Antiretroviral prophylaxis for HIV prevention in heterosexual men and women

  • Baeten J
  • Donnell D
  • Ndase P
 et al. 
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BACKGROUND: Antiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations. METHODS: We conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1-seronegative partner in each couple was randomly assigned to one of three study regimens - once-daily tenofovir (TDF), combination tenofovir-emtricitabine (TDF-FTC), or matching placebo - and followed monthly for up to 36 months. At enrollment, the HIV-1-seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services. RESULTS: We enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF-FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1-seronegative partner was male. Among HIV-1-seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF-FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P

Author-supplied keywords

  • CD4 lymphocyte count
  • Human immunodeficiency virus 1 infection
  • Kenya
  • NCT00557245
  • Uganda
  • adult
  • antiretrovirus agent
  • antiviral resistance
  • article
  • controlled study
  • creatinine
  • creatinine blood level
  • disease severity
  • double blind procedure
  • drug exposure
  • emtricitabine
  • fatigue
  • female
  • follow up
  • gastrointestinal toxicity
  • glucosuria
  • heterosexual female
  • heterosexual male
  • human
  • human cell
  • incidence
  • infection prevention
  • major clinical study
  • male
  • multicenter study
  • neutropenia
  • oral contraceptive agent
  • phase 3 clinical trial
  • phosphate blood level
  • phosphorus
  • placebo
  • practice guideline
  • preventive health service
  • priority journal
  • proteinuria
  • randomized controlled trial
  • seroconversion
  • side effect
  • tenofovir
  • treatment response

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  • J M Baeten

  • D Donnell

  • P Ndase

  • N R Mugo

  • J D Campbell

  • J Wangisi

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