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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
[+] Article and Author Information

Grant Support: In part by grant AI-24643 from the NIH and the National Institute of Allergy and Infectious Diseases.

Requests for Reprints: Robert Yarchoan, MD, National Cancer Institute, Building 10, Room 13N248, National Institutes of Health, Bethesda, MD 20892.

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.


Ann Intern Med. 1991;115(3):184-189. doi:10.7326/0003-4819-115-3-184
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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.

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