An advisory panel for the U.S. Federal Drug Administration (F.D.A.) voted 19-3 to recommend the use of Truvada, a combination antiretroviral drug, for the prevention of HIV among people at high risk of infection. Although this is not a full F.D.A. approval, it paves the way for a decision in mid-June. The endorsement follows a groundbreaking study in 2010 that found a 44 percent reduction of infection risk among men who have sex with men who took Truvada and a 92 percent risk reduction of infection risk for those who took the pill every day (only about 10 percent of the men in the study adhered to the daily regimen). Reuters writes that the panel’s recommendation “has raised hopes that the United States could stem the growth of a national HIV epidemic that has stubbornly generated 50,000 new infection cases a year for the past two decades.”
The panel only endorsed the use of Truvada for the most at risk populations–men who have sex with men, serodiscordant couples (where one partner is positive and the other negative), and sex workers, for example. Doctors have already been prescribing Truvada for HIV prevention off-label, which is legal in the United States as long as a drug has been F.D.A.-approved. There are concerns, however, about the use of powerful antiretroviral drugs, the risk of drug-resistant strains due to non-adherence to the daily dose, and higher risk activities, such as forgoing condoms, if the drug is officially approved. The New York Times has more.
Arguments that people at risk of HIV infection will take bigger chances with their health if given a preventative measure is as nonsensical as arguing that teaching teens about condom use will lead to greater instances of pregnancy and sexually-transmitted infections: one study found that American teenagers who received comprehensive sex educations had a 50 percent lower risk of teen pregnancy than those who had abstinence-only education. Of course, cost is another issue–an annual course of preventative pills would cost about US$11,000-14,000–and the implications of driving up demand for such drugs when there are millions of people around the world without access to to Truvada and other ARVs to treat HIV, as Business Week points out. That’s on Gilead, the company that manufactures Truvada, and speaks to a larger problem about patents, generic drugs, and Big Pharma that I won’t get into today.
On the other hand, as the BBC notes, adherence could be a real challenge. As Karen Haughey, a nurse, told the advisory panel: “In my eight years, not one patient that I’ve cared for has been 100% adherent.” Although there is truth in her statement, it has been heard many times before, such as the argument that antiretrovirals should not be dispensed in sub-Saharan Africa: I doubt there are few people who make that assertion now. Drug resistance due to inability or choice of not adhering to complex regimens of expensive drugs with difficult side effects has been a challenging issue since the introduction of antiretroviral drugs, but it has not been the definitive experience of treating and managing HIV. Patients are not always going to take every single pill every day–for a wide variety of diseases or preventative therapies–but even without full adherence, there is a risk reduction. Education and support will be key to adherence (and to practicing safe sex).
Overall, the F.D.A.’s approval of Truvada as a prophylaxis against HIV infection would be just one more small victory in the fight against HIV/AIDS within the United States. Global prevention, diagnosis, and treatment of HIV/AIDS is a complex, multi-armed effort, and aggressive education programs, family and institutional support, behavioral and cultural change, better health clinics and health care workers, more and cheaper drugs, increased funding, and a host of other things will be needed to turn the tide. We’ve seen great progress in the last decade. This is not a panacea, but it is one step closer and one that the F.D.A. should take.
Header photo by Fillmore Photography, via Flickr, CC BY 2.0.
