CD4 cell counts ( <200) at the third month of HAART may predict clinical failure.
     Reprinted abstract from current issue of Jnl of AIDS

JOURNAL: AIDS
VOLUME: 13
ISSUE: 13
PAGES: 1669-1676

RECEIVED: 8 February 1999

ACCEPTED: 27 May 1999

AUTHOR: Antonella d'Arminio Monforte*, Valeria Testori*, Fulvio Adorni†, Barbara Castelnuovo*, Teresa Bini*, Letizia Testa*, GianCarla Moscatelli *, Elisabetta Chiesa*, Stefano Rusconi*, Clara Abeli*, Salvatore Sollima*, Massimo Musicco†, Luca Meroni*, Massimo Galli*, Mauro Moroni*

ADDRESS: *Institute of Infectious and Tropical Diseases, University of Milan, Milan, Italy; †National Research Council-Institute of Advanced Biomedical Technologies (CNR-ITBA), Milan, Italy

OBJECTIVE: To evaluate the influence of immunological and virological markers on clinical outcome in patients receiving their first highly active antiretroviral therapy (HAART) regimen.

DESIGN AND METHODS: Observational study of 585 patients initiating HAART in a clinical setting. Clinical failure was defined as the occurrence of new or recurrent AIDS-defining events or death, and was analysed by means of intention-to-treat, univariate and multivariate analyses. An adjusted Cox regression model was used to evaluate the effect of 3-month CD4 cell counts on clinical outcome.

RESULTS: Clinical failure occurred in 55 patients (9.4%) during a median follow-up of 483 days (range 33 – 1334 days): 45 new AIDS-defining events (ADEs) in 38, ADE recurrence in six, and death in 11. Twenty-four of the 45 new ADEs (53.4%) occurred during the first 3 months of HAART, and 11 of 45 (24.4%) in the presence of CD4 cell counts greater than 200 x 106cells/l. The mean (median, range) CD4 counts were 144 x 106 cells/l (128, 4 – 529) in patients with and 322 x 106cells/l (288, 14 – 1162) in patients without clinical failure (P< 0.0001). Moreover, the proportion of patients with mean CD4 cell counts <200 x 106cells/l was higher in those experiencing subsequent clinical failure (c2: 26.75; P <0.00001). Multivariate analysis showed that baseline CD4 cell counts <50 x 106cells/l and AIDS at enrolment predicted failure; after adjusting for 3-month CD4 cell counts, this marker was the only one independently associated with clinical failure (hazard risk, 4.79; 95% confidence interval, 1.40 – 16.47).

CONCLUSIONS: The 3-month immunological response is a reliable predictor of long-term clinical outcome.

AIDS 1999, 13: 1669-1676 © 1999 Lippincott Williams & Wilkins