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
AU - Penalva de Oliveira, Augusto
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 Supercharger
AU - Lal, Luxi
AU - Price, Richard W
AU - INSIGHT START Neurology Substudy Group
PY - 2018/5
Y1 - 2018/5
N2 - OBJECTIVE: To compare the effect of immediate versus deferred antiretroviral treatment (ART) on neuropsychological test performance in treatment-naive HIV-positive adults with >500 CD4+ cells/μL.DESIGN: Randomized trial.METHODS: The START parent study randomized participants to commence immediate versus deferred ART until CD4+ <350 cells/μL. The START Neurology substudy used 8 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: 592 participants had a median age of 34 years; median baseline CD4+ count of 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).CONCLUSIONS: 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 >500 CD4+ cells/μL.DESIGN: Randomized trial.METHODS: The START parent study randomized participants to commence immediate versus deferred ART until CD4+ <350 cells/μL. The START Neurology substudy used 8 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: 592 participants had a median age of 34 years; median baseline CD4+ count of 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).CONCLUSIONS: 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.
KW - Journal Article
U2 - 10.1097/QAD.0000000000001778
DO - 10.1097/QAD.0000000000001778
M3 - Journal article
C2 - 29424786
VL - 32
SP - 985
EP - 997
JO - AIDS
JF - AIDS
SN - 0269-9370
IS - 8
ER -