Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART Study

Sean Emery, Jacqueline A. Neuhaus, Andrew N. Phillips, Abdel Babiker, Calvin J. Cohen, Jose M. Gatell, Pierre Marie Girard, Birgit Grund, Matthew Law, Marcelo H. Losso, Adrian Palfreeman, Robin Wood

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322 Scopus citations

Abstract

Background. The SMART study randomized 5472 human immunodeficiency virus (HIV)-infected patients with CD4+ cell counts >350 cells/μL to intermittent antiretroviral therapy (ART; the drug conservation [DC] group) versus continuous ART (the viral supression [VS] group). In the DC group, participants started ART when the CD4+ cell count was <250 cells/μL. 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 ≤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 ≤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/μL compared with <250 cells/μL may reduce both OD and serious non-AIDS events. These findings require validation in a large, randomized clinical trial. Trial registration. ClinicalTrials.gov identifier: NCT00027352.

Original languageEnglish (US)
Pages (from-to)1133-1144
Number of pages12
JournalJournal of Infectious Diseases
Volume197
Issue number8
DOIs
StatePublished - Apr 15 2008

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    Emery, S., Neuhaus, J. A., Phillips, A. N., Babiker, A., Cohen, C. J., Gatell, J. M., Girard, P. M., Grund, B., Law, M., Losso, M. H., Palfreeman, A., & Wood, R. (2008). Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART Study. Journal of Infectious Diseases, 197(8), 1133-1144. https://doi.org/10.1086/586713