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Japan Okays Approves Gilead Sciences' Epclusa

Gilead Sciences Inc. (GILD) said that Japan's Ministry of Health, Labour and Welfare or MHLW has approved Epclusa (sofosbuvir 400mg/velpatasvir 100mg), a once-daily treatment for adults with chronic hepatitis C virus (HCV) infection with decompensated cirrhosis, and for patients with chronic HCV infection without cirrhosis or with compensated cirrhosis who have had prior treatment with a direct-acting antiviral therapy or DAA.

Until now, no treatment option has been available in Japan for the treatment of chronic HCV infection with decompensated cirrhosis, and there have been limited treatment options for patients with chronic HCV infection who have had prior treatment with a DAA. Epclusa offers a new option for both of these difficult-to-treat patient populations, Gilead Sciences said.

Epclusa is a combination treatment that contains sofosbuvir, an NS5B polymerase inhibitor that was approved in Japan as Sovaldi® 400 mg tablets in March 2015, and velpatasvir, an active ingredient that inhibits NS5A.

In Japan, Epclusa is indicated for the suppression of viremia in patients with chronic HCV infection. Patients with chronic HCV infection with decompensated cirrhosis should take one tablet of Epclusa once daily for 12 weeks, and patients with chronic HCV infection without cirrhosis or with compensated cirrhosis that have had prior DAA treatment experience should take one tablet of Epclusa once daily for 24 weeks, in combination with ribavirin (RBV).

The US Prescribing Information for Epclusa contains a Boxed Warning regarding the risk of hepatitis B virus reactivation in HCV/HIV co-infected patients. See below for US Important Safety Information and Indication.

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