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September 5, 2012

Ethical Challenges of Preexposure Prophylaxis for HIV

Author Affiliations

Author Affiliations: O’Neill Institute for National and Global Health Law, Georgetown University Law Center, Washington, DC.

JAMA. 2012;308(9):867-868. doi:10.1001/2012.jama.10158

On July 16, 2012, emtricitabine/tenofovir (Truvada; Gilead Sciences) became the first drug approved by the US Food and Drug Administration (FDA) for preexposure prophylaxis (PrEP) of human immunodeficiency virus (HIV) for adults at high risk. Clinical trials have demonstrated that daily use of oral antiretroviral drugs can reduce the risk of HIV acquisition through sexual intercourse. With 50 000 new HIV infections per year in the United States1 and 2 million per year worldwide,2 PrEP could become a major component of “combination prevention” along with condoms, counseling, testing, and treatment.

Emtricitabine/tenofovir is only partially effective for HIV prevention, with the Partners PrEP study of serodiscordant couples reporting a 75% risk reduction in HIV transmission.3 The effectiveness of PrEP correlates with adherence; the iPrEx study of male-to-male sexual contact reported more than 90% protection among study participants with high adherence,4 but 44% reduction in HIV transmission overall.5 Even a modest 44% reduction, however, would represent a clear benefit in high-prevalence settings and sexual networks. Researchers must closely monitor the results of ongoing open-label studies of PrEP, as well as use in practice, and if necessary, conduct pilot programs to increase adherence over time.

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