ABT-450 plus ritonavir/ABT-267/ABT-333: Phase III data

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 the end of treatment in 92% of patients (n=208). The 3D regimen with ribavirin for 24 weeks led to an SVR 12 weeks after the end of treatment in 96% of patients (n=172). The most common reported adverse events were fatigue, headache and nausea. The rates of virologic relapse or breakthrough were 6% in the 12-week arm and 2% in the 24-week arm. The trial enrolled both treatment-naïve patients and treatment-experienced patients.

TURQUOISE-II is 1 of 6 trials in AbbVie's Phase III program evaluating the ABT-450 plus ritonavir, ABT-267 and ABT-333 regimen with and without ribavirin in >2,300 treatment-naïve and treatment-experienced patients with HCV genotype 1 infection. AbbVie has now reported data from all 6 trials in the program - SAPPHIRE-I, SAPPHIRE-II, PEARL-II, PEARL-III and PEARL-IV (see BioCentury, Nov. 25, 2013 & Dec. 16, 2013). AbbVie said it will start to submit major regulatory applications for the 3D regimen early next quarter, with a U.S. launch slated for this year. ...