AUGUST 2, 2017

FDA Expands Indication Labeling for Epclusa to Treat Chronic HCV in HIV Coinfected Patients

By IDSE News Staff

The FDA approved updated labeling for sofosbuvir-velpatasvir (Epclusa, Gilead), the first all-oral, pan-genotypic, once-daily single-tablet regimen for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients coinfected with HIV.

Sofosbuvir-velpatasvir received regulatory approval for the treatment of adults with genotype 1 to 6 chronic HCV infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis in