Vergori Alessandra, Del Duca Giulia, Lorenzini Patrizia, Brita Anna Clelia, Mastrorosa Ilaria, Fusto Marisa, Camici Marta, Ottou Sandrine, Gagliardini Roberta, Paulicelli Jessica, De Zottis Federico, Grilli Elisabetta, Esvan Rozenn, Plazzi Maria Maddalena, Mazzotta Valentina, Bellagamba Rita, Antinori Andrea, Pinnetti Carmela
Immunodeficiency Unit, National Institute for Infectious Diseases "Lazzaro Spallanzani", IRCCS.
National Centre for Disease Prevention and Health Promotion, Italian National Institute of Health.
AIDS. 2025 Mar 1;39(3):270-275. doi: 10.1097/QAD.0000000000004043. Epub 2024 Oct 24.
The aim was to investigate whether switching from efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/F/TDF) to bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) may improve neuropsychiatric symptoms and neurocognition.
Pilot, single-arm, prospective study of persons with HIV (PWH) on the efficacy and safety of switching from EFV/F/TDF to BIC/F/TAF.
Participants underwent neuropsychological assessment (NPA) at switch (T0) and after 48 weeks (T1). NPA was carried out through a standardized battery of 12 tests. Neurocognitive impairment (NCI) was defined by a score of at least 1 standard deviation (SD) below the normal mean on at least two tests or ≥2 SD below on one test. Individual z scores were determined, NPZ-12 was calculated as the average of 12 test z scores and change of NPZ-12 was the outcome. HIV-associated neurocognitive disorder (HAND) was classified by Frascati's criteria. Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI-II), and Pittsburgh Sleep Quality Index (PSQI) were administered. Paired-Wilcoxon and McNemar tests were used for comparisons, and logistic regression for associations with NCI changes.
Out of 126 participants, BAI, BDI-II, and PSQI questionnaires revealed an improvement at T1. NPA revealed NCI in 40.5% of persons at T0 and 42.1% at T1 ( P = 0.746). Specifically, at T0, among participants with NCI, 35% improved; among those without, 26% worsened at T1; NPZ-12 score worsened at T1. 5.6% of ANI was observed at T0 and 7.9% at T1. No factor associated with these changes was found.
Our results suggest switching from EFV/F/TDF to B/F/TAF significantly improves psychiatric symptoms and sleep quality. Neurocognitive performance remained stable, although a decline in NPZ-12 and in specific domains was observed.
旨在研究从依非韦伦/恩曲他滨/替诺福韦酯（EFV/F/TDF）转换为比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（BIC/F/TAF）是否可改善神经精神症状和神经认知功能。
对感染人类免疫缺陷病毒（HIV）的患者（PWH）进行的先导性、单臂、前瞻性研究，以探讨从EFV/F/TDF转换为BIC/F/TAF的疗效和安全性。
参与者在转换时（T0）和48周后（T1）接受神经心理学评估（NPA）。NPA通过一套包含12项测试的标准化量表进行。神经认知障碍（NCI）定义为至少两项测试得分低于正常均值至少1个标准差（SD），或一项测试得分低于正常均值≥2个标准差。确定个体z分数，计算NPZ-12作为12项测试z分数的平均值，NPZ-12的变化为研究结果。根据弗拉斯卡蒂标准对HIV相关神经认知障碍（HAND）进行分类。使用贝克焦虑量表（BAI）、贝克抑郁量表（BDI-II）和匹兹堡睡眠质量指数（PSQI）进行评估。采用配对威尔科克森检验和麦克尼马尔检验进行比较，并使用逻辑回归分析与NCI变化的相关性。
126名参与者中，BAI、BDI-II和PSQI问卷显示在T1时有所改善。NPA显示，T0时40.5%的人存在NCI，T1时为42.1%（P = 0.746）。具体而言，在T0时，NCI参与者中35%有所改善；无NCI者中，26%在T1时病情恶化；NPZ-12得分在T1时恶化。T0时观察到5.6%的轻度神经认知障碍（ANI），T1时为7.9%。未发现与这些变化相关的因素。
我们的结果表明，从EFV/F/TDF转换为B/F/TAF可显著改善精神症状和睡眠质量。神经认知表现保持稳定，尽管观察到NPZ-12及特定领域有所下降。
