New, expensive pill may aid Hepatitis C treatment
Posted: Sunday, December 8, 2013 6:00 pm
The Food and Drug Administration on Friday approved a pill that is expected to make the treatment of hepatitis C less onerous, shorter in duration and more effective.
The drug, Sovaldi, from Gilead Sciences, will allow some patients infected with the liver-destroying virus to be treated only with pills, doing away with weekly injections of a drug that can have debilitating side effects.
“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.
But the greater convenience and effectiveness comes at a price. Gilead said the wholesale cost of Sovaldi, which is known generically as sofosbuvir, would be $28,000 for four weeks, or $1,000 per daily pill. That translates to $84,000 for the 12 weeks of treatment recommended for most patients, and $168,000 for the 24 weeks needed for a hard-to-treat strain of the virus.
The Initiative for Medicines, Access and Knowledge, a legal group based in New York, recently filed a motion to try block patenting of the drug in India. If it succeeds, generic manufacturers in India would be able to manufacture cheap copies of the drug for distribution there and in some other developing countries.
Gilead said the price was fair given the drug’s higher cure rate and that the total cost for the 12-week regimen was “consistent with, and in some cases lower than” the cost of some other regimens for hepatitis C.
Some 3 million to 4 million Americans, many of them in middle age, are believed to have a chronic hepatitis C infection, though many do not know it. The virus slowly damages the liver, leading to cirrhosis and in some cases to liver cancer. But it often takes decades before any damage is noticeable, and many people never experience a problem.
Globally, at least 150 million people have hepatitis C.
Sales are expected to be strong from the start, because many patients, on the advice of their doctors, have been putting off starting treatment until Sovaldi became available.
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