Torti
29/8/07
17:34
Page 941
Antiviral Therapy 12:941–947
Predictors of clinical progression among HIV-1positive patients starting HAART with CD4+ T-cell counts ≥200 cells/mm3 Giuseppe Lapadula1, Carlo Torti1*, Franco Maggiolo2, Salvatore Casari3, Fredy Suter 2, Lorenzo Minoli4, Chiara Pezzoli1, Massimo Di Pietro5, Guglielmo Migliorino6, Eugenia Quiros-Roldan1, Nicoletta Ladisa7, Laura Sighinolfi8, Silvia Costarelli1 and Giampiero Carosi1 for the Italian MASTER Cohort 1
Institute for Infectious and Tropical Diseases, University of Brescia, Italy Ospedali Riuniti di Bergamo, Bergamo, Italy 3 Spedali Civili di Brescia, Brescia, Italy 4 Institute of Clinical Infectious Diseases, IRCCS Policlinico S Matteo, Pavia, Italy 5 SM Annunziata Hospital, ASL Florence, Italy 6 Ospedale di Circolo, Busto Arsizio, Italy 7 Policlinico di Bari, Bari, Italy 8 S Anna Hospital, Ferrara, Italy 2
*Corresponding author: Tel: +39 030 3996624; Fax: +39 030 303061; E-mail:
[email protected]
Background: Baseline and follow-up predictors of new AIDS-defining events (ADE) or death among patients who started HAART with CD4+ T-cell counts ≥200 cells/mm3 have rarely been assessed simultaneously. Methods: A prospective observational cohort study (1996–2002) is reported. HIV-infected patients initiating HAART with a CD4+ T-cell count ≥200 cells/mm3 were studied. Baseline and time-varying factors were tested for the prediction of new ADE/death using Cox regression models. Results: A total of 896 subjects were studied over a median of 5.1 years. The incidence of a new ADE was 1.6 (95% confidence interval 1.3–2.1) per 100 personyears. Among baseline factors, higher CD4+ T-cell counts before HAART were associated with lower risk of ADE/death, but not after adjustment for time-varying factors. On a multivariable analysis including both
baseline and time-varying covariates, longer delay from HIV diagnosis to HAART was an independent predictor of ADE/death (per year, hazard ratio [HR] 1.06; P=0.025) and was independent of CD4+ T-cell count before treatment. Longer time spent with HIV RNA 300 cells/mm3 at the time of the diagnosis. AIDS dementia complex occurred mainly (7/8; 87.5%) when the CD4+ T-cell count was >200 cells/mm3 and in two cases when it was >500 cells/mm3.
Predictors of ADE/deaths Univariate analysis. Table 2 shows the results of a univariate analysis for both baseline and time-varying 943
Torti
29/8/07
17:34
Page 944
G Lapadula et al.
factors. Baseline factors that were associated with higher risk of ADE/deaths were IVDU as risk factor for HIV acquisition (P=0.022), HCV-Ab positivity (P=0.057) and delay from HIV diagnosis to antiretroviral therapy (P=0.003). CD4+ T-cell count before HAART initiation was inversely associated with the risk of ADE/death (P=0.001). The analysis of time-varying factors revealed the significant association of either higher CD4+ T-cell
counts or undetectable HIV RNA across the follow up with lower risk of ADE/death (P
