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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)

ot available due to treatment duration  

Investigators reported breakthrough broken out by genotype and IL-28B status. In GT1b and GT1a-CC patients, breakthrough occurred in 7 percent of patients in Arm A, 11 percent of patients in Arm B, 19 percent of patients in Arm C, 9 percent of patients in Arm D, and 29 percent of patients in Arm E (no RBV arm). In GT1a non-CC patients, breakthrough occurred in 40 percent of patients in Arm A, 50 percent of patients in Arm B, 25 percent of patients in Arm C, 64 percent of patients in Arm D, and 91 percent of patients in Arm E (no RBV arm).

In this study, the most common adverse events (AEs) were skin (photosensitivity, rash), gastrointestinal (GI) disorders (vomiting, diarrhea), and jaundice due to unconjugated hyperbilirubinemia. Treatment discontinuations due to AEs correlated with increased dosing frequency and treatment duration, with discontinuations ranging from 4.9 percent in Arm A (16 weeks) to 24.7 percent in Arm C (40 weeks). In the arm with BID dosing of BI 207127 (Arm D), discontinuations were 7.7 percent. BID dosing of BI 207127 is planned for Phase 3 investigation.

Other BI data being presented at the EASL Annual Meeting include: Poster PresentationsTitleLead Author Presentation Details SOUND-C2 interim analysis:
The efficacy and safety of the
interferon-free combination of
BI 201335 and BI 207127 in
genotype-1 HCV patients with

V. Soriano

Late Breaker Poster# 1420


Date: Thur, April 19

Time: 12:00 - 1:30 p.m.
CEST/ 6:00 - 7:30 a.m. EDT

 Characterization of HCV NS3
variants that emerged during
virologic breakthrough and
relapse from BI 201335 Phase
2 SILEN-C2 study in
pegylated-interferon plus
ribavirin treatment-
experienced patients

G. Kukolj

Poster# 1185


Date: Sat, April 21

Time: 12:30 – 1:30 p.m.
CEST/ 6:30 &

SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

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