On July 16th, 2012, the U.S. Food and Drug Administration (FDA) approved the first brand of HIV medication, Truvada, as Pre-Exposure Prophylaxis (PrEP). Truvada as PrEP is anti-retroviral medication taken daily by HIV-negative individuals who are at high-risk of contracting HIV. Truvada as PrEP seems to be a promising development to existing prevention strategies to help reduce HIV transmission. The current market drug, Truvada, is a combination of two HIV anti-retroviral medications, Tenofovir and Emtricitabine (TDF+FTC), which work in conjunction to obstruct the replication of the virus. Prior to FDA approval, The Center for Disease Control (CDC) conducted several trial studies that focused on the effectiveness of Truvada as PrEP for particular at-risk demographics. These studies indicate that daily dosing of this anti-retroviral combination can be successful at reducing HIV transmission. They also highlight associated advantages and limitations in Truvada as PrEP, as well as identify for whom this prevention strategy is currently being recommended.
The Pre-Exposure Prophylaxis Initiative Study (iPrEX), the first clinical trial of Truvada, was launched in November, 2010 and is being used as the reference point for the formation of recent CDC and physician guidelines. Participants were HIV-negative men who have sex with men (MSM) and male-to-female transgendered individuals who reported high-risk sexual behavior within the six months preceding the study. The results showed an average of 43% additional protection for MSM who adhered to PrEP in combination with continued HIV testing, risk reduction counseling, and condom use. Further studies have been performed that focused on the drug’s ability to decrease HIV acquisition among heterosexual individuals; however, no CDC interim guidelines have been released. Therefore, Truvada as PrEP currently is being recommended as a prevention strategy for MSM at high-risk of HIV transmission.
Although Truvada as PrEP provides increased protection against HIV transmission, an overarching concern that individuals will use Truvada to supplement other safer sex practices undoubtedly exists. Additional critical concerns around this prevention strategy include the drug’s high cost, medication adherence, and potential side effects.
In short, Truvada as PreP is not a miracle drug, but has notable potential to decrease HIV transmission. Its efficacy is optimized with medical oversight and patient adherence, and in combination with other prevention strategies. For this reason, Truvada as PrEP is FDA approved with a Risk Evaluation and Mitigation Strategy. Under this mandate, health care providers will educate users about adhering to its specific dosing schedule and continuing safer sex practices rather than relying on the drug as their primary source of prevention.