AbbVie released top-line Phase 3 results for its investigational, all-oral, ribavirin (RBV)-free, two direct-acting antiviral treatment with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection in Japan. The primary endpoint of the GIFT-I study was achieved, demonstrating a 95% (n=106/112) sustained virologic response rate at 12 weeks post treatment (SVR12) in the sub-group of previously untreated, non-cirrhotic adult GT1b Japanese patients who were eligible for therapy with interferon (IFN) and had a high viral load. In the GIFT-I study, the primary efficacy population comprised a sub-group of treatment-naive GT1b chronic HCV infected patient population.

This sub-group consisted of treatment-naive patients without cirrhosis who were eligible for therapy with IFN with or without RBV, had a high viral load (> 100,000 IU/mL) and received at least one dose of the double-blind active study drug. The primary endpoint was assessed at 12 weeks post treatment (SVR12).