Article (Scientific journals)
Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study.
Emery, Sean; Neuhaus, Jacqueline A; Phillips, Andrew N et al.
2008In Journal of Infectious Diseases, 197 (8), p. 1133-44
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Keywords :
AIDS-Related Opportunistic Infections/immunology/mortality; Adult; Anti-HIV Agents/administration & dosage; CD4 Lymphocyte Count; Cohort Studies; Drug Administration Schedule; Female; HIV/immunology; HIV Infections/drug therapy/immunology/mortality/virology; Humans; Kaplan-Meiers Estimate; Male; Middle Aged; Treatment Outcome
Abstract :
[en] BACKGROUND: The SMART study randomized 5,472 human immunodeficiency virus (HIV)-infected patients with CD4+ cell counts >350 cells/microL to intermittent antiretroviral therapy (ART; the drug conservation [DC] group) versus continuous ART (the viral suppression [VS] group). In the DC group, participants started ART when the CD4+ cell count was <250 cells/microL. Clinical outcomes in participants not receiving ART at entry inform the early use of ART. METHODS: Patients who were either ART naive (n=249) or who had not been receiving ART for >or= 6 months (n=228) were analyzed. The following clinical outcomes were assessed: (i) opportunistic disease (OD) or death from any cause (OD/death); (ii) OD (fatal or nonfatal); (iii) serious non-AIDS events (cardiovascular, renal, and hepatic disease plus non-AIDS-defining cancers) and non-OD deaths; and (iv) the composite of outcomes (ii) and (iii). RESULTS: A total of 477 participants (228 in the DC group and 249 in the VS group) were followed (mean, 18 months). For outcome (iv), 21 and 6 events occurred in the DC (7 in ART-naive participants and 14 in those who had not received ART for >or= 6 months) and VS (2 in ART-naive participants and 4 in those who had not received ART for 6 months) groups, respectively. Hazard ratios for DC vs. VS by outcome category were as follows: outcome (i), 3.47 (95% confidence interval [CI], 1.26-9.56; p=.02); outcome (ii), 3.26 (95% CI, 1.04-10.25; p=.04); outcome (iii), 7.02 (95% CI, 1.57-31.38; p=.01); and outcome (iv), 4.19 (95% CI, 1.69-10.39; p=.002 ). CONCLUSIONS: Initiation of ART at CD4+ cell counts >350 cells/microL compared with <250 cells/microL may reduce both OD and serious non-AIDS events. These findings require validation in a large, randomized clinical trial.
Disciplines :
Immunology & infectious disease
Author, co-author :
Emery, Sean
Neuhaus, Jacqueline A
Phillips, Andrew N
Babiker, Abdel
Cohen, Calvin J
Gatell, Jose M
Girard, Pierre-Marie
Grund, Birgit
Law, Matthew
Losso, Marcelo H
Palfreeman, Adrian
Wood, Robin
Moutschen, Michel  ;  Université de Liège - ULiège > Département des sciences cliniques > Immunopathologie - Transplantation
More authors (3 more) Less
Language :
English
Title :
Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study.
Publication date :
2008
Journal title :
Journal of Infectious Diseases
ISSN :
0022-1899
eISSN :
1537-6613
Publisher :
University of Chicago Press, Chicago, United States - Illinois
Volume :
197
Issue :
8
Pages :
1133-44
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 04 September 2010

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