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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

ive genotype-1 (GT-1) HCV patients were randomized (1:1:2:2) to receive either:

  • Placebo plus PegIFN/RBV;
  • BI 201335 120mg once-daily (QD) with a three-day LI of PegIFN/RBV;
  • BI 201335 240mg QD with a three-day LI of PegIFN/RBV; or
  • BI 201335 240mg QD plus PegIFN/RBV without LI

  • 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 240mg QD groups who achieved extended rapid virological response (eRVR, defined as plasma viral load less than 25 IU/ml at Week four and undetectable at Weeks 8-20), were re-randomized to discontinue PegIFN/RBV at Week 24 or continue PegIFN/RBV to Week 48.Treatment Outcomes in SILEN-C1 (Treatment-Naive Patients)Placebo
    (N=71)120mg
    QD/LI
    (N=69)240mg
    QD/LI
    (N=142)240mg
    QD
    (N=142)eRVR, %

    16

    80

    78

    87SVR, %

    56

    71

    73

    83Breakthrough*, %

    3

    6

    4

    3Relapse**, %

    14

    7

    11

    8*Rebound on treatment with BI 201335

    **Rebound after the end of all treatment Overall SVR rates reached 83 percent in the 240mg QD group (plus current SOC). A three-day lead in with SOC prior to initiation of BI 201335 was seen to reduce responses by 12 percent and 10 percent in 120mg QD/LI and 240mg QD/LI patient groups.  The LI was also associated with higher rates of viral breakthrough.  Of the patients in the 240mg QD dose group who achieved extended rapid viral response (eRVR, defined as plasma viral load less than 25 IU/ml at Week four and Weeks 8-20) and were re-randomized at Week 24, 93 percent achieved SVR with 24 weeks of SOC (PegIFN/RBV) treatment.  

    The most frequent dose-dependent adverse events (AEs) in BI 201335 treatment groups were gastrointestinal disorders, rash or photosensitivity, and jaundice resulting from isolated unconju
    '/>"/>

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

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