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

RIDGEFIELD, Conn., Nov. 2, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced interim data from its Phase 2a hepatitis C (HCV) clinical collaboration (NCT01859962) with Presidio Pharmaceuticals, Inc. that showed all patients (13/13) who reached the 4-week post-treatment follow-up had undetectable levels of hepatitis C virus (SVR4) with an investigational, 12-week, all-oral regimen of faldaprevir and deleobuvir, in combination with Presidio's pan-genotypic NS5A inhibitor, PPI-668, with ribavirin. The primary efficacy endpoint of this ongoing trial is sustained virologic response 12 weeks after completion of treatment (SVR12).

An additional study arm evaluating the regimen without ribavirin, which was added per protocol following initial results in the ribavirin-containing arms, showed that after four weeks on treatment, 12/12 patients had hepatitis C virus levels below an amount that can be quantified (LLOQ).  

These data are being presented during the late-breaking poster session at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), taking place in Washington, D.C.

"We continue to be encouraged by the preliminary results of this investigational triple combination of direct-acting antivirals in patients with genotype-1a HCV, and in particular that, at this stage, the ribavirin-free combination has yielded similar results to the ribavirin-containing arms of the trial," said Jacob Lalezari, M.D., director of Quest Clinical Research in San Francisco, CA.

This ongoing Phase 2a study evaluates 36 treatment-naive genotype-1a HCV patients. Two thirds of patients have the difficult-to-treat CT or TT IL28B genotype. Previous studies have shown that presence of
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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