Sovaldi Approved in Japan for Genotype 2 Hepatitis C Treatment

Japanese regulators recently approved the blockbuster hepatitis C drug Sovaldi as the first all-oral treatment regimen for genotype 2 patients in that country.

Sovaldi is made by California-based drug maker Gilead Sciences and is the first product to be marketed by the company in Japan, according a Gilead release. The once daily drug is indicated in combination with ribavirin for 12 weeks of treatment in patients with genotype 2 hepatitis C virus with or without compensated cirrhosis.

Hepatitis C is a bloodborne virus that if left untreated can lead to chronic infection resulting in serious liver damage, liver cancer or the need for a liver transplant. Sovaldi is one of the new drugs to hit the market that treats the virus faster and with higher cure rates than previous standard treatment.

An estimated 1 million people are believed to be infected with hepatitis C in Japan and about 20% to 30% have the genotype 2 strain of the virus. The country has one of the highest rates of liver cancer, attributed largely to infection of the virus, among industrialized nations, the release states.

Sovaldi’s approval will allow patients with genotype 2 of the virus to receive an all-oral treatment in 12 weeks, a shorter time than was previously available. The Gilead release states that other drug regimens that are approved in Japan to treat genotype 2 hepatitis C infection call for 24 to 48 weeks of interferon injections, which may not be suitable for many patients.

“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,” said Gilead official Norbert Bischofberger. “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.”

The data that Gilead submitted to Japanese authorities included results from a phase 3 clinical trial in Japan that involved 140 patients some of whom had previously been treated and some who had never been treated for the virus. Among that group, 96% (135 patients) who were infected with genotype 2 hepatitis C achieved sustained virologic response 12 weeks after completing therapy of an all-oral regimen of Sovaldi and ribavirin. Roughly 43% of the patients experienced adverse events including, anemia, headache, malaise, nausea and pruritus, according to Gilead.

Last fall, Gilead submitted an application to Japan’s Pharmaceutical and Medical Devices Agency for a single tablet, fixed-dose drug that combines Sovaldi (sofosbuvir) and ledipasvir for the treatment of chronic genotype 1 hepatitis C. That application is still under review, the company said.

Sovaldi is also approved for use in the United States, European Union, Australia, and Canada