This approval made Epclusa the first and only global treatment for hepatitis C, the only full oral, ubiquitous, single tablet, and it was also the third hepatitis C drug based on sofosbuvir (Soffe Bbu Vee) developed by Gilead.
 

In addition, Epclusa is the first single tablet solution approved for the treatment of genotype 2 and genotype 3 hepatitis C (there is no need to combine Leigh Bhave Lin). The approval of Epclusa marks significant progress in the clinical treatment of hepatitis C. Prior to that, FDA has awarded Epclusa a breakthrough drug qualification and priority qualification.
 

The Epclusa treatment program approved by FDA is:

(1) Epclusa monotherapy for 12 weeks for hepatitis C patients without cirrhosis or compensated cirrhosis (Child-Pugh a).
 

(2) Epclusa combined with Leigh Bhave Lin (RBV) for 12 weeks for hepatitis C patients with decompensated cirrhosis (Child-Pugh B or C grade).
 

Epclusa will greatly simplify the clinical treatment of HCV and eliminate the necessity of detecting HCV genotype.
 

Epclusa (sof/vel), the first pan gene type hepatitis C cocktail therapy, will complement the current hepatitis C assets (Sovaldi and Harvoni) in Gilead, which will provide a high clinical cure rate, and is expected to simplify the treatment of hepatitis C, and more importantly, it is expected to eliminate the necessity of detecting the genotype of hepatitis C in patients.
 

Industry forecast: Epclusa (sof/vel) will become the best selling hepatitis C cocktail in history.
 

At present, there are 2 kinds of drugs, Sovaldi and Harvoni in Gilead's hepatitis C assets, and the unprecedented success of these 2 drugs has helped Gileadto lay the absolute supremacy in the field of hepatitis C treatment. Although rival ALB Ivy launched another hepatitis C cocktail therapy at the end of 2014, the Gileadhepatitis C franchise continues to control over 85% of the market share.
 

Epclusa (sof/vel) is a Gilead third sofosbuvir based hepatitis C cocktail, and the industry is very promising for the commercial prospects of the drug. Once the pan genetic type of hepatitis C cocktail is listed, it will become another heavy product of Gilead's hepatitis C assets and can be the best selling hepatitis C drug in history.