Gilead announced that the Food and Drug Administration (FDA) has approved Epclusa (sofosbuvir/velpatasvir) as a single tablet regimen for the treatment of adults with genotype 1–6 chronic hepatitis C virus (HCV) infection.
This marks the first all-oral, pan-genotypic, single tablet regimen for this indication, and the first to be approved for the treatment of HCV genotypes 2 and 3 without the need for ribavirin. Epclusa was also approved for 12 weeks in patients without cirrhosis or compensated cirrhosis (Child-Pugh A), and in combination with ribavirin for patients with decompensated cirrhosis.
Epclusa combines sofosbuvir (Sovaldi), a nucleotide analog polymerase inhibitor, and velpatasvir, a pan-genotypic NS5A inhibitor. The FDA approval was supported by data from 4 international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3, and ASTRAL-4, involving over 1,500 patients. Of the 1,035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2, and ASTRAL-3 studies, 98% achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis treated with Epclusa and ribavirin for 12 weeks achieved a high SVR12 rate (94%) vs. those who received Epclusa for 12 weeks (83%) or 24 weeks (86%). The most common side effects of Epclusa were headache and fatigue.
Epclusa was granted Priority Review and a Breakthrough Therapy designation by the FDA. Epclusa will be available as 400mg/100mg tablets in 28-count bottles.
For more information call (800) 445-3235 or visit Gilead.com.