The U.S. Food and Drug Administration (FDA) today announced that a new treatment for hepatitis C has been approved.
The drug, marketed as Sovaldi, is now approved for the treatment of chronic hepatitis C virus (HCV) - the second such drug in the past month to be approved by the FDA. HCV is a chronic viral infection that causes inflammation of the liver. The disease can cause cirrhosis of the liver or even liver failure in some cases. Sovaldi stands out as the first drug approved to treat HCV without interferon also being necessary.
“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Dr. Edward Cox, director of the Office of Antimicrobial Products at the FDA.
Sovaldi was approved this week following six clinical trials of the drug. During the trials, nearly 2,000 patients with HCV (and some with HIV) were given Sovaldi. The trials demonstrated that Sovaldi is effective in treating HCV and that even patients with liver cancer can use the drug.
The drug works by blocking a protein that HCV needs to replicate itself and is meant to be used as part of an antiviral treatment program involving other drugs. Sovaldi is most likely to be used in combination with ribavirin and peginterferon-alfa.
Sovaldi is one of the FDA's "breakthrough therapy" drugs, a designation meaning a drug provides a substantial improvement over existing treatments for life-threatening diseases. Drugs designated as such can be fast-tracked for FDA approval, and Sovaldi is the third breakthrough therapy drug to be approved.