Japan approves Harvoni for HCV

The Japanese Ministry of Health, Labour and Welfare has approved Harvoni for the treatment of chronic hepatitis C genotype 1 infection in adults, including those with compensated cirrhosis, according to a press release from the manufacturer.

The combination pill, which is the first combination pill for treatment of chronic HCV virus genotype 1 that does not require interferon or ribavirin for administration, combines ledipasvir (Gilead) and sofosbuvir (Sovaldi, Gilead).

Japan has one of the highest rates of liver cancer of any industrialized country, according to the release, and it is primarily due to HCV. There are reportedly more than 1 million people in Japan with HCV, of which 70 to 80% have genotype 1.

“[The] approval significantly advances the standard of care for chronic hepatitis C in Japan, as it eliminates the need for interferon and ribavirin, which can be difficult to take and to tolerate, and offers the majority of people with genotype 1 infection to be cured in as little as 12 weeks with a once-daily pill,” Masashi Mizokami, MD, PhD, of The Research Center for Hepatitis and Immunology at the National Center for Global Health and Medicine in Ichikawa, Japan, said in the release.

The approval stems from results from the ION-1, ION-2 and ION-3 phase 3 studies, in which Harvoni was evaluated at 8, 12 or 24 weeks of treatment among treatment-naive patients or those with HCV genotype 1 who previously failed treatment. The overall SVR12 rates across all three trials ranged between 94 and 99%.

“We are pleased to have partnered with the medical community in Japan to demonstrate the safety and efficacy of two significant advances in the treatment of chronic hepatitis C — Harvoni for genotype 1 infection and Sovaldi for genotype 2 infection, which was approved just 3 months ago,” Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead, said in the release. “We look forward to making Harvoni available in Japan as quickly as possible.”

The FDA approved Harvoni for the treatment of HCV genotype 1 in October 2014.

Disclosure: Bischofberger reports being employed by Gilead. Healio.com/Hepatology was unable to confirm Mizokami’s financial relationships at the time of publication.