On July 16, 2012 the United States Food and Drug Administration (FDA) approved a change in the label for an antiretroviral combination drug called Truvada. This label change will allow Gilead Sciences Inc., the company who manufactures Truvada, to promote the drug not only as treatment for HIV but also as a means of Pre-Exposure Prophylaxis (PrEP). This means that people who are HIV negative can be offered a once-a-day pill in combination with other risk-reducing methods (condom use…etc) to increase their chances of not contracting HIV.
However, this approval has not come without controversy. Even though the drug has been proven to be effective for prevention through large controlled studies in both men who have sex with men (MSM) and couples who have different sero-status (one person is HIV-positive, the other HIV-negative),there are some who see it as a step backwards. Those opposed to the approval are worried that the endorsement of Truvada as a means of PrEP will lead to more risky behaviour, (i.e. forgoing condom use, engaging in riskier sexual activities etc…). Another troublesome possibility is an increase in antiretroviral resistant strains of the HIV virus due to a lack of treatment adherence (remembering to always take your pill as directed).
This increase in resistant strains could prove to be problematic as we have a limited arsenal of medications available. Thirdly, there is always the issue of cost, at a minimum 3600$ a year not including counselling, screening and other associated costs, this is an expensive course of action for both the patient and health care system.
So while this approval is certainly a big step forward in terms of prevention possibilities, we still need to continue the research on PrEP and its associated risk and benefits so that we can move forward in the fight against AIDS.
Cohen, J. (2012). Aids Research: FDA Panel Recommends Anti-HIV Drug for Prevention. Science , 336 (6083), 792.
Maxmen, A. (2012). Wary approval for drug to prevent HIV:US regulators seek to mitigate risks of combined pill. Nature , 487 (7407).