TMC435: Interim Phase IIb data

Interim 48-week data from the double-blind Phase IIb ASPIRE (C206) trial in 462 treatment-experienced patients with HCV genotype 1 infection showed that once-daily 150 mg TMC435 for 12, 24 or 48 weeks plus standard of care (SOC; Pegasys peginterferon alfa-2a and Copegus ribavirin) produced end of treatment response rates defined as undetectable HCV RNA levels (<25 IU/mL) at week 48 of 92% in patients who relapsed, 83% in partial responders and 71% in null responders vs. 70%, 17% and 25% for patients in each subgroup who received placebo plus SOC. Additionally, 87%, 77% and 57% of patients who relapsed, were partial responders or were null responders, respectively, who received 150 mg TMC435 for 12, 24 or 48 weeks plus SOC achieved an SVR 4 weeks after the end of treatment vs. 50%, 11% and 23% of patients in each subgroup who received placebo plus SOC. P-values were not disclosed. Patients received placebo or once-daily 100 or 150 mg TMC435 for 12, 24 or 48 weeks in combination with SOC. ...