F.D.A. Approves Pill to Treat Hepatitis C

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    Dec 07, 2013 4:00 PM GMT
    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 at least some patients infected with the liver-destroying virus to be treated with pills only, 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 F.D.A.

    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.

    “This is unbearable to the health care system and it is completely unjustified,” said Michael Weinstein, president of the AIDS Healthcare Foundation, which runs treatment clinics in the United States and abroad and has previously clashed with Gilead on the price of its drugs for H.I.V.

    The Initiative for Medicines, Access and Knowledge, a legal group based in New York, recently filed a motion to try to block patenting of the drug in India. If it succeeds, generic manufacturers in India will 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. It said it would offer financial assistance to some patients.

    Some three million to four 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.

    http://www.nytimes.com/2013/12/07/business/fda-approves-pill-to-treat-hepatitis-c.html

  • hebrewman

    Posts: 1367

    Dec 07, 2013 10:27 PM GMT
    thank you big pharma. for fucking over the rest of the planet. i do not have hep c, but, as a lark, i called my insurance provider (anthem blue cross/blue shield)today to see if they would cover this. the rep on the other end of the phone not only laughed out loud, but, she said that it will not be in anyone's 'formulary' for at least a year, if ever. nice. really nice.
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    Dec 08, 2013 3:54 PM GMT
    HEBREWMAN saidthank you big pharma. for fucking over the rest of the planet. i do not have hep c, but, as a lark, i called my insurance provider (anthem blue cross/blue shield)today to see if they would cover this. the rep on the other end of the phone not only laughed out loud, but, she said that it will not be in anyone's 'formulary' for at least a year, if ever. nice. really nice.



    There is an effort to keep the drug from being patented in India so that a cheaper generic version will be available. Fingers crossed...

    The NY Times article:

    http://www.nytimes.com/2013/12/07/business/fda-approves-pill-to-treat-hepatitis-c.html?hpw&rref=health&_r=0

    The Initiative for Medicines, Access and Knowledge, which is trying to block the patent in India:

    http://www.i-mak.org/sofosbuvir/
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    Dec 08, 2013 4:19 PM GMT
    HEBREWMAN saidthank you big pharma. for fucking over the rest of the planet. i do not have hep c, but, as a lark, i called my insurance provider (anthem blue cross/blue shield)today to see if they would cover this. the rep on the other end of the phone not only laughed out loud, but, she said that it will not be in anyone's 'formulary' for at least a year, if ever. nice. really nice.

    If Obama's Affordable [sic] Care Act had been written by anyone with real brains, and if Obama had not given drug companies everything they wanted, getting this (expensive drug) would not be so problematic. It will probably cost at least 50% less in Europe, so there might be a black market in the imported drug.