AbbVie submits NDA in Japan for DAA regimen for HCV

AbbVie has submitted a new drug application to the Japanese Ministry of Health, Labour and Welfare to approve its two direct-acting antiviral regimen of paritaprevir/ritonavir with ombitasvir to treat hepatitis C virus infection genotype 1, according to a press release from the manufacturer.

The investigational two direct-acting antiviral treatment, which is ribavirin- and interferon-free, consists of a fixed-dose combination of 150 mg of paritaprevir and 100 mg of ritonavir with 25 mg of ombitasvir (AbbVie), dosed once daily, according to the release.

“We are pleased to announce the regulatory submission of our two direct-acting hepatitis C antiviral treatment in Japan, which follows on quickly from recent approvals of our three direct-acting antiviral treatment in the US, Canada and the European Union,” Scott Brun, MD, vice president of pharmaceutical development for AbbVie, said in the release. “This submission is based on a large phase 3 study in multiple patient types and brings us closer to offering the possibility of cure for patients with chronic genotype 1b hepatitis C infection, the most common form of the disease in the country.”

In the phase 3 GIFT-I study, 95% of treatment-naive, adult Japanese patients with HCV genotype 1b but without cirrhosis (106/112), achieved a sustained virologic response at 12 weeks post-treatment, according to the release. Additionally, only two patients without cirrhosis discontinued treatment due to adverse events.

HCV genotype 1 is the most common HCV genotype in Japan with 60 to 70% of patients infected, according to the release.