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Positive Phase 2 Results Reported with Boehringer Ingelheim's Investigational HCV Protease Inhibitor in Both Previously Treated and Untreated Patients

Fri, 04/01/2011 - 6:37am
Bio-Medicine.Org

BERLIN and RIDGEFIELD, Conn., April 1, 2011 /PRNewswire/ -- New data presented today at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) demonstrate the antiviral activity of Boehringer Ingelheim's once-daily oral protease inhibitor, BI 201335, in both treatment-naive and -experienced patients with chronic genotype-1 (GT1) hepatitis C virus (HCV), the most challenging genotype of HCV to treat.  Results from SILEN-C1 show a sustained viral response (SVR) in 71 to 83 percent of treatment-naive patients who received BI 201335 once-daily plus the current standard-of-care (SOC) [pegylated interferon (PegIFN) and ribavirin (RBV)].

Results from SILEN-C2 show an SVR in 28 to 41 percent of treatment-experienced patients who received BI 201335 once-daily plus PegIFN and RBV.

"SILEN-C1 and 2 have shown positive Phase 2 results in a broad range of HCV patients," said Peter Piliero, M.D., executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The current standard-of-care in HCV is not effective for enough patients. Protease inhibitors such as BI 201335 represent potential new options to improve outcomes and the possibility to shorten the duration of treatment for HCV disease."

"Boehringer Ingelheim is continuing its long heritage in virology and commitment to develop new medicines for HCV," continued Piliero. "BI 201335 is part of BI's growing HCV portfolio, which is being investigated with the goal of improving treatment and cure rates for HCV patients.  We are excited that we will commence our Phase 3 trial program with BI 201335 in the near future, based on the results of these Phase 2 studies."

(Oral abstract #60) SILEN-C1: Sustained Virologic Response (SVR) and Safety of BI 201335 Combined with Peginterferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Genotype-1 HCV InfectionIn this double-blind, randomized, placebo-controlled trial, 429 treatment-na

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