US Food and Drug Administration approves Gilead's Sovaldi (sofosbuvir) for the treatment of chronic hepatitis C [ press release ]. December 6, www. gilead. com/ news / press - releases //12/ us - food -and- drug -. Sovaldi (sofosbuvir) is used to treat chronic hepatitis C virus (HCV) infection. that the U.S. Food and Drug Administration (FDA) has approved a supplemental To support these patients and their families, Gilead's U.S. Support Path® This press release includes forward-looking statements within the. Harvoni and Sovaldi were previously approved to treat HCV in adults. FDA News Release Release. The U.S. Food and Drug Administration today approved for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis Harvoni and Sovaldi are marketed by Gilead Sciences, Inc.