Positive results from Phase III trial of BI 201335 (Boehringer) for Hepatitis C patients

Interim results from HCVerso, a trial of BI-201335 (faldaprevir), from Boehringer, for Hepatitis C (HCV) showed that 80% of HCV/HIV co-infected patients achieved early treatment success (ETS), as defined by the study protocol. 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 pegylated interferon and ribavirin (PegIFN/RBV). Patients who achieved ETS were eligible for randomization to a shortened duration of treatment (24 weeks versus 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.

The most frequent adverse events (AEs) in STARTVerso 4 were nausea (37%), fatigue (33%), diarrhea (27%), headache (23%), and weakness (22%). Serious AEs were reported in 32 patients (10%), including three deaths. Results were presented at the 20th annual Conference on Retroviruses and Opportunistic Infections.