What is PrEP?
The term Pre-Exposure Prophylaxis (PrEP) refers to an HIV prevention practice in which persons not infected with HIV who are at high risk of the disease take antiretroviral medication in an attempt to lower their chances of becoming infected if exposed.
To date, PrEP is still a subject of research. Studies have indicated that it may become an effective prevention strategy for men who have sex with men (MSM) and sero-discordant heterosexual men and women.
In July 2012, the Food and Drug Administration (FDA) approved Truvada for the use of prevention of HIV in high-risk populations. In January 2011CDC released Interim Guidance for physicians electing to prescribe PrEP for HIV prevention among MSM and heterosexual adults.
In November 2010, the National Institutes of Health (NIH) announced the results of the iPrEx clinical trial, a large, multi-country research study examining PrEP. The study found that daily oral use of tenofovir plus emtricitabine (TDF/FTC, brand name Truvada) provided an average of 44% additional protection to men who have sex with men (MSM) who also received a comprehensive package of prevention.
In July 2011, a study by the Centers for Disease Control and Prevention (CDC) called the TDF2 study, provided evidence that a daily oral dose of antiretroviral drugs used to treat HIV infection can reduce HIV acquisition among uninfected individuals exposed to the virus through heterosexual sex.
In July 2011, a University of Washington study called Partners PrEP, found that two separate antiretroviral regimens – tenofovir and TDF/FTC – significantly reduced HIV transmission among sero-discordant couples, in which one partner is infected with HIV and the other is not (by 62 % and 73%, respectively). CDC co-managed two of the nine sites for this study.
In 2011, an NIH prevention clinical trial study called FEM-PrEP was halted early due to an independent monitoring committee concluding that the study was unable to demonstrate the effectiveness in preventing HIV infection in women enrolled in the trial.
In March 2014, the International Conference on Retroviruses and Opportunistic Infections (CROI) held in Boston, Massachusetts, released a number of new studies and data on PrEP:
What does it mean for my Practice?
In July 2012, the Food and Drug Administration (FDA) approved Truvada for the use of prevention of HIV in high-risk populations. The announcement signifies the approval of first medication available for PrEP in the United States.
In August 2012, the CDC released interim guidance for clinicians considering the use of daily oral antiretroviral pre-exposure prophylaxis (PrEP) for preventing HIV infection in their heterosexually active patients. The guidance complements the PrEP recommendations released in January 2011 for MSM and also provides guidance for heterosexual women and men, as well as a number of new recommendations for women of reproductive age and for couples in which one partner is HIV-positive and the other HIV-negative.
Key points from the interim guidance published in the CDC's Morbidity and Mortality Weekly Report (MMWR) include:
- PrEP should be targeted to individuals at very high risk for HIV infection, such as those whose regular sex partner is HIV-infected.
- It is critical that those using PrEP adhere consistently to the daily medication regimen.
- Clinicians should inform women considering PrEP who may become pregnant that the safety of TDF/FTC for infants exposed during pregnancy has not been fully assessed, but there is also no evidence of harm. Women who are breastfeeding should not use PrEP.
- PrEP is not a stand-alone solution: It should be delivered as part of a comprehensive package of prevention services, including counseling to reduce risk behavior and encourage adherence to the daily pill regimen, ready access to condoms and management of other sexually transmitted infections.
- Individuals prescribed PrEP must be confirmed to be HIV negative prior to use, and their HIV status, experience of side effects, medication adherence, and risk behaviors must be monitored regularly during use.
The CDC has indicated that they will release Final Guidelines on the use of PrEP in accordance with available data.
The subject of PrEP as a policy issue is currently evolving debate in the scientific world. For more information on the subject, please visit our PrEP Policy Page, under the AAHIVM Policy and Advocacy tab.