Safety and Feasibility of Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With Men Aged 15 to 17 Years in the United States

Abstract

In July 2012, the US Food and Drug Administration approved the use of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) based on 3 studies that demonstrated efficacy for preventing HIV.^1-3 Since then, several open-label clinical trials and demonstration projects have supported the effectiveness of administering daily oral PrEP to prevent HIV.^4-7 None of these clinical trials included adolescent participants younger than 18 years, precluding regulatory agencies from considering the approval of TDF/FTC use for minors. Thus, a critical gap in approved prevention products exists for adolescents, a population that is highly vulnerable to HIV worldwide.