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

The open-label, international Phase III PEARL-II (Study M13-389) trial in 179 treatment-experienced patients with chronic HCV genotype 1b infection and no evidence of 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 97% of patients (n=88). The 3D regimen without ribavirin for 12 weeks led to an SVR 12 weeks after the end of treatment in 100% of patients (n=91). The most common reported adverse events were fatigue and headache. No patients in either treatment arm had virologic relapse or breakthrough.

PEARL-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-III, PEARL-IV and TURQUOISE-II (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. ...