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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

14% (7/49) of patients taking PegIFN/RBV alone. In patients who partially responded to previous treatment, 58% (33/57) achieved SVR12, compared to 3% (1/29) of patients taking PegIFN/RBV alone. In patients who showed no response to previous treatment, 33% (48/145) achieved SVR12.

Additionally, early sustained viral response rates in patients coinfected with HIV/HCV (STARTVerso™4) showed that 74% (229/308) of patients treated with a faldaprevir-based regimen (120mg or 240mg once-daily), in combination with PegIFN/RBV, had undetectable HCV at four weeks following treatment completion (SVR4). The study includes patients coinfected with HCV and HIV who were treatment-naive or had relapsed after previous HCV therapy with PegIFN/RBV, and were either HIV treatment-naive or being treated with ART.

The results from these and additional studies will be presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), also known as The Liver Meeting®, taking place November 1-5 in Washington, D.C.

"HCV patients have various treatment needs, and this data studying an interferon-based regimen may be particularly encouraging for those with advanced liver disease, including cirrhosis, who may need treatment urgently," said Douglas Dieterich, M.D., professor of medicine in the Division of Liver Diseases, Mount Sinai School of Medicine.

More than 2,200 patients have been studied in the STARTVerso™ trial program, including a large proportion of patients with difficult-to-cure types of HCV:

  • Over 300 patients in the STARTVerso™ program have HIV/HCV coinfection (STARTVerso™4); these patients are known to have lower response rates to treatment and are therefore considered difficult to cure. In this trial, 14% of patients are African American
  • 677 patient
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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