In the recent post on the approval of generic Combivir -- and the lack of availability of generic Epivir (lamivudine, 3TC), which was both anticipated and likely to be more useful -- I speculated there were several possible causes of this surprising turn of events.
If your patient population is anything like mine, then you see a lot of active drug users. My dear friend, Suzanne Carlberg-Racich, Ph.D., M.S.P.H., reminded me of my faux pas immediately after the article was published. I'd like to share the ensuing conversation with you, because it includes some very good tips.
Periodically I like to give an informal quiz to the medical students about HIV epidemiology. It's a multiple choice question that goes something like this:
FDA granted approval for a generic formulation fixed dose combination of lamivudine and zidovudine tablets, 150 mg/300 mg, two nucleoside analogue reverse transcriptase inhibitors, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection ... FDA has determined that the generic formulation is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Combivir Tablets...
FDA approved Edurant (rilpivirine) 25 mg tablets, a new non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV. Rilpivirine is an antiviral drug that helps to block reverse transcriptase, an enzyme necessary for HIV replication. The recommended dose of rilpivirine is one 25 mg tablet once daily taken orally with a meal.
Maybe I'm being presumptuous here, but one of these -- virologic suppression -- completely blows the rest of them away. Sure, the others are worthwhile, but data linking them to improved outcomes for people with HIV are either pretty weak (adherence counseling, flu vaccine) or nonexistent (toxoplasmosis serology).
The results of the HPTN Study 052 -- which randomized 1,763 serodiscordant couples to early vs delayed ART to evaluate whether this reduced the risk of HIV transmission -- have just been released:
"Deep salvage patients no longer exist. The ones in that situation are already dead or have responded to the latest HIV antiretrovirals."
There's a new antiretroviral option out there, a 400-mg extended-release tablet formulation of nevirapine that can be dosed once daily.
On the heels of last month's report of HIV transmission from an organ donor -- covered here in Journal Watch -- comes this remarkable article in The New York Times about lifting the ban on organ donation from donors known to be HIV positive.