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Phase 3 data show viral cure rates achieved in a broad range of patients with genotype-1 hepatitis C taking investigational compound faldaprevir plus PegIFN/RBV
Date:11/2/2013

s in the STARTVerso™ program (STARTVerso™3) are treatment-experienced, meaning they had attempted previous HCV treatment but did not achieve viral cure
  • 40% of patients in STARTVerso™3 (treatment-experienced patients) have advanced liver disease (>/=F3 fibrosis)
  • 59% of patients in STARTVerso™1&2 (treatment-naive patients) have a non-CC IL28B genotype; in previous studies, these patients have been less likely to achieve viral cure
  • "These pivotal data from STARTVerso™ are important for Boehringer Ingelheim's HCV portfolio as they support the filing of a New Drug Application for faldaprevir with the Food and Drug Administration," said Peter Piliero, M.D., vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "These results take us a step closer towards our goal of making faldaprevir available for patients who urgently need HCV treatment."

    In the STARTVerso™ clinical trial program, adverse events (AEs) most commonly included nausea, fatigue, diarrhea, headache, anemia, weakness, rash and jaundice due to transient bilirubin elevation (unconjugated hyperbilirubinemia). In STARTVerso™1&2, anemia occurred in 14%, 13%, and 14% of patients taking 120mg and 240mg faldaprevir regimens or PegIFN/RBV alone, respectively. Hyperbilirubinemia occurred in 12% (120mg), 46% (240mg) and less than 1% (PegIFN/RBV) of patients, and was transient. ALT elevations in the faldaprevir arms were similar to placebo, and occurred in 2% (120mg), 2% (240mg) and 3% (PegIFN/RBV) of patients. Gastrointestinal side effects occurred in 11% (120mg), 18% (240mg) and 7% (PegIFN/RBV) of patients. Rash occurred in 7% (120mg), 10% (240mg) and 4% (PegIFN/RBV) of patients. There was no occurrence of photosensitivity in the faldaprevir 120mg arm, and a 1% occurrence in the 240mg arm. Bilirubin associated AEs occurred in 3% (120mg), 9% (240mg) and
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    SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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