A "New" Antiretroviral Option Quietly Enters the Market

April 25, 2011

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.

There's a new antiretroviral option out there, a 400-mg extended-release tablet formulation of nevirapine that can be dosed once daily.

However, you might not have noticed, since it's not really that new, and it's not clear that this formulation offers any significant advantages over the nevirapine we already have. Writes Keith Henry over in Journal Watch:

Issues that will temper enthusiasm for the new formulation include continued concern about serious adverse effects with nevirapine (namely, Stevens-Johnson syndrome in the general patient population, and liver toxicity in women with CD4 counts >250 cells/mm3 and men with CD4 counts >400 cells/mm3), the availability of safe and effective non-nevirapine-containing regimens, the likely approval of additional one-pill once-daily regimens (e.g., tenofovir/FTC/rilpivirine, abacavir/3TC/dolutegravir, and tenofovir/FTC/elvitegravir/cobicistat), and the possibility of nevirapine coming off patent in 2012 (which creates potential for a lower-priced generic).

Add to these issues the need to still take* the 200 mg once-daily lead in for 14 days, and one wonders how much use this "new and improved" nevirapine is going to get.

(*I know, split infinitive -- it just sounds better that way!)

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 NEJM Journal Watch. NEJM Journal Watch is a publication of the Massachusetts Medical Society.

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