ARTICLE | Clinical News

ABT-450: Preliminary Phase II data

November 8, 2010 8:00 AM UTC

Preliminary data from the ongoing, double-blind, dose-ranging Phase II M11-602 trial in 30 evaluable treatment-naïve patients with HCV genotype 1 infection showed that once-daily ABT-450 plus Norvir ritonavir significantly reduced mean HCV RNA levels from baseline to day 3, the primary endpoint, vs. placebo. Specifically, 50, 100 and 200 mg ABT-450 plus 100 mg Norvir reduced mean HCV RNA levels by 4.1, 3.84 and 4.2 log10 IU/mL, respectively, from baseline to day 3 vs. 0.31 log10 IU/mL for placebo (p<0.001 for all). Additionally, 21 of 23 (91.3%) evaluable patients receiving ABT-450 plus Norvir and standard of care (SOC; Pegasys peginterferon alfa-2a and Copegus ribavirin) achieved an RVR defined as HCV RNA levels <25 IU/mL at week 4. Data were presented at the American Association for the Study of Liver Diseases meeting in Boston. ...