Gilead Sciences Inc.’s hepatitis C drug was approved by U.S. regulators for all forms of the viral disease, making it the first treatment with such a comprehensive label. The drug, called Epclusa, can be used by patients with any of the six genotypes of hepatitis C. Food and Drug Administration (FDA) has approved Gilead Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C).
Gilead has set a list price of $74,760 for a 12-week course of treatment. Epclusa will be priced at $74,760 for a 12-week treatment regimen, or $890 per pill. That may not seem like a huge discount over $1,000 per pill. This drug saves lives, but its very high price has kept a cure out of the hands of people who need it,”
The liver disease affects 130 million to 150 million people globally, according to the World Health Organization. The First-Ever Drug to Treat All Major Hep C Strains . Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C . While Gilead is the market leader in hepatitis C treatments, competition from Merck & Co. and AbbVie Inc. has slowed its sales. The new drug may help Gilead strengthen its lead, especially by picking up patients with genotype 3, the hardest-to-treat form of the disease, and genotype 2, which currently often requires the addition of another treatment. The liver disease affects 130 million to 150 million people globally, according to the World Health Organization.