The treatment, known under the brand name Epclusa, combines Sovaldi — approved in 2013 — with a new anti-viral generic called velpatasvir.
The FDA approved Epclusa to treat patients with and without cirrhosis, a type of liver scarring seen in patients with advanced forms of hepatitis C.
In clinical trials, Epclusa led to cure rates of 95 percent to 99 percent in patients with or without cirrhosis after 12 weeks of treatment.
Shares of Gilead rose 3.7 percent in response to news of the approval.
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