Guidance from the US Public Health Service and the World Health Organization is expected later this year. The Food and Drug Administration announced February 13th that it would review Gilead Science’s application to use FTC-TDF (brand name Truvada) for PrEP by June 15th. Demonstration projects to develop real world best practices for implementing PrEP are underway or set to launch soon in the United States and in sub-Saharan Africa. While the cost of PrEP in the U.S. would be substantial, private insurers and state Medicaid departments are open to providing coverage. Low-cost generic medications could enable access in low-income countries. The prioritization of highly vulnerable populations could increase the cost-effectiveness of PrEP. Providing PrEP is also much less expensive than treating someone for HIV over the course of a lifetime. Recent modeling of PrEP implementation coupled with scaled up treatment—focusing on MSM in San Francisco, the general adult population in Botswana, and serodiscordant couples in South Africa—predicts that PrEP could significantly reduce HIV incidence and prevalence.
In February 2012, The Fenway Institute released an analysis of PrEP implementation issues, titled Pre-exposure prophyalxis for HIV prevention: Moving toward implementation. This report summarizes the state of PrEP and microbicide research as of early 2012, looks at willingness to use PrEP among various populations, addresses concerns about PrEP that could present obstacles to implementation, offers strategies for effective implementation, and examines policy issues related to cost and how to make PrEP accessible to those most vulnerable to HIV. Based on a review of published research and interviews with policy makers, funders and other stakeholders, it examines regulatory developments and planning underway both within the U.S. and globally.