TMC435: Interim Phase IIb data

Interim data from the double-blind, Phase IIb ASPIRE (C206) trial in 462 treatment-experienced patients with HCV genotype 1 infection showed that once-daily TMC435 plus standard of care (SOC; Pegasys peginterferon alfa-2a and Copegus ribavirin) led to undetectable HCV RNA levels (<25 IU/mL) at week 4 in 81% of patients who relapsed (n=158), 62% of partial responders (n=138) and 38% of null responders (n=100) vs. 4% (n=27), 0% (n=23) and 0% (n=16) of patients in each subgroup who received placebo. At week 12, 92%, 84% and 64% of patients in each respective subgroup achieved undetectable HCV RNA levels vs. 31%, 10% and 21%, respectively, for placebo. Furthermore, 94%, 86% and 78% of patients in each respective subgroup achieved undetectable HCV RNA levels at week 24 vs. 83%, 19% and 44%, respectively, for placebo. TMC435 was well tolerated with fatigue and headache reported as the most common adverse events. Patients received placebo or once-daily 100 or 150 mg TMC435 for 12, 24 or 48 weeks in combination with SOC. ...