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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