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

RIDGEFIELD, Conn., Jan. 17, 2013 /PRNewswire/ -- Today, Boehringer Ingelheim Pharmaceuticals, Inc. announced that the first patients have been enrolled in the company's pivotal Phase 3 interferon (IFN)-free hepatitis C (HCV) clinical trial program, HCVerso™. Boehringer Ingelheim's investigational IFN-free regimen combines the compounds faldaprevir (BI 201335), a protease inhibitor administered once-daily, and BI 207127, a non-nucleoside polymerase inhibitor administered twice-daily, plus ribavirin. Phase 3 clinical trial sites are established in more than 25 states in the U.S.

The HCVerso™ clinical trial program includes two pivotal Phase 3 IFN-free studies that will enroll approximately 1,000 treatment-naive HCV genotype-1b (GT-1b) patients, including those who are interferon eligible or ineligible. The decision to enroll GT-1b patients in the Phase 3 trials follows results from the Phase 2b SOUND-C studies, where Boehringer Ingelheim's investigational, IFN-free regimen showed higher viral cure rates* in patients with the 1b HCV genotype, the most prevalent type of HCV globally.

New preliminary results from the SOUND-C3 trial show that 100 percent (n=20) of patients with HCV GT-1b  achieved sustained virologic response four weeks (SVR4) after completing a 16 week course of treatment. Two patients experienced serious adverse events and two patients discontinued treatment early due to adverse events in SOUND-C3. Four patients in this study had compensated liver cirrhosis (damaged or scarred liver tissue). These data further support the trial design for Boehringer Ingelheim's pivotal HCVerso™ study. Full results from SOUND-C3 are expected in 2013.

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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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