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Phase 2b Study of Boehringer Ingelheim's Interferon-Free Hepatitis C Treatment Shows Undetectable Virus in HCV Genotype-1 Patients 12 Weeks After Treatment Ended (SVR12)
Date:4/19/2012

pean Association of the Study of the Liver (EASL 2012) in Barcelona, Spain (Abstract #101). These results supplement the abstract findings highlighted today during an official EASL press conference.

"We are looking forward to the final results from this study, that we hope will be a significant step towards an interferon-free future for patients with HCV," said Peter Piliero, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are committed to the millions of people around the world who are chronically infected with HCV. Through our clinical trial program HCVerso™, we are working with experts worldwide to ask the difficult questions that remain in HCV to find answers to the challenges that these patients face."

Planning of the interferon-free Phase 3 clinical trial program is underway.

SOUND-C2 Pre-Specified Interim AnalysisIn this open-label Phase 2b study, 362 treatment-naive GT1 HCV patients were randomized into five interferon-free treatment groups, each with 120 mg BI 201335 QD, but with different dosing of BI 207127 and treatment durations. The randomization was stratified by HCV genotype (1a or 1b) and patient IL-28B genotype, with 41 percent of patients being GT1a and 75 percent being IL-28B CT or TT.SOUND-C2 Trial Design and Interim ResultsBI 201335

BI 207127

RBV

Treatment
Duration

SVR12
n (%)A

N=81

120 mg QD

600 mg TID

Y

16 wks

48 (59%)N=80

120 mg QD

600 mg TID

Y

28 wks

49 (61%)C

N=77

120 mg QD

600 mg TID

Y

40 wks

N/A*D

N=78

120 mg QD

600 mg BID

Y

28 wks

53 (68%)E

N=46

120 mg QD

600 mg TID

N

28 wks

18 (39%)* SVR12 data for the 40 week arm of SOUND-C2 is n
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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