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Boehringer Ingelheim Enrolls First Patients in Pivotal Phase 3 Interferon-Free Hepatitis C Trial Program
Date:1/17/2013

d to announce that the first patients are now enrolled in our Phase 3 HCVerso™ program, including at U.S. trial sites," said Peter Piliero , M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Patients infected with HCV may benefit most from an individualized treatment approach since a person's genetics, type of virus, and stage of liver disease vary from patient to patient. Our investigational interferon-free regimen has shown particular promise in treating patients with HCV genotype-1b so we have decided to enroll these patients in our Phase 3 trial program. Our goal is for an interferon-free future and ensuring patients are treated with the most effective treatment for them individually."

Results from the SOUND-C2 study, which were presented in November 2012 at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), found that up to 85 percent of patients infected with HCV GT-1b treated with Boehringer Ingelheim's investigational IFN-free regimen of faldaprevir, BI 207127 and ribavirin achieved viral cure at 12 and 24 weeks following treatment completion (SVR12 and SVR24).

Eliminating injectable interferon from treatment regimens is a critical goal in HCV as it can be difficult for patients to take due to long treatment duration and often severe side-effects. In addition, up to 50 percent of patients may not be eligible for treatment with interferon. Severe side-effects of interferon include heart failure, sepsis, leukopenia, depression and vision loss, resulting in adherence problems and treatment failure for many patients. Since 1999 there has been a significant increase in deaths due to chronic HCV, accounting for 15,000 deaths in the United States in 2007 alone.

"More effective and tolerable alternatives to interferon would help patients with their decision to start and
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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