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Robert S. Hogg, PhD; Benita Yip, BSc(Pharm); Keith J. Chan, MSc; Evan Wood, BSc; Kevin J. P. Craib, MMath; Michael V. O'Shaughnessy, OBC,PhD; Julio S. G. Montaner, MD,FRCPC,FCCP

JAMA. 2001;286:2568-2577.

Context  Current recommendations for initiation of antiretroviral therapy in patients infected with human immunodeficiency virus type 1 (HIV) are based on CD4 T-lymphocyte cell counts and plasma HIV RNA levels. The relative prognostic value of each marker following initiation of therapy has not been fully characterized.

Objective  To describe rates of disease progression to death and AIDS or death among patients starting triple-drug antiretroviral therapy, stratified by baseline CD4 cell count and HIV RNA levels.

Design, Setting, and Participants  Population-based analysis of 1219 antiretroviral therapy–naive HIV-positive men and women aged 18 years or older in British Columbia who initiated triple-drug therapy between August 1, 1996, and September 30, 1999.

Main Outcome Measure  Cumulative mortality rates from the initiation of triple-drug antiretroviral therapy to September 30, 2000, determined using various CD4 cell and plasma HIV RNA thresholds.

Results  As of September 30, 2000, 82 patients had died of AIDS-related causes, for a crude AIDS-related mortality rate of 6.7%. The product limit estimate (SE) of the cumulative mortality rate at 12 months was 2.9% (0.5%). In univariate analyses, a prior diagnosis of acquired immunodeficiency syndrome (AIDS), CD4 cell count, use of protease inhibitors, and HIV RNA level were associated with mortality. There was no difference in mortality by age or sex. Only CD4 cell count remained statistically significant in the multivariate analysis. After controlling for AIDS, protease inhibitor use, and plasma HIV RNA level at baseline, patients with CD4 cell counts of less than 50/µL were 6.67 (95% confidence interval [CI], 3.61-12.34) times and those with counts of 50/µL to 199/µL were 3.41 (95% CI, 1.93-6.03) times more likely to die than those with counts of at least 200/µL.

Conclusion  Our data demonstrate uniformly low rates of disease progression to death and AIDS or death among patients starting antiretroviral therapy with CD4 cell counts of at least 200/µL. In our study, disease progression to death and AIDS or death was clustered among patients starting therapy with CD4 cell counts less than 200/µL.

Author Affiliations: BC Centre for Excellence in HIV/AIDS (Drs Hogg, O'Shaughnessy, and Montaner, Ms Yip, and Messrs Chan, Wood, and Craib); Departments of Pathology and Laboratory Medicine (Dr O'Shaughnessy), Medicine (Dr Montaner), and Health Care and Epidemiology (Dr Hogg), Faculty of Medicine, University of British Columbia, Vancouver, British Columbia. Mr Wood is a doctoral candidate in the Department of Health Care and Epidemiology.

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