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Boehringer Ingelheim's interferon-free hepatitis C treatment portfolio strengthened by promising interim Phase 2a data
Date:11/2/2013

the CT and TT IL28B genotypes led to a reduced likelihood of achieving viral cure. In addition, more than half the patients in the study (20/36) have pre-existing HCV mutations. These include the Q80K variant in 12 of these patients, all of which had virologic responses to the faldaprevir-based triple direct-acting antiviral (DAA) regimen. Also in this trial, 19% of patients are African American.

"These results add to the growing body of data for HCV regimens containing our investigational compound, faldaprevir," said Peter Piliero, M.D., vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are looking forward to the final results of this trial, as well as our other studies evaluating all-oral regimens, as researchers strive to make an interferon-free future a reality for a broad range of HCV patients."

This study contains three arms:

  • The first arm enrolled 12 patients and is evaluating faldaprevir 120mg once-daily (QD), PPI-668 200mg once-daily (QD) and deleobuvir 600mg twice-daily (BID) with ribavirin
  • The second arm enrolled 12 patients and is evaluating faldaprevir 120mg QD, PPI-668 200mg QD and deleobuvir 400mg BID with ribavirin
  • The third arm enrolled 12 patients and is evaluating faldaprevir 120mg QD, PPI-668 200mg QD and deleobuvir 600mg BID without ribavirin

All patients in the study have received at least 4 weeks of treatment and 97% (35/36) achieved LLOQ. To date, one patient who had pre-existing NS5A and NS5B mutations failed treatment. This patient had a partial response to treatment but developed viral breakthrough and was discontinued.

To date, there has been one treatment discontinuation due to adverse events. The patient self-discontinued at week 9 on treatment due to gastrointestinal side effects. This patient had undetectable levels of HCV RNA by day 10 of trea
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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