ABT-450: Additional Phase II data
Additional data from the open-label, U.S. Phase II CO-PILOT (Study M12-746) trial in 50 patients with HCV genotype 1 infection showed that 93% (n=14) and 95% (n=19) of treatment-naïve patients receiving once-daily 150 or 250 mg ABT-450, respectively, plus ritonavir, ribavirin and ABT-333 for 12 weeks without interferon achieved an SVR 12 weeks after the end of treatment. In 17 non-responders receiving low-dose ABT-450 plus ritonavir, ribavirin and ABT-333 for 12 weeks without interferon, 47% achieved an SVR 12 weeks after the end of treatment. However, 6 non-responders experienced viral breakthrough while on treatment and 3 non-responders relapsed after treatment ended. The most common adverse events were fatigue, nausea and headache. Additionally, 1 patient discontinued treatment due to asymptomatic elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels at week 2. Data will be presented at the European Association for the Study of the Liver meeting in Barcelona this month. ...