Hepatitis C drug Sovaldi approved by FDA
WASHINGTON – Federal health officials have approved a highly anticipated hepatitis C drug from Gilead Sciences Inc. that is expected to offer a faster, more palatable cure to millions of people infected with the liver-destroying virus.
The Food and Drug Administration said Friday it approved the pill Sovaldi in combination with older drugs to treat the main forms of hepatitis C that affect U.S. patients.
Current treatments for hepatitis C can take up to a year of therapy and involve weekly injections of a drug that causes flu-like side effects. That approach only cures about three out of four patients. Sovaldi is a daily pill that in clinical trials cured roughly 90 percent of patients in just 12 weeks when combined with the older drug cocktail.
Between 3 million and 4 million Americans are estimated to carry the blood-borne virus, though most do not even know they are infected. Hepatitis C symptoms may not appear until two or three decades after infection, though the virus can cause liver failure, cirrhosis and cancer if left untreated.
Gilead said Friday it would price the drug at $84,000 for one 12-week supply. Patients with a less common subtype of the disease may need to take the drug for 24 weeks. Drugs already on the market run between $25,000 and $50,000 for a course of treatment.
The approval comes as the federal government urges all baby boomers to get tested for the disease. People born between 1945 and 1965 are five times more likely than other age groups to have hepatitis C, with many having contracted the virus by sharing needles or having sex with an infected person in their youth.
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