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Abstract
Risk of clinical progression over long term follow-up in a wide cohort of patients by different patterns of viro-immunological response assessed at month 18. results of the Italian MASTER cohort
C. Torti1, G. Paraninfo1, S. Casari1, E. Quiros Roldan1, F. Suter2, F. Maggiolo2, T. Quirino3, G. Migliorino3, L. Minoli4, R. Maserati4, F. Ghinelli5, L. Sighinolfi5, F. Mazzotta6, S. Lo Caputo6, A. Antinori7, F. Antonucci8, G. Pastore9, N. Ladisa9, F. Castelnuovo10, C. Tinelli11, A. De Silvestri11, G. Carosi1
1University of Brescia, Institute for Infectious and Tropical Diseases, Brescia, Italy, 2Ospedali Riuniti di Bergamo, Department of Infectious Diseases, Bergamo, Italy, 3Ospedale di Circolo, Department of Infectious Diseases, Busto Arsizio, Italy, 4University of Pavia, Institute of Infectious Diseases, Pavia, Italy, 5S. Anna Hospital, Department of Infectious Diseases, Ferrara, Italy, 6S.M. Annunziata Hospital, Department of Infectious Diseases, Florence, Italy, 7IRCCS `L. Spallanzani`, National Institute for Infectious Diseases, Rome, Italy, 8IRRCS `L. Spallanzani`, National Institute for Infectious Diseases, Rome, Italy, 9University of Bari, Institute of Infectious Diseases, Bari, Italy, 10Spedali Civili of Brescia, Department of Infectious Diseases, Brescia, Italy, 11IRCCS Policlinico S. Matteo, Department of Biostatistics, Pavia, Italy
Background: HAART increases survival of HIV +ve patients. However, improved knowledge of clinical predictors over long-term follow-up is required to optimize HIV-disease management.
Methods: All HIV-positive patients in the observational longitudinal MASTER cohort who started HAART between 1996-2002, with minimum follow-up available at month 18 after HAART have been studied. New AIDS-defining-events (ADE) and/or AIDS-related-deaths have been considered as outcome measure. Cross-check with Italian National AIDS Registry has been performed. Three univariate and multivariable Cox proportional hazards regression models were performed, respectively:
(i) baseline;
(ii) time-updated clinical variables, including initial viro-immunological effectiveness ranked into three groups (V+/I-, i.e.: HIV-RNA<400 c/ml for 1 year after six month HAART and lack of CD4+ increase by at least 25% from baseline; V+/I+ and; V-/I+) and;
(iii) both baseline & time-updated variables.
Results: Amongst 1,157 patients over a mean follow-up of 58 months (IQR: 39-77), 144 ADE’s and 11 AIDS-related-deaths were recorded. When baseline factors were tested, only clinical class C (CDC ’93, modified) was independently correlated with outcome (HR: 4.3; 95%C.I. 2.6-7.2; P<0.0001). In the time-updated model, the following variables appeared to protect from the risk of ADE/death: months on boosted-protease-inhibitor (PI)-based regimens (per month HR: 0.98; 95%C.I. 0.96-0.997; P=0.025) and higher last CD4+ T cell counts (>350 vs. <200/mm3 HR: 0.08; 95%C.I. 0.03-0.18; P<0.0001 and 200-350 vs. <200/mm3 HR: 0.21; 95%C.I. 0.086-0.52; P: 0.001). In the baseline & follow-up model, either baseline clinical stage and last available CD4+ resulted independent predictors.
Conclusions: Diagnosis of HIV infection, treatment before ADE and maintenance of high CD4+ T cell count induced by HAART remain important priorities protecting from AIDS morbidity and mortality over a long-term follow-up even in this cohort of patients who followed a first line HAART for at least 18 months. Viro-immunological trends over this initial period did not appear to influence subsequent clinical progression.
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