BI 201335 (Boehringer) Phase III trials success in Hep C

In a pooled Phase III analysis of treatment-naive, genotype 1 Hepatitis C patients (STARTVerso1&2), 73% and 72% of patients treated with 120mg/240mg of BI 201335 (faldaprevir), from Boehringer, once-daily, both in combination with pegylated interferon and ribavirin (PegIFN/RBV), respectively, achieved SVR12. In comparison, 50% of patients treated with PegIFN/RBV alone achieved SVR12.

In treatment-experienced patients (STARTVerso3), 12 weeks of faldaprevir-based treatment (240mg once-daily), in combination with PegIFN/RBV, demonstrated SVR12 of 70% in patients who relapsed on previous HCV treatment, compared to 14% of patients taking PegIFN/RBV alone. In patients who partially responded to previous treatment, 58% achieved SVR12, compared to 3% of patients taking PegIFN/RBV alone.

Additionally, early sustained viral response rates in patients coinfected with HIV/HCV (STARTVerso4) showed that 74% of patients treated with a faldaprevir-based regimen in combination with PegIFN/RBV, had undetectable HCV at four weeks following treatment completion (SVR4). Data were presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases.