Douglas Krakower, MD; Kenneth H. Mayer, MD
Grant Support: This work was supported in part by the Harvard T32 postdoctoral HIV Clinical Research Fellowship grant NIAID AI 007433 to Dr. Krakower and the National Institutes of Health Center for AIDS Research grant P30AI42853 and National Institutes of Health Clinical Trial Unit for HIV Prevention and Microbicide Research grant U01AI069480 to Dr. Mayer. The funding sources had no role in the design, conduct, or analysis of this work or the decision to submit this manuscript for publication.
Potential Conflicts of Interest: Dr. Krakower: Grant (money to institution): Harvard T32 postdoctoral HIV Clinical Research Fellowship (grant NIAID AI 007433); Grants/grants pending (money to institution): Gilead Sciences, Bristol-Myers Squibb. Dr. Mayer: Grant (money to institution): National Institute of Health Center for AIDS Research (grant P30AI42853), National Institute of Health Clinical Trial Unit for HIV Prevention and Microbicide Research (grant U01AI069480); Grants/grants pending (money to institution): Gilead Sciences, Bristol-Myers Squibb, Merck. Disclosures can be also viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1390.
Requests for Single Reprints: Kenneth H. Mayer, MD, Fenway Health, 1340 Boylston Street, Boston, MA 02215; e-mail, email@example.com.
Current Author Addresses: Dr. Krakower: Division of Infectious Diseases, Beth Israel Deaconess Medical Center, 110 Francis Street, Lowry Medical Office Building, Suite GB, Boston, MA 02215.
Dr. Mayer: Fenway Health, 1340 Boylston Street, Boston, MA 02215.
Author Contributions: Conception and design: D. Krakower, K.H. Mayer.
Analysis and interpretation of the data: D. Krakower, K.H. Mayer.
Drafting of the article: D. Krakower, K.H. Mayer.
Critical revision of the article for important intellectual content: D. Krakower, K.H. Mayer.
Final approval of the article: D. Krakower, K.H. Mayer.
Obtaining of funding: D. Krakower, K.H. Mayer.
Collection and assembly of data: D. Krakower, K.H. Mayer.
As HIV prevalence climbs globally, including more than 50 000 new infections per year in the United States, we need more effective HIV prevention strategies. The use of antiretrovirals for preexposure prophylaxis (PrEP) among high-risk persons without HIV is emerging as one such strategy. Randomized, controlled trials have demonstrated that once-daily oral PrEP decreased HIV incidence among at-risk men who have sex with men and African heterosexuals, including serodiscordant couples. An additional randomized, controlled trial of a topical pericoital antiretroviral microbicide gel decreased HIV incidence among at-risk heterosexual South African women. Two other studies in African women did not demonstrate the efficacy of oral or topical PrEP, raising concerns about adherence patterns and efficacy in this population.
The U.S. Food and Drug Administration (FDA) Antiviral Drugs Advisory Committee reviewed these studies and additional data in May 2012 and voted to advise the approval of oral tenofovir–emtricitabine for PrEP in high-risk populations. On 16 July 2012, the FDA recommended that this combination medication be approved for use as PrEP in high-risk persons without HIV. Patients may seek PrEP from their primary care providers, and those receiving PrEP require monitoring. Thus, primary care providers should become familiar with PrEP. This review outlines current knowledge about PrEP as it pertains to primary care, including identifying persons likely to benefit from PrEP; counseling to maximize adherence and reduce potential increases in risky behavior; and monitoring for potential drug toxicities, HIV acquisition, and antiretroviral drug resistance. Issues related to cost and insurance coverage are also discussed. Recent data suggest that PrEP, combined with other prevention strategies, holds promise in helping to curtail the HIV epidemic.
Completed and Ongoing Efficacy Trials of HIV Antiretroviral PrEP
Baseline and Follow-up Assessment, Testing, and Counseling that Clinicians Should Provide When Prescribing HIV Antiretroviral PrEP
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Krakower D, Mayer KH. What Primary Care Providers Need to Know About Preexposure Prophylaxis for HIV Prevention: A Narrative Review. Ann Intern Med. ;157:490–497. doi: 10.7326/0003-4819-157-7-201210020-00510
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Published: Ann Intern Med. 2012;157(7):490-497.
HIV, Infectious Disease, Prevention/Screening.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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