title: Sensitive tenofovir resistance screening of HIV-1 from the genital and blood compartments of women with breakthrough infections in the CAPRISA 004 tenofovir gel trial.
abstract: The Centre for the AIDS Programme of Research in South Africa 004 (CAPRISA 004) study demonstrated that vaginally applied tenofovir gel is a promising intervention for protecting women from sexually acquiring human immunodeficiency virus (HIV). However, the potential for emergence of tenofovir resistance remains a concern in women who seroconvert while using the gel despite the lack of plasma virus resistance as assessed by population sequencing during the trial. We applied highly sensitive polymerase chain reaction-based assays to screen for tenofovir resistance in plasma and vaginal swab specimens. The absence of mutation detection suggested little immediate risk of tenofovir-resistant HIV-1 emergence and forward transmission in settings in which gel users are closely monitored for HIV seroconversion.
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Xierong
authors.initials: X
authors.lastname: Wei
authors.affiliation: National Institute for Communicable Diseases.
authors.forename: Gillian
authors.initials: G
authors.lastname: Hunt
authors.affiliation: Department of Epidemiology, Columbia University, New York, New York CAPRISA-Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban.
authors.forename: Salim S
authors.initials: SS
authors.lastname: Abdool Karim
authors.affiliation: CAPRISA-Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban.
authors.forename: Vivek
authors.initials: V
authors.lastname: Naranbhai
authors.affiliation: CAPRISA-Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban.
authors.forename: Sengeziwe
authors.initials: S
authors.lastname: Sibeko
authors.affiliation: Department of Epidemiology, Columbia University, New York, New York CAPRISA-Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban.
authors.forename: Quarraisha
authors.initials: Q
authors.lastname: Abdool Karim
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Jin-Fen
authors.initials: JF
authors.lastname: Li
authors.affiliation: Eshelman School of Pharmacy, University of North Carolina, Chapel Hill.
authors.forename: Angela D M
authors.initials: AD
authors.lastname: Kashuba
authors.affiliation: CAPRISA-Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban.
authors.forename: Lise
authors.initials: L
authors.lastname: Werner
authors.affiliation: National Health Laboratory Service, Johannesburg CAPRISA-Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban.
authors.forename: Jo-Ann S
authors.initials: JA
authors.lastname: Passmore
authors.affiliation: National Institute for Communicable Diseases.
authors.forename: Lynn
authors.initials: L
authors.lastname: Morris
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Walid
authors.initials: W
authors.lastname: Heneine
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia.
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Johnson
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D024882:Drug Resistance, Viral; D005260:Female; D005782:Gels / Q000737:chemistry; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission; D015497:HIV-1 / Q000187:drug effects* / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D063065:Organophosphonates / Q000627:therapeutic use*; D016133:Polymerase Chain Reaction; D013019:South Africa; D000068698:Tenofovir; D014621:Vagina / Q000187:drug effects / Q000821:virology; D014622:Vaginal Creams, Foams, and Jellies / Q000494:pharmacology; D019562:Viral Load; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D005782:Gels; D063065:Organophosphonates; D014622:Vaginal Creams, Foams, and Jellies; D000068698:Tenofovir; D000225:Adenine
keywords: HIV prevention; Vaginal microbicide; pre-exposure prophylaxis; tenofovir gel; topical PrEP