No neurocognitive advantage for immediate antiretroviral treatment in adults with greater than 500 CD4+ T-cell counts

Edwina J Wright; Birgit Grund; Kevin R Robertson; Lucette Cysique; Bruce J Brew; Gary L Collins; Mollie Poehlman-Roediger; Michael J Vjecha; Augusto César Penalva de Oliveira; Barbara Standridge; Cate Carey; Anchalee Avihingsanon; Eric Florence; Jens D Lundgren; Alejandro Arenas-Pinto; Nicolas J Mueller; Alan Winston; Moses S Nsubuga; Luxshimi Lal; Richard W Price; INSIGHT START Neurology Substudy Group

doi:10.1097/QAD.0000000000001778

No neurocognitive advantage for immediate antiretroviral treatment in adults with greater than 500 CD4+ T-cell counts

Edwina J Wright, Birgit Grund, Kevin R Robertson, Lucette Cysique, Bruce J Brew, Gary L Collins, Mollie Poehlman-Roediger, Michael J Vjecha, Augusto César Penalva de Oliveira, Barbara Standridge, Cate Carey, Anchalee Avihingsanon, Eric Florence, Jens D Lundgren, Alejandro Arenas-Pinto, Nicolas J Mueller, Alan Winston, Moses S Nsubuga, Luxshimi Lal, Richard W PriceINSIGHT START Neurology Substudy Group

Department of Clinical Medicine

4 Citations (Scopus)

Abstract

Objective: To compare the effect of immediate versus deferred antiretroviral treatment (ART) on neuropsychological test performance in treatment-naive HIV-positive adults with more than 500 CD4 + cells/μl. Design: Randomized trial. Methods: The START parent study randomized participants to commence immediate versus deferred ART until CD4 + less than 350 cells/μl. The START Neurology substudy used eight neuropsychological tests, at baseline, months 4, 8, 12 and annually, to compare groups for changes in test performance. Test results were internally standardized to z-scores. The primary outcome was the average of the eight test z-scores (QNPZ-8). Mean changes in QNPZ-8 from baseline were compared by intent-to-treat using longitudinal mixed models. Changes from baseline to specific time points were compared using ANCOVA models. Results: The 592 participants had a median age of 34 years; median baseline CD4 + count was 629 cells/μl; the mean follow-up was 3.4 years. ART was used for 94 and 32% of accrued person-years in the immediate and deferred groups, respectively. There was no difference between the immediate and deferred ART groups in QNPZ-8 change through follow-up [-0.018 (95% CI -0.062 to 0.027, P = 0.44)], or at any visit. However, QNPZ-8 scores increased in both arms during the first year, by 0.22 and 0.24, respectively (P < 0.001 for increase from baseline). Conclusion: We observed substantial improvement in neurocognitive test performance during the first year in both study arms, underlining the importance of using a control group in studies assessing neurocognitive performance over time. Immediate ART neither benefitted nor harmed neurocognitive performance in individuals with CD4 + cell counts above 500 cells/μl.

Original language	English
Journal	AIDS (London, England)
Volume	32
Issue number	8
Pages (from-to)	985-997
Number of pages	13
ISSN	0269-9370
DOIs	https://doi.org/10.1097/QAD.0000000000001778
Publication status	Published - 15 May 2018

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Wright, E. J., Grund, B., Robertson, K. R., Cysique, L., Brew, B. J., Collins, G. L., Poehlman-Roediger, M., Vjecha, M. J., Penalva de Oliveira, A. C., Standridge, B., Carey, C., Avihingsanon, A., Florence, E., Lundgren, J. D., Arenas-Pinto, A., Mueller, N. J., Winston, A., Nsubuga, M. S., Lal, L., ... INSIGHT START Neurology Substudy Group (2018). No neurocognitive advantage for immediate antiretroviral treatment in adults with greater than 500 CD4+ T-cell counts. AIDS (London, England), 32(8), 985-997. https://doi.org/10.1097/QAD.0000000000001778

Wright, EJ, Grund, B, Robertson, KR, Cysique, L, Brew, BJ, Collins, GL, Poehlman-Roediger, M, Vjecha, MJ, Penalva de Oliveira, AC, Standridge, B, Carey, C, Avihingsanon, A, Florence, E, Lundgren, JD, Arenas-Pinto, A, Mueller, NJ, Winston, A, Nsubuga, MS, Lal, L, Price, RW & INSIGHT START Neurology Substudy Group 2018, 'No neurocognitive advantage for immediate antiretroviral treatment in adults with greater than 500 CD4+ T-cell counts', AIDS (London, England), vol. 32, no. 8, pp. 985-997. https://doi.org/10.1097/QAD.0000000000001778

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title = "No neurocognitive advantage for immediate antiretroviral treatment in adults with greater than 500 CD4+ T-cell counts",

abstract = "Objective: To compare the effect of immediate versus deferred antiretroviral treatment (ART) on neuropsychological test performance in treatment-naive HIV-positive adults with more than 500 CD4 + cells/μl. Design: Randomized trial. Methods: The START parent study randomized participants to commence immediate versus deferred ART until CD4 + less than 350 cells/μl. The START Neurology substudy used eight neuropsychological tests, at baseline, months 4, 8, 12 and annually, to compare groups for changes in test performance. Test results were internally standardized to z-scores. The primary outcome was the average of the eight test z-scores (QNPZ-8). Mean changes in QNPZ-8 from baseline were compared by intent-to-treat using longitudinal mixed models. Changes from baseline to specific time points were compared using ANCOVA models. Results: The 592 participants had a median age of 34 years; median baseline CD4 + count was 629 cells/μl; the mean follow-up was 3.4 years. ART was used for 94 and 32% of accrued person-years in the immediate and deferred groups, respectively. There was no difference between the immediate and deferred ART groups in QNPZ-8 change through follow-up [-0.018 (95% CI -0.062 to 0.027, P = 0.44)], or at any visit. However, QNPZ-8 scores increased in both arms during the first year, by 0.22 and 0.24, respectively (P < 0.001 for increase from baseline). Conclusion: We observed substantial improvement in neurocognitive test performance during the first year in both study arms, underlining the importance of using a control group in studies assessing neurocognitive performance over time. Immediate ART neither benefitted nor harmed neurocognitive performance in individuals with CD4 + cell counts above 500 cells/μl.",

author = "Wright, {Edwina J} and Birgit Grund and Robertson, {Kevin R} and Lucette Cysique and Brew, {Bruce J} and Collins, {Gary L} and Mollie Poehlman-Roediger and Vjecha, {Michael J} and {Penalva de Oliveira}, {Augusto C{\'e}sar} and Barbara Standridge and Cate Carey and Anchalee Avihingsanon and Eric Florence and Lundgren, {Jens D} and Alejandro Arenas-Pinto and Mueller, {Nicolas J} and Alan Winston and Nsubuga, {Moses S} and Luxshimi Lal and Price, {Richard W} and {INSIGHT START Neurology Substudy Group}",

year = "2018",

month = may,

day = "15",

doi = "10.1097/QAD.0000000000001778",

language = "English",

volume = "32",

pages = "985--997",

journal = "AIDS (London, England)",

issn = "0269-9370",

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TY - JOUR

T1 - No neurocognitive advantage for immediate antiretroviral treatment in adults with greater than 500 CD4+ T-cell counts

AU - Wright, Edwina J

AU - Grund, Birgit

AU - Robertson, Kevin R

AU - Cysique, Lucette

AU - Brew, Bruce J

AU - Collins, Gary L

AU - Poehlman-Roediger, Mollie

AU - Vjecha, Michael J

AU - Penalva de Oliveira, Augusto César

AU - Standridge, Barbara

AU - Carey, Cate

AU - Avihingsanon, Anchalee

AU - Florence, Eric

AU - Lundgren, Jens D

AU - Arenas-Pinto, Alejandro

AU - Mueller, Nicolas J

AU - Winston, Alan

AU - Nsubuga, Moses S

AU - Lal, Luxshimi

AU - Price, Richard W

AU - INSIGHT START Neurology Substudy Group

PY - 2018/5/15

Y1 - 2018/5/15

N2 - Objective: To compare the effect of immediate versus deferred antiretroviral treatment (ART) on neuropsychological test performance in treatment-naive HIV-positive adults with more than 500 CD4 + cells/μl. Design: Randomized trial. Methods: The START parent study randomized participants to commence immediate versus deferred ART until CD4 + less than 350 cells/μl. The START Neurology substudy used eight neuropsychological tests, at baseline, months 4, 8, 12 and annually, to compare groups for changes in test performance. Test results were internally standardized to z-scores. The primary outcome was the average of the eight test z-scores (QNPZ-8). Mean changes in QNPZ-8 from baseline were compared by intent-to-treat using longitudinal mixed models. Changes from baseline to specific time points were compared using ANCOVA models. Results: The 592 participants had a median age of 34 years; median baseline CD4 + count was 629 cells/μl; the mean follow-up was 3.4 years. ART was used for 94 and 32% of accrued person-years in the immediate and deferred groups, respectively. There was no difference between the immediate and deferred ART groups in QNPZ-8 change through follow-up [-0.018 (95% CI -0.062 to 0.027, P = 0.44)], or at any visit. However, QNPZ-8 scores increased in both arms during the first year, by 0.22 and 0.24, respectively (P < 0.001 for increase from baseline). Conclusion: We observed substantial improvement in neurocognitive test performance during the first year in both study arms, underlining the importance of using a control group in studies assessing neurocognitive performance over time. Immediate ART neither benefitted nor harmed neurocognitive performance in individuals with CD4 + cell counts above 500 cells/μl.

AB - Objective: To compare the effect of immediate versus deferred antiretroviral treatment (ART) on neuropsychological test performance in treatment-naive HIV-positive adults with more than 500 CD4 + cells/μl. Design: Randomized trial. Methods: The START parent study randomized participants to commence immediate versus deferred ART until CD4 + less than 350 cells/μl. The START Neurology substudy used eight neuropsychological tests, at baseline, months 4, 8, 12 and annually, to compare groups for changes in test performance. Test results were internally standardized to z-scores. The primary outcome was the average of the eight test z-scores (QNPZ-8). Mean changes in QNPZ-8 from baseline were compared by intent-to-treat using longitudinal mixed models. Changes from baseline to specific time points were compared using ANCOVA models. Results: The 592 participants had a median age of 34 years; median baseline CD4 + count was 629 cells/μl; the mean follow-up was 3.4 years. ART was used for 94 and 32% of accrued person-years in the immediate and deferred groups, respectively. There was no difference between the immediate and deferred ART groups in QNPZ-8 change through follow-up [-0.018 (95% CI -0.062 to 0.027, P = 0.44)], or at any visit. However, QNPZ-8 scores increased in both arms during the first year, by 0.22 and 0.24, respectively (P < 0.001 for increase from baseline). Conclusion: We observed substantial improvement in neurocognitive test performance during the first year in both study arms, underlining the importance of using a control group in studies assessing neurocognitive performance over time. Immediate ART neither benefitted nor harmed neurocognitive performance in individuals with CD4 + cell counts above 500 cells/μl.

UR - https://journals.lww.com/aidsonline/Fulltext/2018/05150/No_neurocognitive_advantage_for_immediate.4.aspx

U2 - 10.1097/QAD.0000000000001778

DO - 10.1097/QAD.0000000000001778

M3 - Journal article

C2 - 29424786

SN - 0269-9370

VL - 32

SP - 985

EP - 997

JO - AIDS (London, England)

JF - AIDS (London, England)

IS - 8

ER -

No neurocognitive advantage for immediate antiretroviral treatment in adults with greater than 500 CD4+ T-cell counts

Abstract

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