Major Clinical Outcomes in Antiretroviral Therapy (ART)–Naive Participants and in Those Not Receiving ART at Baseline in the SMART Study
BackgroundThe 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...
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| Published in: | The Journal of infectious diseases Vol. 197; no. 8; pp. 1133 - 1144 |
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| Main Authors: | , , , , , , , , , , , |
| Format: | Journal Article Web Resource |
| Language: | English |
| Published: |
United States
The University of Chicago Press
15-04-2008
University of Chicago Press |
| Subjects: | |
| Online Access: | Get full text |
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| Summary: | BackgroundThe 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 MethodsPatients 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) ResultsA 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) ConclusionsInitiation 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 registrationClinicalTrials.gov identifier: NCT00027352 |
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| Bibliography: | ark:/67375/HXZ-3DNL7T0B-G istex:80C92C6E113D323C67B203C187125E6B93284384 Study group members (including the members of the Writing Group, who authored this article), conflicts of interest, and the role of the funding source are listed after the text ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-News-2 ObjectType-Feature-3 scopus-id:2-s2.0-42549121220 |
| ISSN: | 0022-1899 1537-6613 1537-6613 |
| DOI: | 10.1086/586713 |