Phase III trial of BI 201335 (Boehringer) succesful for Hepatitis C patients

Results from the pivotal Phase III STARTVerso1 trial of BI 201335 (faldaprevir), from Boehringer, in combination with pegylated interferon and ribavirin (PegIFN/RBV) show that untreated patients with genotype-1 Hepatitis C virus (HCV) who received once-daily faldaprevir plus PegIFN/RBV, 79% and 80% in the 120mg and 240mg arms, respectively, achieved viral cure 12 weeks after treatment was completed (SVR12). This is compared with 52% of patients receiving PegIFN/RBV plus placebo (p<0.0001).>

In addition, early treatment success (ETS) was achieved by 87% and 89% of patients treated with the faldaprevir-based regimen (120mg or 240mg, respectively), meaning they were eligible for an overall shorter treatment duration of 12 weeks faldaprevir/24 weeks PegIFN/RBV. Of those patients who completed treatment early, 86% and 89% (120mg or 240mg, respectively) went on to achieve viral cure (SVR12). The results will be presented at EASL's International Liver Conference.