Epclusa (sofosbuvir / velpatasvir), the first hepatitis C treatment able to cure six types of the hep C virus with high success rates against all of the six types, has been approved for use in America for all of those six types!
The hep C treatment sofosbuvir / velpatasvir (American brand name Epclusa) was approved by the U.S. Food and Drug Administration (FDA) yesterday. It was approved for the treatment of adult patients with a chronic hepatitis C virus infection, genotype 1, 2, 3, 4, 5, or 6. This approval means that it can be prescribed to those with or without liver cirrhosis and can be prescribed with or without the drug ribavirin (prescribed with ribavirin for patients with liver cirrhosis, Child-Pugh B or C).
Yesterday’s Press Releases about Sofosbuvir / Velpatasvir’s FDA Approval
- The FDA’s news release about sofosbuvir / velpatasvir’s approval, FDA approves Epclusa for treatment of chronic Hepatitis C virus infection
- The press release about the approval by Gilead, sofosbuvir / velpatasvir’s developer
Sofosbuvir / Velpatasvir (American Brand Name Epclusa)
Description: Sofosbuvir / velpatasvir is a short-course hep C interferon-free treatment that can be prescribed with or without ribavirin. It is a pill taken once a day.
It is the first once daily pill treatment for patients with hep C genotype 2 and 3, without the need for ribavirin.
Approved for in the States: Epclusa taken for 12 weeks was approved in patients without liver cirrhosis or with compensated liver cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with more serious liver cirrhosis (Child-Pugh B or C).
Common Side Effects: The most common side effects of sofosbuvir / velpatasvir are headache and fatigue. However, If it is combined with ribavirin, patients may experience side effects from the ribavirin.
Sofosbuvir / Velpatasvir in Canada
Sofosbuvir / velpatasvir isn’t approved for use in Canada yet.
Clinical Trial Results for Sofosbuvir / Velpatasvir
In Phase III clinical trials, the treatment’s safety and effectiveness as a 12 week treatment was evaluated on 1,558 patients without liver cirrhosis or with mild cirrhosis. With or without ribavirin, it cured 95–99% of those patients. In trials, it also cured 94% of those with moderate to severe liver cirrhosis.
“This drug regimen changes the standard of care in treating patients with HCV. We can now cure almost everyone with a very simple treatment,” said Dr. Jordan Feld, a liver specialist at Toronto Western Hospital.