The U.S. Centers for Disease Control and Prevention (CDC) in Atlanta has published a new interim guidance for health care professionals on the use of pre-exposure prophylaxis (PrEP) in heterosexual men and women. PrEP involves HIV-negative individuals taking the HIV drug Truvada (tenofovir + emtricitabine) to prevent them from becoming infected with HIV. Previously, the only guidance on PrEP from the CDC was for men who have sex with men.
As with the FDA-approved prescribing directions for Truvada as PrEP, the CDC is insisting that PrEP be offered only to people proved to be HIV-negative. Further, the CDC is recommending that PrEP should be targeted to individuals at very high risk for HIV infection, giving the example of someone with an HIV-positive sex partner. They also urge providers to offer PrEP in combination with other prevention methods, such as condoms, and to educate patients to take the drug daily, to ensure the best effectiveness.
Lastly, the CDC suggests that women who are pregnant or trying to conceive be offered information about the possible risks and benefits to themselves and their babies if they choose to take Truvada for PrEP.
Project Inform applauds the CDC for publishing this guidance so soon after FDA approval of Truvada for PrEP, but also hopes that a future more definitive document by the Public Health Service will offer health care providers more complete instructions on how to assess and manage HIV risks in their patients, how best to determine appropriate candidates for PrEP. Â We also hope that future document will make suggestions for which methods to support adherence might have the highest likelihood of success.
As the CDC has stated publicly upon the release of this document, more information is needed on the best way to provide PrEP in real-world settings, how acceptable PrEP will be to different populations and how well people can adhere to the medication outside of a clinical trial. Project Inform is actively engaged in monitoring and informing these demonstration projects, out of which more usual information will hopefully emerge