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

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  • Sean Emery, Denmark
  • Jacqueline A Neuhaus, Denmark
  • Andrew N Phillips, Denmark
  • Abdel Babiker, Denmark
  • Calvin J Cohen, Denmark
  • Jose M Gatell, Denmark
  • Pierre-Marie Girard, Denmark
  • Birgit Grund, Denmark
  • Matthew Law, Denmark
  • Marcelo H Losso, Denmark
  • Adrian Palfreeman, Denmark
  • Robin Wood, Denmark
  • Lars Jørgen Østergaard
  • Strategies for Management of Antiretroviral Therapy (SMART) Study Group
  • The Department of Infectious Diseases
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.
Original languageEnglish
JournalJournal of Infectious Diseases
Volume197
Issue8
Pages (from-to)1133-44
Number of pages11
ISSN0022-1899
DOIs
Publication statusPublished - 2008

    Research areas

  • AIDS-Related Opportunistic Infections, Adult, Anti-HIV Agents, CD4 Lymphocyte Count, Cohort Studies, Drug Administration Schedule, Female, HIV, HIV Infections, Humans, Kaplan-Meiers Estimate, Male, Middle Aged, Treatment Outcome

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