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ARTICLE | Clinical News

TMC435: Additional Phase IIb data

May 14, 2012 7:00 AM UTC

Additional data from the double-blind Phase IIb ASPIRE (C206) trial in 462 treatment-experienced patients with chronic HCV genotype 1 infection showed that 70%, 66% and 61% of patients receiving once-daily 100 mg TMC435 for 12, 24 or 48 weeks plus standard of care (SOC; peginterferon alfa-2a and ribavirin), respectively, achieved an SVR, defined as undetectable HCV RNA levels (<25 IU/mL), 24 weeks after the end of treatment, the primary endpoint, vs. 23% for placebo plus SOC (p<0.001 for all). Additionally, 67%, 72% and 80% of patients receiving once-daily 150 mg TMC435 for 12, 24 or 48 weeks plus SOC, respectively, achieved an SVR 24 weeks after the end of treatment vs. 23% for placebo plus SOC (p<0.001 for all). Data were presented at the European Association for the Study of the Liver meeting in Barcelona. ...