ARTICLE | Clinical News

Interim data for TMC435 in ASPIRE

November 19, 2010 2:00 AM UTC

Medivir AB (SSE:MVIR B) reported interim data from the Phase IIb ASPIRE (C206) trial of TMC435 to treat chronic HCV infection. Once-daily TMC435 plus standard of care (SOC) led to undetectable HCV RNA levels at week 24 of treatment in 94% of patients who relapsed, 86% of partial responders and 78% of null responders vs. 83%, 19% and 44% of patients in each subgroup who received placebo. The primary endpoint is the proportion of patients achieving a sustained virologic response (SVR) defined as undetectable HCV RNA levels 24 weeks after the end of treatment. The double-blind trial enrolled 462 treatment-experienced patients with HCV genotype 1 infection. ...