FDA approves sofosbuvir, ushering in paradigm shift in HCV treatment

The FDA approves Gilead's (GILD) sofosbuvir for HCV.

One FDA official calls this "a significant shift in the treatment paradigm for some patients with chronic HCV" — this is the first HCV treatment to exhibit both safety and efficacy without the need for concurrent interferon treatment. (PR)

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Comments (6)
  • trstrap
    , contributor
    Comment (1) | Send Message
    I have it - I would like to be rid of it and now the cost issue. What will the treatment cost.
    6 Dec 2013, 05:23 PM Reply Like
  • Stephen Tips
    , contributor
    Comments (656) | Send Message


    I was told that I had a "high incidence of hep c anti-bodies."


    After 1.5 years of tests, I finally was directed to see the chief of hepatology at the Sylvester Center in Miami. Following additional testing, I was told that, at one time, I had contracted the disease but my body fought it off, hence the "high incidence of hep c anti-bodies." I was informed that my experience is quite rare, and the chance of relapse was less than 1%. I am fortunate.


    This approval opens the door for millions who are suffering – this is HUGE.


    I empathize with you. Hopefully insurance, in one form or another, will pay for most if not all of your treatment and you will be well.


    I wish you the best of good health, and fortune.


    6 Dec 2013, 06:12 PM Reply Like
  • GaryLee276
    , contributor
    Comments (151) | Send Message
    Same thing here Stephen.
    6 Dec 2013, 07:03 PM Reply Like
  • hneumann
    , contributor
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    There is also deleobuvir, faldaprevir and simeprevir.


    About simeprevir and sofosbuvir on 7 november:


    "Each of the two drugs is weeks from a likely approval from the U.S. Food and Drug Administration. And while the FDA will not be approving simeprevir and sofosbuvir for use in combination at this time, the findings of the COSMOS study may influence clinicians’ decisions to prescribe them together off-label, in particular for patients with more urgent needs for treatment."


    Faldaprevir and deleobuvir are not yet registered. So probably more competition for Gilead coming.
    6 Dec 2013, 07:24 PM Reply Like
  • pemarangshar
    , contributor
    Comments (14) | Send Message
    The "cost" is $87,000. The previous protocols were lower cost for prescriptions but when treatment time, specialists expenses and side effect costs are factored those prior options are more expensive. For those unable to pay Gilead has typical help you plans. Cash customers will likely received hefty discounts.


    In 1998 hep c antibodies were found in me. Doctors advise was to monitor annually as my body had fought off the virus. In early 2008 annual blood work showed a rapidly replicating hep c viral attack was underway. A 48 week regimen of interferon alpha and ribivarin cured and very nearly killed me. "Flu like" side effects is a disingenuous way of saying that nearly everyone given that treatment will either not complete the protocol or will suffer long term negative effects. Lymphoma, organ degradation and other severe challenges are dangers that are not much discussed. Residual damage to me is near zero thyroid function, a 2009 emergency gallbladderectomy with severe complications and years of recovery from the treatment protocols.


    I am blessed to be cured. Those who can achieve that goal without interferon are truly fortunate. It is exciting to see so many great companies in the race for this cure.....
    8 Dec 2013, 09:30 AM Reply Like
  • User 15332182
    , contributor
    Comment (1) | Send Message
    I was in the Gilead trial that started on Jan. 1 2013. I have advanced HepC with liver cirrhosis, scarring, but have greatly limited anything that would damage my liver for the last 30 years.


    I had failed four long-term trials with interferon and Ribiviran - with very harsh side effects - like I was coming down with a bad flu, everyday. They all failed and my viral load almost immedieately went back to where they were - 1 -5 million.


    Finally Scripps Research in La Jolla got me enrolled in the Gilead trial. It was one pill for 12 or 24 weeks - I was in the longer leg of the trial. We all had failed previous trials, and had active infections effecting our liver functions.


    I cleared the virus in the first three weeks, which blew my mind - the other trials took months to just lower my viral load to 50k or so, but then would start rising.


    With the Gilead drug it stayed at zero through the end of the 6 month trial. Four months after I stopped taking the new drug, My doctor had me tested again - still zero.


    It's a miricle. I bought their stock at $40 a share - and now it's over $70 and expected to go much higher. This is the real cure. It's not 100%, but closer than anyone else, for tough cases.
    8 Dec 2013, 10:58 AM Reply Like
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