American Journal of Epidemiology Vol. 155, No. 8 : 760-770
Copyright © 2002 by The Johns Hopkins University School of Hygiene and Public Health
ORIGINAL CONTRIBUTIONS |
Evaluation of the Effectiveness of Highly Active Antiretroviral Therapy in Persons with Human Immunodeficiency Virus using Biomarker-based Equivalence of Disease Progression
1 Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.
2 Comprehensive AIDS Center, Northwestern University Medical School, Chicago, IL.
3 Department of Microbiology and Molecular Immunology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD.
4 Department of Infectious Diseases and Microbiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA.
5 Department of Epidemiology, School of Public Health, University of California, Los Angeles, CA.
The association of different CD4+ cell counts with the same disease risk in treated and untreated populations reflects the effectiveness of highly active antiretroviral therapy (HAART) in persons with human immunodeficiency virus (HIV). Clinical progression of disease following initiation of HAART was determined for 679 HIV-infected men in the Multicenter AIDS Cohort Study by means of Kaplan-Meier survival analyses. Cox proportional hazards models were used to assess the effects of markers of HIV disease, antiretroviral history, and demographic factors. Men who had been followed since January 1993 (pre-HAART) were used to identify CD4+ levels associated with the acquired immunodeficiency syndrome (AIDS)-free time equivalent to that of men starting HAART with CD4+ cell counts of <200 cells/µl. Within 3.5 years following HAART initiation, 11.3% of the subjects developed AIDS and 8.5% died. Determinants of AIDS were a CD4+ cell count of <200 cells/µl at initiation (relative hazard = 2.25, 95% confidence interval: 1.13, 4.49) and age >45 years at initiation (relative hazard = 1.92, 95% confidence interval: 0.98, 3.77). An increase in CD4+ cell count of >50 cells/µl immediately after HAART initiation also improved prognosis (relative hazard = 0.34, 95% confidence interval: 0.16, 0.71). AIDS risk in men starting HAART with CD4+ counts of <200 cells/µl (median = 132) was similar to that of non-HAART users with CD4+ counts of 375–475 cells/µl (median = 432). The equivalence of disease progression to that of nonusers with approximately 300 more cells per µl demonstrates that HAART users have a broader reconstitution of the immune system beyond that of observed increases in CD4+ cell count.
acquired immunodeficiency syndrome; antiviral agents; clinical protocols; cohort studies; disease progression; HIV protease inhibitors; reverse transcriptase inhibitors; treatment outcome
Abbreviations: AIDS, acquired immunodeficiency syndrome; HAART, highly active antiretroviral therapy; HIV, human immunodeficiency virus
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