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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

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**Rebound after the end of all assigned treatmentBI 201335 once-daily at 240mg plus SOC provided positive Phase 2 results in this very difficult-to-treat patient population. As is seen in SILEN-C1, a three-day LI with SOC was associated with decreased viral response. Phase 3 trials of BI 201335 are in preparation.

The most frequent dose-dependent AEs in BI 201335 treatment groups were gastrointestinal disorders, jaundice resulting from unconjugated hyperbilirubinemia, and mild to moderate rash or photosensitivity. Serious or severe AEs were reported more frequently in the BI 201335 240mg BID with LI group. Discontinuations due to adverse events ranged from 4 percent in the BI 201335 240mg QD without LI group to 23 percent in the BI 201335 240mg BID with LI group.

Additional HCV Studies to be Presented at EASL

  • SVR and pharmacokinetics of the HCV protease inhibitor BI 201335 with PegIFN/RBV in HCV genotype-1 patients with compensated liver cirrhosis and non-response to previous PegIFN/RBV
    (Poster #1231. S. Pol, et al., April 2, 9:00 a.m.-6:00 p.m. CET)
  • Mechanisms of isolated unconjugated hyperbilirubinemia induced by the HCV NS3/4A protease inhibitor BI 201335
    (Poster #1236. R. Sane, et al., April 2, 9:00 a.m.-6:00 p.m. CET)
  • BI 201335 pharmacokinetics and early effect on viral load in HCV genotype-1 patients
    (Poster #1249. C. Yong, et al., April 2, 9:00 a.m.-6:00 p.m. CET)
  • Preclinical characterization of the hepatitis C virus NS5B polymerase non-nucleoside inhibitor BILB 1941
    (Poster #1215. G. Kukolj, et al., April 2, 9:00 a.m.-6:00 p.m. CET)

  • About Hepatitis C Virus (HCV)HCV is an infectious disease of the liver and is a leading cause of chronic liver disease and liver transplant. The number of individuals chronically infected with HCV globally has been estimated at 170 million, with three to four million new infections occurring each year. Only about 20-45 percent of patient
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    SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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