title: The cost-effectiveness of directly observed highly-active antiretroviral therapy in the third trimester in HIV-infected pregnant women.
abstract: BACKGROUND
  In HIV-infected pregnant women, viral suppression prevents mother-to-child HIV transmission. Directly observed highly-active antiretroviral therapy (HAART) enhances virological suppression, and could prevent transmission. Our objective was to project the effectiveness and cost-effectiveness of directly observed administration of antiretroviral drugs in pregnancy.
  
  
  RESULTS
  A mathematical model was created to simulate cohorts of one million asymptomatic HIV-infected pregnant women on HAART, with women randomly assigned self-administered or directly observed antiretroviral therapy (DOT), or no HAART, in a series of Monte Carlo simulations. Our primary outcome was the quality-adjusted life expectancy in years (QALY) of infants born to HIV-infected women, with the rates of Caesarean section and HIV-transmission after DOT use as intermediate outcomes. Both self-administered HAART and DOT were associated with decreased costs and increased life-expectancy relative to no HAART. The use of DOT was associated with a relative risk of HIV transmission of 0.39 relative to conventional HAART; was highly cost-effective in the cohort as a whole (cost-utility ratio $14,233 per QALY); and was cost-saving in women whose viral loads on self-administered HAART would have exceeded 1000 copies/ml. Results were stable in wide-ranging sensitivity analyses, with directly observed therapy cost-saving or highly cost-effective in almost all cases.
  
  
  CONCLUSIONS
  Based on the best available data, programs that optimize adherence to HAART through direct observation in pregnancy have the potential to diminish mother-to-child HIV transmission in a highly cost-effective manner. Targeted use of DOT in pregnant women with high viral loads, who could otherwise receive self-administered HAART would be a cost-saving intervention. These projections should be tested with randomized clinical trials.
authors.affiliation: Child Health Evaluative Sciences, Research Institute of the Hospital for Sick Children, Toronto, Ontario, Canada.
authors.forename: Caitlin J
authors.initials: CJ
authors.lastname: McCabe
authors.forename: Sue J
authors.initials: SJ
authors.lastname: Goldie
authors.forename: David N
authors.initials: DN
authors.lastname: Fisman
mesh_terms: D023241:Antiretroviral Therapy, Highly Active / Q000191:economics* / Q000379:methods; D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D023801:Directly Observed Therapy; D005260:Female; D015658:HIV Infections / Q000188:drug therapy*; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control; D008017:Life Expectancy; D008962:Models, Theoretical; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000188:drug therapy* / Q000191:economics; D011263:Pregnancy Trimester, Third; D016032:Randomized Controlled Trials as Topic; D019562:Viral Load
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