Am J Epidemiol 2003; 157:738-746.
Copyright © 2003 by Johns
Hopkins Bloomberg School of Public Health
ORIGINAL CONTRIBUTIONS |
When to Initiate Highly Active Antiretroviral Therapy: A Cohort Approach
1 Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.
2 Northwestern University Medical School and Howard Brown Health Center, Chicago, IL.
3 School of Public Health, University of California Los Angeles, Los Angeles, CA.
4 Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.
5 Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA.
The appropriate immunologic stage of human immunodeficiency virus infection at which to initiate highly active antiretroviral therapy (HAART) among asymptomatic persons is a core question. A cohort approach using longitudinal data from the US Multicenter AIDS Cohort Study was used to mimic a clinical trial to assess the risk of acquired immunodeficiency syndrome (AIDS) by timing of therapy. Three treatment groups were defined according to CD4+ count (cells/µl) at HAART initiation between July 1995 and January 2000: <200 (deferral to <200, n = 127), 200–349 (deferral to 200–349, n = 130), and 350–499 (immediate treatment, n = 92). Survival analysis was used to compare time to AIDS between groups from the index visit until July 2000. The index visit for the immediate group was the one prior to HAART initiation. For the deferral groups, the index visit was a randomly selected, pre-HAART, AIDS-free visit after July 1990 at which CD4+ counts were 350–499 cells/µl. This strategy accounted for lead time bias. Compared with immediate treatment, the relative hazards of AIDS were 2.68 (p = 0.003) and 1.05 (p = 0.897) for deferral to <200 cells/µl and 200–349 cells/µl, respectively. These results support recent US public health guidelines for deferring HAART initiation until a count of <350 cells/µl. Furthermore, results suggest a potential threshold for HAART initiation in the neighborhood of 275 cells/µl.
cohort studies; epidemiologic methods; HIV
Abbreviations: Abbreviations: AIDS, acquired immunodeficiency syndrome; CI, confidence interval; D <200, deferred treatment group of men whose CD4+ counts were <200 cells/µl; D <350, deferred treatment group of men whose CD4+ counts were 200–349 cells/µl; HAART, highly active antiretroviral therapy; HIV, human immunodeficiency virus.
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