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Sustained Viral Response from Phase 2 Studies of BI 201335, Including Difficult-to-Treat HCV Patient Types
Date:11/8/2011

BI 201335 on the background of 24 weeks of PegIFN/RBV was sufficient to achieve sustained viral response (SVR).  Patients with undetectable viral load prior to week 8 had similar SVR rates, whether they were treated for 12 or 24 weeks with BI 201335 (80 percent and 82 percent, respectively).

The most frequent adverse events (AEs) in SILEN-C3 were mild gastrointestinal disorders, rash, photosensitivity and jaundice due to isolated unconjugated hyperbilirubinemia.

In this open-label Phase 2 trial, 159 treatment-naive GT1 HCV patients were randomized to receive 120 mg BI 201335 once daily for 12 or 24 weeks, each after three days lead-in (LI) with PegIFN/RBV.  In both groups, PegIFN/RBV was given for 24 weeks.  Patients who did not have an eRVR continued PegIFN/RBV to week 48.  eRVR was defined as viral load less than 25 IU/mL at week 4 and undetectable at weeks 8-18.  In the 12 week treatment group, 72 percent of patients had an eRVR and in the 24 week treatment group, 82 percent of patients had an eRVR.

(Abstract #226) Treatment with the 2nd Generation HCV Protease Inhibitor BI 201335 Results in High and Consistent SVR Rates – Results from SILEN-C1 in Treatment-Naive Patients Across Different Baseline Factors

This analysis of SILEN-C1 evaluated SVR according to various baseline characteristics among patients who received BI 201335 240 mg once daily without LI.

The majority of patients with more difficult-to-treat HCV types – specifically GT1a and IL-28B non-CC allele patients – achieved SVR.  Among patients with GT1a HCV (n=32), a type that traditionally is associated with lower treatment response rates compared to GT1b, 82 percent achieved SVR.  Among GT1b HCV patients (n=38), 84 percent achieved SVR.  In addition, SVR was 71 percent for patients with non-CC alleles of the IL-28B gene (n=29).  Patients with CC alleles (n=11) or for whom IL-28B genotyping wa
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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