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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

RIDGEFIELD, Conn., Nov. 2, 2013 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. today announced new data from its Phase 3 clinical trial program, STARTVerso™, which evaluates the investigational protease inhibitor, faldaprevir, in combination with pegylated interferon and ribavirin (PegIFN/RBV). The Phase 3 clinical program includes trials in treatment-naive (STARTVerso™1&2 - NCT01343888, NCT01297270), treatment-experienced (STARTVerso™3 - NCT01358864), and HIV/HCV coinfected (STARTVerso™4 - NCT01399619) patients with genotype-1 (GT1) hepatitis C (HCV). The primary efficacy endpoint of all trials is viral cure 12 weeks after the conclusion of treatment (SVR12).

In a pooled analysis of treatment-naive, genotype 1 patients (STARTVerso™1&2), 73% (382/521) and 72% (378/524) of all patients treated with 120mg or 240mg of faldaprevir once-daily, both in combination with PegIFN/RBV, respectively, achieved SVR12. In comparison, 50% (131/264) of patients treated with PegIFN/RBV alone achieved SVR12. Also in the pooled analysis, 84% (436/521) of patients who received a regimen including 120mg of faldaprevir once-daily were eligible for an overall shortened time on treatment of 12 weeks on faldaprevir and 24 weeks on PegIFN/RBV. Of these patients, 83% (362/436) achieved SVR12.

In treatment-experienced patients (STARTVerso™3), 12 weeks of faldaprevir-based treatment (240mg once-daily), in combination with PegIFN/RBV, demonstrated SVR12 of 70% (69/99) in patients who relapsed on previous HCV treatment, compared to
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.
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