In this double-blind, placebo-controlled study, 57 HCV genotype (GT)-1 patients (n = 27 treatment-na茂ve [TN]; n = 30 treatment-experienced [TE]) with compensated liver disease were randomised for 28-day treatment with 400, 600, or 800 mg BI 207127 three times daily (TID) or placebo (only TN) in combination with peginterferon alfa 2a and ribavirin (PegIFN/RBV). Plasma HCV RNA was measured by Roche COBAS TaqMan assay.
HCV RNA decreased in a dose-dependent manner with little difference between 600 mg (TN 5.6 log10, TE 4.2 log10) and 800 mg (TN 5.4 log10, TE 4.5 log10). Rapid virological response (RVR; HCV RNA <15 IU/ml) at day 28 occurred in 11/19 TN and 4/30 TE patients treated with BI 207127. GT-1b patients had stronger reductions in HCV RNA than GT-1a (RVR: TN 64%
BI 207127 in combination with PegIFN/RBV demonstrated strong antiviral activity with a favourable safety and tolerability profile. The best benefit/risk ratio was observed at 600 mg.