title: Brief Report: HIV-1 Evolution in Breakthrough Infections in a Human Trial of Oral Pre-exposure Prophylaxis With Emtricitabine and Tenofovir Disoproxil Fumarate.
abstract: We describe HIV-1 evolutionary dynamics in the 4 participants from the TDF2-PrEP trial who became HIV-1 infected while prescribed emtricitabine and tenofovir disoproxil fumarate (FTC/TDF). At seroconversion, virus diversity in the 2 participants with detectable drug was only 0.05% (95% confidence intervals: 0.04 to 0.06) and 0.07% (0.06 to 0.08) compared with 2.25% (1.95 to 2.6) and 0.42% (0.36 to 0.49) in those with no detectable drug and 0.07%-0.69% in 5 placebo recipients (P > 0.5). At 10 months, diversity in adherent participants was only 0.37% (0.31 to 0.41) and 0.86% (0.82 to 0.90) compared with 0.5%-1.7% among participants who did not take FTC/TDF (P > 0.5). Although limited by the small number of infections that reduced the power to detect differences, we found that sequences from seroconverters with detectable drug were more homogeneous than those from placebo or nonadherent seroconverters.
authors.affiliation: *Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV, Hepatitis, STD, and Prevention, Centers for Disease Control and Prevention, Atlanta, GA; and †Epidemiology Branch, Division of HIV/AIDS Prevention, National Center for HIV, Hepatitis, STD, and Prevention, Centers for Disease Control and Prevention, Atlanta, GA.
authors.forename: Susan
authors.initials: S
authors.lastname: Ruone
authors.forename: Lynn
authors.initials: L
authors.lastname: Paxton
authors.forename: Tony
authors.initials: T
authors.lastname: McLaurin
authors.forename: Allan
authors.initials: A
authors.lastname: Taylor
authors.forename: Debra
authors.initials: D
authors.lastname: Hanson
authors.forename: Walid
authors.initials: W
authors.lastname: Heneine
authors.forename: John T
authors.initials: JT
authors.lastname: Brooks
authors.forename: José Gerardo
authors.initials: JG
authors.lastname: García-Lerma
mesh_terms: D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001902:Botswana; D018791:CD4 Lymphocyte Count; D004311:Double-Blind Method; D000068679:Emtricitabine / Q000627:therapeutic use*; D019143:Evolution, Molecular; D015483:HIV Antibodies / Q000276:immunology; D015658:HIV Infections / Q000235:genetics / Q000276:immunology* / Q000517:prevention & control / Q000821:virology*; D015497:HIV-1 / Q000187:drug effects / Q000235:genetics / Q000276:immunology*; D006801:Humans; D065129:Pre-Exposure Prophylaxis; D000068698:Tenofovir / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents; D015483:HIV Antibodies; D000068698:Tenofovir; D000068679:Emtricitabine