The Japanese Ministry of Health, Labour and Welfare has approved sofosbuvir to suppress viremia in patients with chronic hepatitis C virus genotype 2 infection, with or without compensated cirrhosis, according to a press release from the drug maker.
“Today’s approval represents an important step forward in the management of hepatitis C in Japan, enabling genotype 2 infected patients the opportunity of a cure in 12 weeks with an all-oral regimen that eliminates the need for interferon,” Masao Omata, MD, of the Yamanashi Prefectural Hospital Organization, said in the release.
The approval of sofosbuvir (Sovaldi, Gilead Sciences) is supported by data from a phase 3 clinical trial conducted in Japan among treatment-naive and treatment-experienced patients with HCV genotype 2 (n = 140). Ninety-six percent of these patients (n = 135) achieved a sustained virologic response after completing a 12-week regimen of sofosbuvir plus ribavirin at 600 mg/day to 1,000 mg/day, according to the release. Other phase 3 clinical trials, including FUSION and POSITRON, included HCV genotype 2 patients and positive results.
“There is a need in Japan for new HCV treatment options that are more effective and better tolerated and we have been pleased to partner with the medical community here in Japan to demonstrate the efficacy and safety of Sovaldi,” 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 Sovaldi available in Japan as quickly as possible, while simultaneously continuing to work with the agency on its review of our second application for an all-oral sofosbuvir-based regimen for the treatment of genotype 1 HCV infection.”
Sofosbuvir is indicated for use in combination with ribavirin for 12 weeks and is the first all-oral, interferon-free treatment regimen for HCV genotype 2, according to the release.
Disclosure: Omata reports board membership with Gilead Sciences; consulting relationships with Bristol-Myers Squibb, Boehringer Ingelheim and Otsuka Pharmaceutical; and speaking and teaching relationships with Bristol-Myers Squibb, Pfizer, and Roche. Bischofberger is an employee of Gilead Sciences.