+ Regulatory
Kacie Whaley | Oct 6, 2017

Maviret gets OK as hepatitis C treatment in Japan

Patients in Japan with hepatitis C virus (HCV) infection have a new eight-week treatment available now that the Japanese Ministry of Health, Labour and Welfare has approved Maviret (glecaprevir/pibrentasvir), AbbVie said in a release.

Approximately 2 million people in Japan have HCV, one of the highest rates of the infection in the world. The majority of those infected in Japan are those with genotype 1 or 2 HCV without cirrhosis who are new users of direct-acting antiviral (DAA) treatment. Maviret is specifically for these types of patients and is the first of its kind available to the country, the release said.

"New pan-genotypic, ribavirin-free treatments like Maviret that have a short treatment duration have the potential to become a first-line HCV treatment option and will also be fundamental to addressing challenges that remain in the care of this serious and complex disease in Japan," Hiromitsu Kumada, director general of the Department of Hepatology at Toranomon Hospital Kajigaya in Kanagawa, Japan, said in the release. "High cure rates were shown in dedicated clinical trials with Maviret in Japanese patients, as well as a favorable tolerability profile, demonstrating the potential of Maviret to meet evolving unmet needs for both patients and physicians."

Maviret also offers a 12-week treatment for patients with genotype 3-6, and patients who have specific treatment challenges, the release said.

"The human, social and economic burden of HCV to individuals in Japan can be significant as the disease progresses to the later stages," Michael Severino, executive vice president of research and development and chief scientific officer at AbbVie, said in the release. "AbbVie is committed to working with health authorities to get Maviret to physicians and patients as quickly as possible so that the opportunity for virologic cure in as short as eight weeks may be a reality for the majority of people living with HCV."

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