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

Jens Lundgren; 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; Strategies for Management of Antiretroviral Therapy (SMART) Study Group

doi:10.1086/586713

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

Jens Lundgren, 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, Strategies for Management of Antiretroviral Therapy (SMART) Study Group

327 Citations (Scopus)

Abstract

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 language	English
Journal	Journal of Infectious Diseases
Volume	197
Issue number	8
Pages (from-to)	1133-44
Number of pages	11
ISSN	0022-1899
DOIs	https://doi.org/10.1086/586713
Publication status	Published - 2008

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10.1086/586713

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Lundgren, J., 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., & Strategies for Management of Antiretroviral Therapy (SMART) Study Group (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), 1133-44. https://doi.org/10.1086/586713

Lundgren, J, Emery, S, Neuhaus, JA, Phillips, AN, Babiker, A, Cohen, CJ, Gatell, JM, Girard, P-M, Grund, B, Law, M, Losso, MH, Palfreeman, A, Wood, R & Strategies for Management of Antiretroviral Therapy (SMART) Study Group 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, vol. 197, no. 8, pp. 1133-44. https://doi.org/10.1086/586713

@article{012eaaf0ff3811ddb219000ea68e967b,

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

abstract = "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.",

author = "Jens Lundgren and Sean Emery and Neuhaus, {Jacqueline A} and Phillips, {Andrew N} and Abdel Babiker and Cohen, {Calvin J} and Gatell, {Jose M} and Pierre-Marie Girard and Birgit Grund and Matthew Law and Losso, {Marcelo H} and Adrian Palfreeman and Robin Wood and {Strategies for Management of Antiretroviral Therapy (SMART) Study Group}",

note = "Keywords: 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",

year = "2008",

doi = "10.1086/586713",

language = "English",

volume = "197",

pages = "1133--44",

journal = "Journal of Infectious Diseases",

issn = "0022-1899",

publisher = "Oxford University Press",

number = "8",

}

TY - JOUR

T1 - Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study

AU - Lundgren, Jens

AU - Emery, Sean

AU - Neuhaus, Jacqueline A

AU - Phillips, Andrew N

AU - Babiker, Abdel

AU - Cohen, Calvin J

AU - Gatell, Jose M

AU - Girard, Pierre-Marie

AU - Grund, Birgit

AU - Law, Matthew

AU - Losso, Marcelo H

AU - Palfreeman, Adrian

AU - Wood, Robin

AU - Strategies for Management of Antiretroviral Therapy (SMART) Study Group

N1 - Keywords: 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

PY - 2008

Y1 - 2008

N2 - 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.

AB - 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.

U2 - 10.1086/586713

DO - 10.1086/586713

M3 - Journal article

C2 - 18476292

SN - 0022-1899

VL - 197

SP - 1133

EP - 1144

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

IS - 8

ER -

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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