AbbVie's DAA regimen for HCV gets priority review by Japan

The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review for AbbVie’s investigational, direct-acting antiviral regimen of ombitasvir, paritaprevir and ritonavir for the treatment of hepatitis C virus infection, according to a news release from the manufacturer.

The investigational two direct-acting antiviral (DAA) 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.

The MHLW grants priority review to certain medicines on the basis of clinical usefulness and severity of the disease, including HCV, which affects approximately 1.5 to 2 million people in Japan, according to the release.

“AbbVie is pleased that the Japanese MHLW has granted priority review for our interferon and ribavirin-free, 12-week, two direct-acting antiviral treatment regimen,” Scott Brun, MD, vice president of pharmaceutical development of AbbVie, said in the release. “This marks another important advancement in our HCV clinical development program as we aim to provide our HCV treatment to patients across the world. If approved, AbbVie’s HCV treatment holds the potential to be a promising new treatment option for patients living with this chronic infection in Japan.”

AbbVie submitted a new drug application for the DAA regimen in Japan in February. The new drug application and priority review is supported by the phase 3 GIFT-I study in Japanese patients. In the 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. Additionally, only two patients without cirrhosis discontinued treatment due to adverse events. – by Melinda Stevens

Disclosure: Brun is an employee of AbbVie.