FDA Approval of Drug to Prevent HIV Infection Historic Step in Fight to End HIV/AIDS Epidemic

The following is a statement from the National Minority AIDS Council’s Director of Treatment Education, Adherence and Mobilization Moises Agosto:

Washington, DC – “Today’s historic announcement by the U.S. Food and Drug Administration (FDA) approving the use of Truvada (emtricitabine/tenofovir disoproxil fumarate) to prevent HIV infection is particularly welcome news.  For the first time, there is now a pill that can be prescribed to HIV-negative individuals at increased vulnerability for contracting the virus that can significantly reduce their risk of infection.  Known as pre-exposure prophylaxis (PrEP), this exciting new intervention has the potential to make significant inroads in the fight to bring an end to the HIV/AIDS epidemic.

“While PrEP shows substantial promise as a supplement to current HIV prevention efforts, it is by no means a panacea and is only effective when used in conjunction with traditional prevention and risk reduction strategies, such as condom usage.  Anti-retroviral medications, like Truvada, are extremely powerful drugs with the potential for serious side effects.  As such, PrEP should only be used by individuals who are highly vulnerable to HIV infection, including those in sero-discordant couples, sex workers and gay men.  Its efficacy is also directly related to an individual’s adherence to a regimen, and should only be used by those who can commit to taking it regularly.  Finally, use of PrEP by individuals who may already be HIV-positive could increase the risk of drug resistance.

“Today’s approval of Truvada for use as PrEP is only the first step in successfully implementing this exciting new intervention.  We must now work to ensure that those who can benefit from its use will be able to safely access it.  Gilead Sciences, the maker of Truvada, and the FDA have already developed resources to educate physicians and prescribers about the effective use of PrEP.  Beyond these resources however, treatment education initiatives must be developed to assist community based organizations and health clinics to develop capacities to successfully incorporate PrEP into culturally competent counseling and adherence programs.

“In recent years, there have been a number of promising developments in biomedical interventions – from treatment as prevention and pre-exposure prophylaxis to microbicides and vaccine research.  These advances have resulted in the greatest expansion of HIV prevention tools than at any other time in the history of this epidemic.  Coupled with the reforms included in the Patient Protection and Affordable Care Act as well as the National HIV/AIDS Strategy, we are in a position for the first time in over three decades to finally end this epidemic.  Today’s decision is another important step in realizing that goal.”


Contact:  Kyle Murphy, (202) 483-6622 ext. 333