5 August 2016 - Sofosbuvir with velpatasvir was originally granted fast track designation by the FDA on 30 September 2013 and was granted breakthrough therapy designation for genotypes 1, 3, 4, 5 and 6 treatment naïve patients on 22 April 2014.

Due to the approval and availability of safe and effective therapies to treat genotype 1 HCV infection, the FDA rescinded breakthrough therapy designation on 1 April 2015. The FDA and Gilead agreed an unmet medical need for genotypes 3, 4, 5 and 6 HCV infections still exists. As a result, Gilead submitted a new request for breakthrough therapy for the treatment of genotype 3, 4, 5 and 6 HCV infection in treatment naïve patients. This request was granted on 15 May 2015.

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