title: It's Time: The Case for PrEP as an Active Comparator in HIV Biomedical Prevention Trials.
abstract: In July 2012, based on evidence from two major trials, the United States Food and Drug Administration approved the use of combined oral tenofovir/emtricitabine as pre-exposure prophylaxis (PrEP) for people at high risk of HIV acquisition. PrEP effectiveness is marred by poor adherence, however, even in trial populations, thus it is not a magic bullet for HIV prevention. It is, however, the most effective biomedical HIV prevention intervention available for people at high risk of HIV, particularly those who have receptive sex and lack the power to negotiate condom use. Accordingly, there are compelling reasons to compare future experimental HIV prevention interventions against PrEP. The interests both of trial participants and of science are served by using PrEP as comparator: Not only would HIV incidence be reduced, but also the question of whether new interventions were superior to best proven interventions, in a given setting, would be answered comprehensively.
authors.affiliation: School of Public Health and Community Medicine, UNSW Australia, Sydney, NSW, 2052, Australia, bridget.haire@sydney.edu.au.
authors.forename: Bridget
authors.initials: B
authors.lastname: Haire
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D035843:Biomedical Research; D057186:Comparative Effectiveness Research; D017280:Condoms; D000068679:Emtricitabine / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D065129:Pre-Exposure Prophylaxis; D012107:Research Design; D012306:Risk; D012725:Sexual Behavior; D000068698:Tenofovir / Q000627:therapeutic use*
chemical_list: D019380:Anti-HIV Agents; D000068698:Tenofovir; D000068679:Emtricitabine