AbbVie has completed its Phase III clinical trial program and released results of four additional studies designed to assess its investigational all-oral, interferon-free therapy with and without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.
Results are of the PEARL-II, PEARL-III, PEARL-IV and TURQUOISE-II studies, which are part of the six Phase III registrational studies being conducted by AbbVie to treat genotype 1 (GT1) hepatitis C virus (HCV) infection using a regimen containing Enanta Pharmaceuticals’ lead protease inhibitor ABT-450.
ABT-450 is part of AbbVie’s investigational three direct-acting antiviral regimen that consists of the fixed-dose combination of ABT-450/ritonavir (150/100mg) co-formulated with ABT-267 (25mg), dosed once daily, and ABT-333 (250mg) with or without ribavirin (weight-based), dosed twice daily.
A total of 2,308 patients from over 25 countries around the world have participated in the six Phase III trials.
The company said that the results of these studies demonstrate high sustained virologic response rates 12 weeks post treatment (SVR12) and tolerability in the GT1 patients.
PEARL-II study is designed to evaluate the efficacy and safety of 12 weeks of treatment with the three direct-acting antiviral regimen with and without ribavirin in non-cirrhotic, GT1b HCV-infected, treatment-experienced adult patients.
About 179 GT1b treatment-experienced patients with no evidence of liver cirrhosis have participated in the trial, of which 91 were randomized to the regimen without ribavirin for 12 weeks, and 88 were randomized to the regimen plus ribavirin for 12 weeks.
In the ribavirin-free arm, 100% (n=91/91) of patients achieved SVR12, while 97% (n=85/88) achieved SVR12 in the ribavirin-containing arm.