Japan Approves Harvoni for Treatment of Hepatitis C

Gilead Sciences recently announced that Japanese regulators have approved its single-tablet combination drug Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) for the treatment of hepatitis C infection in adults, after the company submitted data showing a 100% cure rate among a group of patients in a Japanese phase 3 clinical trial.

The Japanese Ministry of Health, Labour, and Welfare approved Harvoni for the treatment of adult patients who are chronically infected with hepatitis C genotype 1, with or without compensated cirrhosis, Gilead said in a statement. The drug is taken once a day for 12 weeks.

In April, Gilead won Japanese approval of its blockbuster drug Sovaldi, which was the company’s first product to be marketed in that country. Harvoni combines 400 mg of the nucleotide analog polymerase inhibitor sofosbuvir and 90 mg of the NS5A inhibitor ledipasvir.

Harvoni eliminates the need for interferon and ribavirin for patients with genotype 1 of the virus, Gilead said in the statement. Traditional treatment for hepatitis C involved interferon and ribavirin, which often resulted in serious side effects.

Hepatitis C is a bloodborne virus that can remain undetected in the body for years. If left untreated it can lead to serious liver damage as well as liver cancer or the need for a liver transplant.

An estimated 70% to 80% of the 1 million people believed to be infected in Japan have the genotype 1 strain of the virus, according to Gilead. Among industrialized nations, Japan has one of the highest rates of liver cancer, attributed largely to infection of the virus, the statement said.

“Harvoni is a safe, simple and well-tolerated treatment,” Norbert Bischofberger, Gilead’s executive vice president of research and development, said in the statement. “With cure rates of up to 100 percent and without the need for interferon or ribavirin, it offers genotype 1-infected patients a high likelihood of cure.”

The data that Gilead submitted to Japanese authorities included results from a phase 3 clinical trial (GS-US-337-0113) in Japan that involved 318 patients with genotype 1 hepatitis C, some of whom had previously been treated and some who had never been treated for the virus. The patients were randomized into two groups, with 157 patients receiving just Harvoni and 161 patients receiving Harvoni plus ribavirin, according to Gilead. Among all patients enrolled, 34% were 65 years old or older and 23% had cirrhosis of the liver.

Out of 78 patients who took Harvoni without ribavirin for 12 weeks, 100% of those who were treatment-naïve and 100% of those who were treatment-experienced achieved sustained virologic response 12 weeks after they completed therapy. Adverse events that patients experienced were generally mild and the most common included nasopharyngitis (29%), headache (7 %), and malaise (6%).

Gilead said it also submitted data from three phase 3 studies (ION-1, ION-2 and ION-3) that evaluated 8, 12, or 24 weeks of treatment with Harvoni among genotype 1 HCV patients from the United States, Europe, and Puerto Rico.

Harvoni is also approved for use in the United States, European Union, and Canada.