Editorial Commentary: Scaling Up Antiretroviral Preexposure Prophylaxis: Moving From Trials to Implementation

During the past decade there have been 10 efficacy trials evaluating the use of oral or topical tenofovir-based regimens to prevent human immunodeficiency virus (HIV) transmission in at-risk populations, including young African heterosexuals, men and transgender women who have sex with men, and Thai injecting drug users [1–10]. Seven of these 10 studies demonstrated the efficacy of antiretroviral preexposure prophylaxis (PrEP), and in 3 studies where HIV incidence did not differ between the intervention and control arms, the major reason for the lack of efficacy was medication nonadherence [7, 8, 11]. The weight of the evidence from these PrEP studies has led to US Food and Drug Administration approval for the use of oral tenofovir coformulated with emtricitabine for anti-HIV PrEP [12]. Demonstration projects are underway in several parts of the world, so it is likely that tenofoviremtricitabine for PrEP will soon be approved for use in several countries in Latin America, Africa, Asia, and Europe [13]. Of note, the 3 studies focusing on men who have sex with men (MSM) had highly successful results, including the PROUD (Pragmatic OpenLabel Randomised Trial of Preexposure Prophylaxis) study in the United Kingdom, in which MSM who attended genitourinary medicine clinics were randomized to receive PrEP immediately or be put on a waiting list and be offered PrEP after a year. The HIV incidence was so high in the waiting list group (7.8% annually), and PrEP so effective (86% decrease in HIV acquisition), that the study had to stop early, after accrual of about 10% of projected enrollment. These findings are particularly important, given that the rate of new HIV infections continue to increase dramatically among MSM domestically and globally. Despite the demonstrated efficacy of PrEP and the approval by regulatory bodies in the United States, uptake has not been rapid. In recent years, the concept of a continuum of HIV care has been a helpful heuristic for the assessment of the effectiveness of virological suppression at a population level [14]. In the current issue of Clinical Infectious Diseases, Kelley et al [15] have reviewed some of the sources of attenuation in the Atlanta HIV prevention continuum (ie, barriers to PrEP provision for high-risk MSM). Their data suggest that only about 15% of MSM who would be appropriate candidates for PrEP would probably access the medication. Part of the problem is that PrEP awareness remains low, albeit having increased somewhat over the past few years [16, 17]. Social disenfranchisement plays a role; that is, MSM who are poorer or less educated seem to be less informed about PrEP [18]. Medical mistrust remains entrenched for some African Americans because of historical adverse experiences with clinical research (eg, the Tuskegee experiment), leading to the tuning out of new information [19]. Media campaigns by some “PrEP denialists”may have created confusion for some who might benefit from PrEP [20]. In addition to lack of awareness and misinformation that may lead to reticence about using PrEP, another major barrier is posed by medication and health services costs (>$12 000 annually for those without insurance). The current study by Kelley et al [15] highlights this challenge in the current health reform environment. Because Atlanta is a “blue” city in a “red” state, Georgia government has not embraced the Affordable Care Act, leaving many who might benefit from PrEP to be either uninsured or underinsured. Because 20 US states have not expanded Medicaid, access to PrEP may Received 14 July 2015; accepted 19 July 2015; electronically published 13 August 2015. Correspondence: Kenneth H. Mayer, MD, The Fenway Institute–Fenway Health, 1340 Boylston St, Eighth Flr, Boston, MA 02215 (khmayer@gmail.com). Clinical Infectious Diseases 2015;61(10):1598–600 © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals. permissions@oup.com. DOI: 10.1093/cid/civ665