBV) in treatment-naive genotype-1 (GT1) hepatitis C virus (HCV) patients.  The results from the SILEN-C3 and SILEN-C1 studies show that BI 201335 may have the potential to shorten the duration of treatment compared to PegIFN/RBV for a large portion of patients, as well as improve the likelihood of viral cure for patients with characteristics that make their HCV more difficult to treat.  These data were presented in oral sessions at the American Association for the Study of Liver Diseases (AASLD) 2011 Liver Meeting in San Francisco, CA.  Phase 3 studies evaluating BI 201335 in various regimens and patient types are ongoing.

"Shortening the length of treatment is among the goals we have at Boehringer Ingelheim as we seek to innovate a new treatment option for HCV patients.  We are encouraged to see that the SILEN-C3 study results suggest that treatment with BI 201335 beyond 12 weeks may not be needed for treatment-naive patients who had an extended rapid viral response," said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.  "The SILEN-C1 subgroup results from the more difficult-to-treat patient types also are promising.  We look forward to results from our ongoing Phase 3 program with BI 201335."

(Abstract #36) SILEN-C3:  Treatment for 12 or 24 Weeks with BI 201335 Combined with Peginterferon Alfa-2a and Ribavirin (P/R) in Treatment-Naive Patients with Chronic Genotype-1 HCV Infection

The results from SILEN-C3 indicate that among patients who had an extended rapid viral response (eRVR), 12 weeks of treatment with
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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