CD4 Count and the Risk for Death in Patients Infected with HIV Receiving Antiretroviral Therapy
- Robert Yarchoan, MD;
- David J. Venzon, PhD;
- James M. Pluda, MD;
- Jill Lietzau, BSN;
- Kathleen M. Wyvill, BSN;
- Anastasios A. Tsiatis, PhD;
- Seth M. Steinberg, PhD; and
- Samuel Broder, MD
Abstract
▪ Objective: To investigate the relation between CD4 count and the immediate hazard of dying in patients receiving zidovudine (azidothymidine [AZT])-based antiretroviral therapy.
▪ Setting: A research hospital that recruits patients from the entire United States.
▪ Design: Retrospective analysis of a cohort of patients with the acquired immunodeficiency syndrome (AIDS) or AIDS-related complex participating in longterm zidovudine-based antiretroviral protocols.
▪ Patients: Fifty-five patients with human immunodeficiency virus (HIV) infection and either AIDS or severe AIDS-related complex who were followed for as many as 4 years while they received antiretroviral therapy.
▪ Measurements: CD4 counts were measured.
▪ Main Results: Ten patients are known to be alive and 1 was lost to follow-up. Of the 44 patients who are known to have died, the CD4 range was known within 6 months of death in 41. All but 1 of these 41 assessable deaths occurred in patients whose CD4 counts were known to have fallen below 50 CD4 cells/mm3 (P < 10-10). The hazard of dying in the cohort ranged from 0 deaths/patient-month (95% Cl, 0 to 0.008 deaths/ patient-month) in patients with 200 or more CD4 cells/ mm3 to 0.07 deaths/patient-month (Cl, 0.050 to 0.094 deaths/patient-month) in patients with fewer than 50 CD4 cells/mm3. For the patients who died and whose cases were assessable, the mean of the last three CD4 counts obtained before death was 7.7 CD4 cells/mm3 (Cl, 0.9 to 63.3 cells/mm3). The median survival of patients once their CD4 counts fell below 50 CD4 cells/mm3 was 12.1 months (Cl, 7.2 to 19.4 months).
▪ Conclusions: In a carefully followed cohort treated with zidovudine-based antiretroviral therapy, nearly all deaths occurred in patients with fewer than 50 CD4 cells/mm3. These findings may have implications in the monitoring of patients with AIDS and in the use of CD4 count as a clinical trials end point for the antiretroviral therapy of HIV infection.
Article and Author Information
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From the National Cancer Institute, Bethesda, Maryland; and the Harvard School of Public Health, Boston, Massachusetts. For current author addresses, see end of text.
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Grant Support: In part by grant AI-24643 from the NIH and the National Institute of Allergy and Infectious Diseases.
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Requests for Reprints: Robert Yarchoan, MD, National Cancer Institute, Building 10, Room 13N248, National Institutes of Health, Bethesda, MD 20892.
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Current Author Addresses: Drs. Yarchoan, Venzon, Pluda, Steinberg, and Broder and Mrs. Lietzau and Mrs. Wyvill: National Cancer Institute, Building 10, National Institutes of Health, Bethesda, MD 20892.
Dr. Tsiatis: SDAC, Division of Biostatistics and Epidemiology, Dana Farber Cancer Institute, 44 Binney Street, Boston, MA 02115.
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