US drugmaker AbbVie (NYSE: ABBV) has revealed promising new results from its hepatitis C development program at the European Association for the Study of Liver’s (EASL) International Liver Congress 2014 in London.
Data from a pivotal Phase III study TURQUOISE-II, which have also been published on-line in The New England Journal of Medicine (NEJM), demonstrated that high response rates can be achieved in patients with compensated liver cirrhosis after both 12 and 24 weeks. TURQUOISE-II is a global, multicenter, randomized, open-label study evaluating the efficacy and safety of 12 weeks or 24 weeks of treatment with AbbVie's regimen with ribavirin (RBV) in adult patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection with compensated liver cirrhosis. Patients achieved sustained virologic response rates 12 weeks post-treatment (SVR12) of 91.8% and 95.9% in the 12-week and 24-week treatment arms, respectively. Patients in the study were either new to therapy or treatment-experienced (failed previous treatment with pegylated interferon and RBV).
Scott Brun, vice president, pharmaceutical development, AbbVie, said: “We designed our comprehensive HCV clinical trial program to generate important information about treating a range of GT1 patients. These data will help the medical community better understand the use of our regimen for specific patient types they encounter with GT1 infection in actual practice.”
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