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Positive Phase 2 Results Reported with Boehringer Ingelheim's Investigational HCV Protease Inhibitor in Both Previously Treated and Untreated Patients
Date:4/1/2011

gated hyperbilirubinemia.  Average alanine aminotransferase (ALT) improved in all BI 201335 groups compared to placebo, and there was no excess anemia reported in the study.  Across BI 201335 treatment groups, 4 to 12 percent of patients discontinued BI 201335 due to AEs.  

(Oral abstract #66) SILEN-C2: Sustained Virologic Response and Safety of BI 201335 Combined with Peginterferon Alfa-2a and Ribavirin in Chronic HCV Genotype-1 Patients with Non-Response to PegIFN/RBVThe SILEN-C2 study evaluated the virological response and safety of different doses of BI 201335 in treatment-experienced patients who did not respond to at least 12 weeks of prior treatment with PegIFN/RBV. This patient population is particularly difficult to treat, as patients who have not responded to PegIFN/RBV alone have low response rates to additional treatments. The trial did not include patients who relapsed after initial treatment with PegIFN/RBV.

In this double-blind, randomized, placebo-controlled trial, 288 treatment-experienced GT-1 HCV patients were randomized (2:1:1) to receive either:

  • BI 201335 240mg QD with a three-day LI of PegIFN/RBV;
  • BI 201335 240mg QD plus PegIFN/RBV without LI; or
  • BI 201335 240mg twice-daily (BID) with a three-day LI of PegIFN/RBV

  • In each group, patients were given BI 201335 for 24 weeks in combination with PegIFN/RBV, which was given for 24 or 48 weeks.

    Patients in the two BI 201335 QD groups who achieved eRVR were re-randomized to either stop all treatment at Week 24 or continue PegIFN/RBV until Week 48.

    Treatment Outcomes in SILEN-C2 (Treatment-Experienced Patients)240mg
    QD/LI
    (N=142)240mg
    QD
    (N=76)240mg
    BID/LI
    (N=70)eRVR, %

    43

    45

    47Overall SVR, %

    28

    41

    31Breakthrough*, %

    25

    28

    17Relapse**, %

    25

    9

    19*Rebound on treatment with BI 20133
    '/>"/>

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

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