Combination ABT 450/r and ABT 267 filed in Japan for HCV-AbbVie

AbbVie has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for the company's investigational, all-oral, ribavirin (RBV) and interferon (IFN)-free, 12-week, two direct-acting antiviral treatment of ABT 450/r and ABT 267 (ombitasvir/paritaprevir/ritonavir (OBV/PTV/r), dosed once daily. The submission is for the treatment of patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection.

The NDA is supported by the Phase III GIFT-I study, which met its primary endpoint, achieving a 95 percent (n=106/112) sustained virologic response rate at 12 weeks post-treatment (SVR12) in the sub-group of previously untreated, non-cirrhotic, adult genotype 1b (GT1b)-infected Japanese patients who were eligible for therapy with IFN and had a high viral load (? 100,000 IU/mL). Additionally, two patients without cirrhosis (0.9 percent) discontinued treatment due to adverse events. GIFT-I included a placebo-controlled arm and studied patients with and without compensated cirrhosis, who were new to therapy or treatment-experienced (with IFN and with or without RBV).