Of the HIV medications in development with potential activity against highly resistant HIV (i.e., patients with GSS=0), two may become available within the next year: ibalizumab (formerly TNX-355), a monoclonal antibody currently under development by TaiMed Biologics, and dolutegravir (formerly GSK1349572), a second-generation integrase inhibitor made by ViiV Healthcare).
The studies on abacavir and its potential association with increased cardiovascular risk have been inconsistent ever since the news first broke at CROI 2008. But recently the data have been swirling around so fast and furious that it seems appropriate to take out this famous Greek epithet.
Every spring, on the white, sandy beaches of the Florida Panhandle, an unlikely gathering takes place. On that narrow strip of land, between the Gulf of Mexico and Choctawhatchee Bay, 450 HIV-positive men and women from around the country, but mostly from the Southeast, come together amidst occasional spring breakers for a weekend of socializing, education, some silliness, a few tears, and just plain fun.
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: