ABT-450 plus ritonavir/ombitasvir: Additional Phase III data

Additional data from the open-label, international Phase III TURQUOISE-II (Study M13-099) trial in 380 patients with chronic HCV genotype 1 infection with compensated liver cirrhosis showed that AbbVie's all-oral 3D regimen - comprising co-administration with once-daily 150 mg ABT-450 plus 100 mg ritonavir, once-daily 25 mg ABT-267 and twice-daily 250 mg ABT-333 - with ribavirin for 12 weeks led to an SVR 12 weeks after end of treatment in 88.6% of genotype 1a patients (n=140) and 98.5% of genotype 1b patients (n=68). SVR12 rates were 92.2% for treatment-naive genotype 1a patients (n=64) and 100% for treatment-naive genotype 1b patients (n=22). In treatment-experienced genotype 1a patients, SVR12 rates were 80% for prior null responders (n=50), 93.3% for prior relapsers (n=15) and 100% for prior partial responders (n=11). In treatment-experienced genotype 1b patients, SVR12 rates were 100% for prior null responders (n=14), 100% for prior relapsers (n=25) and 85.7% for prior partial responders (n=7).

The 3D regimen with ribavirin for 24 weeks led to an SVR12 in 94.2% of genotype 1a patients (n=121) and 100% of genotype 1b patients (n=51). SVR12 rates were 92.9% for treatment-naive genotype 1a patients (n=56) and 100% for treatment-naive genotype 1b patients (n=18). In treatment-experienced genotype 1a patients, SVR12 rates were 92.9% for prior null responders (n=42), 100% for prior relapsers (n=13) and 100% for prior partial responders (n=10). In treatment-experienced genotype 1b patients, SVR12 rates were 100% for prior null responders (n=10), 100% for prior relapsers (n=20) and 100% for prior partial responders (n=3). On-treatment virologic failure occurred in 1 patient in the 12-week arm and 3 patients in the 24-week arm. Data were presented at the European Association for the Study of the Liver meeting in London and published in the New England Journal of Medicine. ...