AbbVie reports 96% response in Phase III hepatitis C study
US drugmaker AbbVie (NYSE: ABBV)has released Phase III results for the investigational three direct-acting-antiviral (3D) regimen plus ribavirin in patients with chronic, genotype 1 (GT1) hepatitis C virus (HCV) infection.
In the 394-patient SAPPHIRE-II study, 96% of subjects who previously failed pegylated interferon and ribavirin treatment, including around 49% of who were prior null responders, achieved sustained virologic response at 12 weeks with the regimen. The majority of patients were GT1a, considered a difficult-to-treat subtype, and the SVR12 rates of GT1a and GT1b were 96% and 97%, respectively. Virologic relapse or breakthrough was noted in 2% of patients receiving the 3D regimen plus ribavirin. In addition, the discontinuation rate due to adverse events was 1%.
Second of six Phase III trials
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