Phase 3 Results Announced for Faldaprevir for HCV/HIV Co-infection
Boehringer Ingelheim announced the first interim results in HCV/HIV co-infected patients from its ongoing Phase 3 hepatitis C (HCV) clinical trial program (HCVerso). Faldaprevir (BI 201335) is an investigational, oral protease inhibitor that is specifically designed to target viral replication in the liver.
The interim results showed that 80% of HCV/HIV co-infected patients achieved early treatment success (ETS), as defined by the study protocol, when given an investigational HCV regimen that included faldaprevir. Results were consistent across patients regardless of HIV therapy or prior HCV treatment status, including patients who were HCV treatment-naive or had previously relapsed during HCV treatment with PegIFN/RBV. Patients who achieved ETS were eligible for randomization to a shortened duration of treatment (24 weeks vs. 48 weeks). Investigators also reported on-treatment virologic response at week 12, which showed that 84% of all study patients had undetectable levels of hepatitis C virus.
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