New Hepatitis C Drug Approved by FDA

Taken as a pill once a day, it could make treatment for millions easier, more effective

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By HealthDay staff

HealthDay Reporter

SATURDAY, Dec. 7, 2013 (HealthDay News) -- A new hepatitis C drug that can be taken as a pill once a day was approved by the U.S. Food and Drug Administration on Friday.

The drug, called Sovaldi and made by Calif.-based Gilead Sciences Inc., works faster and should be much simpler to take for the millions of Americans who have the virus, which can destroy the liver if left untreated.

The FDA said in a statement that Sovaldi is to be taken with older drugs to treat the main forms of hepatitis C. The agency added that 3.2 million Americans have the disease, and people born between 1945 and 1965 are five times more likely to be infected.

Current treatments can take almost a year to beat back the virus, and involve weekly injections of the drug interferon, which can cause diarrhea and flu-like symptoms, the FDA said. Only about 75 percent of patients are cured with current treatments. In clinical trials, Sovaldi cured close to 90 percent of patients in just 12 weeks, when combined with the standard treatment.

Sovaldi (sofosbuvir) is the second hepatitis C drug to be approved by the FDA in the past two weeks. In November, the agency gave its blessing to Olysio (simeprevir), made by Janssen Pharmaceuticals, of Raritan, N.J.

Symptoms of hepatitis C disease may not appear until two or three decades after infection, though the virus can cause liver failure, cirrhosis and cancer, the FDA said.

Gilead Sciences said Friday that a four-week supply of the drug would cost $28,000 at the wholesale rate.

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SOURCES: U.S. Food and Drug Administration, news release, Dec. 6, 2013; Gilead Sciences, news release, Dec. 6, 2013
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