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The first comprehensive CDC clinical practice guidelines for PrEP detail updated procedures for using HIV prophylaxis. Truvada (tenofovir disoproxil fumarate/emtricitabine), also referred to as TDF/FC, is the only drug approved by the FDA for this purpose. The HIV epidemic in the United States continues to grow, with approximately 50,000 new infections occurring annually. Preventing transmission of sexually acquired HIV-1 is therefore vital.
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Statistics from 2010 showed that 63% of the estimated 47,500 new infections were attributed to male-male sexual activity without injection drug use, 4% to male-male sexual activity with injection drug use, 25% to male-female sexual contact without injection drug use, and 8% to injection drug use. The figures showed the strong need for additional methods of HIV prevention to help prevent infection among those who are at higher risk.
Preexposure prophylaxis, or PrEP, can help those who do not have HIV protect themselves from an HIV infection. The PrEP combination pill contains two HIV medicines that can help stop the virus from establishing an infection. High adherence is key for effectiveness, so a strict routine of taking daily oral PrEP with the fixed-dose combination of tenofovir disoproxil fumarate and emtricitabine is necessary. When using PrEP, patients should also be involved with other effective risk-reduction services and practices.
PrEP may be considered for individuals who are HIV-negative and at substantial risk for HIV infection. It is recommended as one HIV prevention option for sexually active men who have sex with men and are at substantial risk of HIV acquisition. Additionally, it is recommended for heterosexually active men and women, and for adult injection drug users, who have substantial risk of HIV acquisition. Heterosexually active women and men whose partners have HIV infection (i.e., HIV-discordant couples) should be educated on the benefits and risks of PrEP during conception and pregnancy, as one of several options to protect the partner who is HIV-negative. There currently is not sufficient data on the efficacy and safety of PrEP for adolescents. Individuals who have acute or chronic HIV infection are not eligible for PrEP treatment. The following table provides a summary of the clinical indications and treatment recommendations for PrEP that are included in the clinical practice guidelines from the CDC.
Follow-up visits at least every 3 months to provide the following:
Studies conducted showed strong evidence supporting the use of PrEP.
Currently, Truvada is the only drug acknowledged as safe and effective by the FDA for prophylaxis. None of the PrEP studies found significant safety concerns with use of daily oral PrEP. Some participants in the trials did report mild side effects that usually resolved within a month. The safety of antiretroviral use to prevent HIV was confirmed in studies prior to the PrEP trials. The evidence from these human studies concluded that PrEP could reduce the risk of acquiring HIV infection from sexual and drug-use exposures, and the subsequent clinical trials were then launched and confirmed the safety and efficacy of PrEP in populations at risk of HIV infection.
PDR is a valuable resource for drug alerts and specific product labeling, such as for Truvada. Keep current by providing updated contact information and by using PDR.net for information on thousands of available products. If you use the electronic health record channel, please ask for it to include PDR drug data feeds, including PDR BRIEF. Updated drug information, full labeling, and safety warnings will be integrated into your electronic prescribing system automatically, and at no cost to you.
Salvatore Volpe, MD, FAAP, FACP, CHCQM Chief Medical Officer PDR