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 Vjecha, Augusto Penalva de Oliveira, Barbara Standridge, Cate Carey, Anchalee Avihingsanon, Eric Florence, Jens D Lundgren, Alejandro Arenas-Pinto, Nicolas J Mueller, Alan Winston, Moses Supercharger Nsubuga, Luxi Lal, Richard W PriceINSIGHT START Neurology Substudy Group

    14 Citationer (Scopus)


    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.

    Udgave nummer8
    Sider (fra-til)985-997
    StatusUdgivet - maj 2018


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