Boehringer Ingelheim presents new data for HCV/HIV candidate faldaprevir

German family-owned pharma major Boehringer Ingelheim announced positive results from STARTVerso 4 in patients with HCV/HIV co-infection with its investigational drug faldaprevir.

Hepatitis C viral cure 12 weeks after the conclusion of treatment (SVR12) was achieved by 72% of all patients in the trial. Patients were enrolled in either 120mg or 240mg faldaprevir dose groups. Further, 80% of all patients were eligible for randomization to a shortened duration of treatment (24 versus 48 weeks) because they achieved protocol-defined early treatment success (ETS) and 86% of these patients achieved SVR12. STARTVerso 4 is a Phase III trial that enrolled 308 hepatitis C (HCV) treatment-naive or experienced patients with HCV/HIV co-infectionand evaluated the efficacy and safety of the investigational compound faldaprevir in combination with pegylated interferon and ribavirin (PegIFN/RBV).

"The SVR12 data from STARTVerso4 are encouraging, especially given the inclusion of patients with cirrhosis," said Peter Piliero, vice president, clinical development and medical affairs, US subsidiary Boehringer Ingelheim Pharmaceuticals, adding: "Comprehensive data from our STARTVerso clinical trial program, including data from patients with HCV/HIV co-infection, have been filed with the FDA as part of our New Drug Application for faldaprevir."