Moving HIV pre-exposure prophylaxis into clinical settings: lessons from buprenorphine.

Human immunodeficiency virus transmission frequently accompanies substance use. High-risk sexual behaviors done under the influence of alcohol, cocaine, methamphetamines and injection drug use contribute disproportionately to the ongoing spread of HIV.1–3 Effective HIV prevention efforts for these individuals and their partners include expanded combination antiretroviral therapy for those who are HIV-infected, condoms, behavioral interventions including substance abuse counseling, and for those who inject drugs, the implementation of needle and syringe exchange programs, and opioid-agonist treatment,4 including methadone and buprenorphine.5 Since its approval by the Food and Drug Administration in 2002, buprenorphine, an opioid-agonist medication used in the treatment of opioid-dependence, has been provided to over one million patients with an estimated 300,000 individuals (approximately 10% of those with opioid-dependence) currently receiving this treatment in a range of settings, including primary care, addiction treatment centers, and HIV clinics.6 Data from 2009 indicates that 60% of patients used third-party insurance to cover the cost of buprenorphine while 29% were self-pay and 11% used Medicaid coverage.7 Twenty thousand physicians from various specialties, including primary care physicians, psychiatrists, and addiction specialists, have received the training required to prescribe this treatment.8 Prior to the introduction of buprenorphine, physicians were prohibited from providing opioid-agonist medication to treat opioid-dependence, resulting in a general lack of knowledge, skills, and attitudes for most physicians. The introduction of buprenorphine, therefore, required a concerted effort among federal agencies and medical societies to address the training needs for this new practice in medicine. Although there is considerable practice variation in screening and treatment practices, federal guidelines recommend a comprehensive evaluation, focused physical exam and laboratories, along with treatment planning, which can take 30–45 minutes at the initial visit.9 The duration of treatment should be tailored to the clinical response and can range from days to years,10 and improved outcomes are associated with longer periods of treatment.11–13 The lessons learned may help inform the dissemination of pre-exposure prophylaxis (PrEP) in primary care practices where people without HIV infection typically seek health care.14 Pre-exposure prophylaxis, which is the use of antiretroviral medication by HIV-negative patients, represents a potential strategy for HIV prevention in those with substance use disorders and those in whom the use of substances and sexual behaviors puts them at increased risk for HIV transmission. PrEP involves the use of daily oral antiretroviral therapy14 initiated in advance of possible HIV exposure to decrease risk of HIV acquisition by uninfected individuals engaging in high-risk behaviors.15 Evidence from clinical trials16–18 and modeling studies19–21 provides optimism for the potential effectiveness of PrEP among particular populations, with results of an RCT being conducted with injection drug users expected in late 2012.22 The successful implementation of PrEP in those with substance use disorders to reduce their risk of sexual acquisition of HIV infection will require a multipronged approach, including; (1) provision of the medication; (2) safety screening; (3) behavioral interventions; (4) integration of PrEP as part of comprehensive care; and (5) monitoring PrEP’s population impact.23 The current article outlines potential challenges to the introduction of PreP based on the experience from implementing buprenorphine, including a recent effort funded by the Health Resources and Services Administration Special Programs of National Significance to expand buprenorphine into HIV clinics, and considers strategies to address those challenges.24