Meeting reportPlanning for pre-exposure prophylaxis to prevent HIV transmission : challenges and opportunities

There are currently several ongoing or planned trials evaluating the efficacy of pre-exposure prophylaxis (PrEP) as a preventative approach to reducing the transmission of HIV. PrEP may prove ineffective, demonstrate partial efficacy, or show high efficacy and have the potential to reduce HIV infection in a significant way. However, in addition to the trial results, it is important that issues related to delivery, implementation and further research are also discussed. As a part of the ongoing discussion, in June 2009, the Bill & Melinda Gates Foundation sponsored a Planning for PrEP conference with stakeholders to review expected trial results, outline responsible educational approaches, and develop potential delivery and implementation strategies. The conference reinforced the need for continued and sustained dialogue to identify where PrEP implementation may fit best within an integrated HIV prevention package. This paper identifies the key action points that emerged from the Planning for PrEP meeting. Introduction Recent data suggest that current efforts to prevent and treat HIV are beginning to yield results. Significant expansion of antiretroviral therapy has led to decreased mortality. There has been some stabilization or decline in new HIV infections across several countries in sub-Saharan Africa, which is home to 67% of all people living with HIV [1]. Trend data indicate that there were 400,000 fewer new infections in that region in 2008 than there were in 2001 [2]. In South Africa specifically, there were 40% to 60% reductions in new HIV infections among youth over a five-year period ending in 2008 [3]. Despite these promising developments, much work remains. Overall HIV prevalence is unacceptably high and continues to rise in parts of the world. Approximately 33 million people were living with HIV and 2.7 million were newly infected in 2007 [1]. In eastern Europe and Asia, HIV disproportionately affects men who have sex with men (MSM), injecting drug users (IDUs) and sex workers [1]. Although behavioural interventions are important, and structural initiatives are needed to address the underlying determinants of vulnerability to HIV, technology can also provide needed additions to the prevention arsenal. Advances in the understanding of the pathogenesis of HIV have led to more sophisticated research on prevention strategies. Research has shown that early in infection, HIV targets and destroys the cells of the immune system that are likely best adapted to prevent establishment and control progression of disease [4]. It is therefore important to intervene before infection is established and pursue all avenues to develop a well-planned package of "combination prevention". This package should include effective and complementary modalities to decrease rates of HIV transmission to the greatest extent possible [5,6]. One technological prevention option currently under study that could be of great value is pre-exposure prophylaxis (PrEP). PrEP is a strategy for HIV-negative individuals to reduce or prevent their risk of infection by taking oral antiretroviral drugs used for HIV treatment or by applying microbicides containing the active antiretroviral agent. In June 2009, as part of the ongoing discussion surrounding PrEP, the Bill & Melinda Gates Foundation (BMGF) sponsored a Planning for PrEP conference, * Correspondence: sck3@law.georgetown.edu 1 O'Neill Institute for National and Global Health Law, Georgetown University,