Overcoming concerns and barriers to implementing pre-exposure prophylaxis for HIV prevention

Issues: Pre-exposure prophylaxis (PrEP) for HIV prevention has shown partial efficacy with men who have sex with men (MSM) and heterosexuals. Concerns include potential side effects, risk compensation, drug resistance, and cost. Guidance from the U.S. Public Health Service, U.S. Food and Drug Administration, and World Health Organization are expected in 2012. Demonstration projects are underway or soon to launch in several countries. Description: Expert consultation reports were reviewed, along with research on knowledge of/attitudes toward PrEP, implementation strategies, modeling of PrEP combined with expanded treatment, and cost-effectiveness. Key stakeholders and policymakers were interviewed. Lessons Learned: PrEP must be accompanied by sustained care and behavioral interventions to ensure adherence, minimize risk compensation, and monitor side effects. Because the most at-risk do not access regular clinical care, alternative implementation arrangements will be necessary. National monitoring systems are critical to preventing the spread of drug-resistant HIV. Clinical trials show no greater risk of side effects, no risk compensation, and no clinically significant development of drug resistance in participants. Modeling demonstrates the most effective deployment of PrEP will be in combination with scaled-up treatment. While cost of PrEP in the U.S. would be substantial, private insurers and state Medicaid departments are open to coverage, and low-cost generic medications could enable access in low-income countries. Recommendations: Implementation of PrEP should target highly vulnerable populations and be accompanied by sustained behavioral interventions and scaled-up treatment. Creative approaches (including intermittent PrEP and getting PrEP designated an Essential Health Benefit) could increase cost-effectiveness and access.