U.S. Government Updates Guidelines for HIV Post-Exposure Prophylaxis

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The U.S. Centers for Disease Control and Prevention (CDC) and Department of Health and Human Services (DHHS) in April issued their latest guidelines for non-occupational post-exposure prophylaxis (PEP) for people potentially exposed to HIV through sex or shared injection equipment. The update includes new antiretrovirals approved since the last revision, with the preferred regimen now being raltegravir (Isentress) or dolutegravir (Tivicay) plus tenofovir/emtricitabine (the drugs in Truvada).

The Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV -- United States, 2016 complement the Updated US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis, which focus on exposures occurring in the course of health care or emergency services work.

The new non-occupational PEP -- known as nPEP -- guidelines revise the previous version issued in 2005. The update incorporates additional evidence regarding use of nPEP from animal studies and human observational studies, as well as consideration of antiretrovirals approved over the last decade, some of which have improved tolerability.

According to the new guidelines, health care providers should promptly evaluate people who seek care within 72 hours after a potential non-occupational exposure that "presents a substantial risk for HIV acquisition."

The guidelines state that nPEP is recommended "when the source of the body fluids is known to be HIV-positive and the reported exposure presents a substantial risk for transmission." It is not recommended "when the reported exposure presents no substantial risk of HIV transmission" or if care is sought more than 72 hours after a potential exposure. A case-by-case determination is recommended "when the HIV infection status of the source of the body fluids is unknown and the reported exposure presents a substantial risk for transmission if the source did have HIV infection."

Ideally, patients should receive a rapid combined HIV antigen/antibody or antibody blood test. But if rapid test results are unavailable and nPEP is otherwise indicated, it should be started without delay, and can be discontinued if the person is later determined to either already have HIV infection or the source is found not to have HIV.

The guidelines recommend that everyone offered nPEP should be prescribed a 28-day course of a 3-drug antiretroviral regimen. The preferred regimen for otherwise healthy adults and adolescents consists of the integrase inhibitors raltegravir or dolutegravir plus tenofovir/emtricitabine. Ritonavir-boosted darunavir (Prezista) plus tenofovir/emtricitabine is an alternative regimen for this group. Other regimens are listed for exposed children, people with decreased kidney function, and pregnant women.

All people evaluated for nPEP should also receive prevention, treatment, and supportive care for other exposure-associated health risks including bacterial sexually transmitted infections, hepatitis B and C, traumatic injuries, and pregnancy. The guidelines include updated antimicrobial regimens for post-exposure prevention of other STIs.

Finally, people seeking nPEP who report behaviors that place them at ongoing risk for HIV exposure -- such as those who regularly have sex without condoms or people who inject drugs -- should receive risk-reduction counseling and services, including consideration of pre-exposure prophylaxis (PrEP). The guidelines offer a suggested procedure for transitioning people from nPEP to PrEP using once-daily tenofovir/emtricitabine without a third agent.

5/10/16

Reference

Centers for Disease Control and Prevention. Updated Guidelines for Antiretroviral Postexposure Prophylaxis After Sexual, Injection Drug Use, or Other Nonoccupational Exposure to HIV -- United States, 2016. April 18, 2016.