FOSTER CITY, Calif. — The Food and Drug Administration has approved a new drug for hepatitis C made by Gilead Sciences, the drug maker said Friday.
Gilead announced the approval of Sovaldi (sofosbuvir) tablets in the 400-mg strength, intended to be taken once per day for chronic hepatitis C as part of a combination antiviral treatment regimen by patients with genotypes 1, 2, 3 and 4 of the virus. The FDA gave Gilead priority review and breakthrough therapy designations for the drug, which it does for experimental medications that may offer major advances in treatment over existing options.
According to Gilead, patients with genotype 1 or 4 should take the drug with pegylated interferon alfa and ribavirin for 12 weeks; those with genotype 2 should take it with ribavirin for 12 weeks; and those with genotype 3 should take it with ribavirin for 24 weeks. Chronic hepatitis C affects about 4 million people in the United States, mostly those born between 1945 and 1965, and it is the leading cause of liver cancer and liver transplants, in recent years surpassing HIV and AIDs as a cause of death. The current standard of care involves up to 48 weeks of treatment with pegylated interferon and ribavirin.
"I believe that Sovaldi will have a major impact on public health by significantly increasing the number of Americans who are cured of hepatitis C," Weill Cornell Medical College researcher and chief investigator in the Sovaldi clinical trials Ira Jacobson said. "In clinical studies, Sovaldi in combination with other agents achieved very high cure rates while shortening the duration of treatment to as little as 12 weeks and reducing or completely eliminating the need for interferon injections, depending on the viral genotype."