The Centers for Disease Control and Prevention has released guidelines for clinicians prescribing antiretroviral medicine to prevent acquisition of HIV in heterosexual men and women, saying daily doses of Truvada can be safe and effective in reducing risk of infection. The guidelines, released in the agency’s August 10 Morbidity and Mortality Weekly Report, emphasize that PrEP be “targeted to people at very high risk of HIV acquisition . . . especially uninfected persons whose regular sexual partners are known to have HIV infection.” The agency issued guidelines for preexposure prophylaxis use of antiretrovirals for men who have sex with men in January 2011, following a study on PrEP among men who have sex with men released the previous November.
The new guidelines follow four studies on PrEP among heterosexual adults, and the Food and Drug Administration’s approval of the antiretroviral drug Truvada to prevent HIV acquisition among uninfected heterosexual men and women and men who have sex with men. They include an evaluation of risks during pregnancy, noting that women who became pregnant during the PrEP studies were discontinued from drugs. The authors of the guidelines looked at data from studies of HIV-positive women taking the medicine to prevent perinatal transmission, and a registry of data on antiretroviral use during pregnancy and found no evidence of risks to fetuses. The authors also say that use of PrEP may be particularly valuable to pregnant women, as the risk of HIV acquisition increases during pregnancy.The guidelines include telling women that effects of PrEP on fetuses has not been fully determined, but that no ill effects have been found. PrEP should not be prescribed to women who are breastfeeding, the guidelines say.
The guidelines include prescription of no more than a 90-day supply at a time, continued HIV testing, and pregnancy tests at each followup appointment for women.
The CDC and other public health service agencies are developing a set of guidelines on PrEP as part of a comprehensive HIV prevention effort, and will continue to update their recommendations.