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New FDA HIV Drug Approvals Unlikely to Have Much Impact, Unless ...

September 28, 2014

Paul E. Sax, M.D.

Paul E. Sax, M.D., is director of the HIV Program and Division of Infectious Diseases at Brigham and Women's Hospital in Boston.

If you're an ID doc based in the U.S., you probably received notice last week that two new HIV drugs were approved -- cobicistat and elvitegravir.

And if you're wondering what the big deal is, welcome to the club. In fact, the Canadians beat us to the punch with more significant approval, the co-formulated darunavir/cobicistat, branded as Prezcobix -- which sounds like one favorite British breakfast cereal.

For the record, here are a few reasons why the FDA approval of elvitegravir and cobisistat will likely have little short-term effect on clinical practice:

  • Elvitegravir is already available as part of TDF/FTC/EVG/COBI.
  • Cobicistat is already available as part of the same single tablet regimen.
  • If not coformulated, elvitegravir alone has no major advantages over raltegravir and dolutegravir.
  • If not coformulated, cobicistat alone has no major advantages over ritonavir. (Though I gather the pill is smaller. Haven't seen it yet.)

But -- what if they cost less? Especially a lot less?

Then maybe.

Paul Sax is Clinical Director of Infectious Diseases at Brigham and Women's Hospital. His blog HIV and ID Observations is part of Journal Watch, where he is Editor-in-Chief of Journal Watch AIDS Clinical Care.

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This article was provided by Journal Watch. Journal Watch is a publication of the Massachusetts Medical Society.
 

 

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