Hepatitis C new drug Epclusa was approved by the United States and the European Union

From:Biological Valley Date:2017-04-20 20:58

July 9, 2016 - the ubiquitous gene type hepatitis C cocktail therapy (Epclusa) developed by Gilead, the absolute hegemon in the field of hepatitis C, has achieved a major milestone in the United States and EU regulation. In the US, FDA approved Epclusa for the treatment of all 6 genotypes of hepatitis C at the end of last month. And recently, Epclusa has been unsuspense with the approval of the European Commission (EC) for the treatment of all 6 genotypes of hepatitis C.
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 Gillie.
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 treatment program approved by Epclusa 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 (sof/vel, 400mg/100mg) is a diurnal pan gene type hepatitis C cocktail therapy, developed for all 6 genotypes (GT-1, -2, -3, -4, -5, -6) hepatitis C patients. The cocktail is made up of Gillie's listed hepatitis C star drug Sovaldi (sofosbuvir) and another antiviral drug velpatasvir. Among them, sofosbuvir is a nucleoside analogue polymerase inhibitor, while velpatasvir is a ubiquitin NS5A inhibitor.