ABT-450: Additional Phase IIb data
Additional data from the open-label, international Phase IIb Aviator (Study M11-652) trial in 571 patients with HCV genotype 1 infection showed that 96% of treatment-naïve patients (n=79) and 93% of null responders (n=45) who received ABT-450 plus ritonavir, ABT-267, ABT-333 and ribavirin for 12 weeks achieved an SVR 24 weeks after the end of treatment. Additionally, 88% of treatment-naïve patients who received ABT-450 plus ritonavir, ABT-267, ABT-333 and ribavirin for 8 weeks achieved an SVR24 (n=80). In treatment-naïve patients, SVR24 rates for other 12-week ABT-450 regimens were 83% for ABT-450 plus ritonavir, ABT-333 and ribavirin (n=41); 89% for ABT-450 plus ritonavir, ABT-267 and ribavirin (n=79); and 87% for ABT-450 plus ritonavir, ABT-267 and ABT-333 (n=79). In null responders, ABT-450 plus ritonavir, ABT-267 and ribavirin for 12 weeks led to an SVR24 rate of 89% (n=45). Furthermore, 93% of treatment-naïve patients who received ABT-450 plus ritonavir, ABT-267, ABT-333 and ribavirin for 24 weeks achieved an SVR12 (n=80) and 90% achieved an SVR24. In null responders, ABT-450 plus ritonavir, ABT-267, ABT-333 and ribavirin for 24 weeks led to an SVR12 rate of 98% (n=43) and an SVR24 rate of 95%.
In treatment-naïve patients who received ABT-450 plus ritonavir, ABT-267, ABT-333 and ribavirin, there were 10 cases of viral relapse in the 8-week arm, 1 case in the 12-week arm and 2 cases in the 24-week arm. There were no cases of viral relapse in null responders who received ABT-450 plus ritonavir, ABT-267, ABT-333 and ribavirin for 12 or 24 weeks. Patients received once-daily 100 or 200 mg ABT-450 plus 100 mg ritonavir with 1 or both of once-daily 25 mg ABT-267 and twice-daily 400 mg ABT-333 with ribavirin for 8, 12 or 24 weeks. The trial enrolled non-cirrhotic treatment-naïve patients and prior peginterferon alfa-2a and ribavirin null responders. Data were presented at the European Association for the Study of the Liver meeting in Amsterdam. Detailed SVR12 data were reported last year (see BioCentury, Oct. 22, 2012 & Nov. 19, 2012). ...