改用低神经毒性抗逆转录病毒药物改善 HIV-1 相关神经认知障碍患者的神经认知:MARAND-X 随机临床试验》。

IF 2.9 3区 医学 Q3 IMMUNOLOGY JAIDS Journal of Acquired Immune Deficiency Syndromes Pub Date : 2024-10-01 DOI:10.1097/qai.0000000000003480
Alessandro Lazzaro,Daniela Vai,Ambra Barco,Giacomo Stroffolini,Veronica Pirriatore,Giulia Guastamacchia,Marco Nigra,Valeria Ghisetti,Maria Cristina Tettoni,Giuseppe Noce,Claudia Giaccone,Mattia Trunfio,Alice Trentalange,Stefano Bonora,Giovanni Di Perri,Andrea Calcagno
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Participants had plasma and cerebrospinal fluid HIV RNA< 50 copies/mL, R5-tropic HIV, and were on ARV regimens that did not include efavirenz and darunavir. The change of resting-state electroencephalography was also evaluated. The outcomes were assessed at week 24 of the intervention through tests for longitudinal paired data and mixed-effect models.\r\n\r\nRESULTS\r\nThirty-eight participants were enrolled and 28 completed the follow-up. Global Deficit Score improved over time but with no difference between arms in longitudinal adjusted models. Perceptual functions improved in the MARAND-X, while long-term memory improved only in participants within the MARAND-X for whom the central nervous system penetration-effectiveness (CNS penetration effectiveness) score increased by ≥3. 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引用次数: 0

摘要

背景HIV相关神经认知(NC)损伤的发病机制是多因素的,抗逆转录病毒(ARV)的神经毒性可能是其中之一。方法单盲、随机(1:1)对照试验评估有神经认知障碍的 PLWH 的神经认知能力(全局缺陷评分、GDS 和领域评分)的变化,随机选择继续接受标准治疗或改用神经毒性较低的抗逆转录病毒疗法:达鲁那韦/可比司他、马拉韦罗、恩曲他滨(MARAND-X)。参与者的血浆和脑脊液中 HIV RNA< 50 copies/mL,HIV 为 R5-tropic,所使用的抗逆转录病毒疗法不包括依非韦伦和达鲁那韦。此外,还评估了静息状态脑电图的变化。通过纵向配对数据测试和混合效应模型,对干预第 24 周的结果进行了评估。随着时间的推移,总体缺陷评分有所改善,但在纵向调整模型中,不同干预组之间没有差异。MARAND-X治疗组的感知功能有所改善,而只有在中枢神经系统渗透效果(CNS penetration effectiveness)得分增加≥3的MARAND-X治疗组患者的长期记忆力才有所改善。结论 在这项规模较小但控制良好的研究中,使用神经毒性较低的抗逆转录病毒药物与保持不变的治疗方案相比并无重大益处。增加中枢神经系统穿透有效性评分对记忆领域的有益影响表明,抗逆转录病毒药物的神经穿透可能对认知功能有影响。
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Switching to Low Neurotoxic Antiretrovirals to Improve Neurocognition Among People Living With HIV-1-Associated Neurocognitive Disorder: The MARAND-X Randomized Clinical Trial.
BACKGROUND The pathogenesis of HIV-associated neurocognitive (NC) impairment is multifactorial, and antiretroviral (ARV) neurotoxicity may contribute. However, interventional pharmacological studies are limited. METHODS Single-blind, randomized (1:1), controlled trial to assess the change of NC performance (Global Deficit Score, GDS, and domain scores) in PLWH with NC impairment randomized to continue their standard of care treatment or to switch to a less neurotoxic ARV regimen: darunavir/cobicistat, maraviroc, emtricitabine (MARAND-X). Participants had plasma and cerebrospinal fluid HIV RNA< 50 copies/mL, R5-tropic HIV, and were on ARV regimens that did not include efavirenz and darunavir. The change of resting-state electroencephalography was also evaluated. The outcomes were assessed at week 24 of the intervention through tests for longitudinal paired data and mixed-effect models. RESULTS Thirty-eight participants were enrolled and 28 completed the follow-up. Global Deficit Score improved over time but with no difference between arms in longitudinal adjusted models. Perceptual functions improved in the MARAND-X, while long-term memory improved only in participants within the MARAND-X for whom the central nervous system penetration-effectiveness (CNS penetration effectiveness) score increased by ≥3. No significant changes in resting-state electroencephalography were observed. CONCLUSIONS In this small but well-controlled study, the use of less neurotoxic ARV showed no major beneficial effect over an unchanged regimen. The beneficial effects on the memory domain of increasing CNS penetration effectiveness score suggest that ARV neuropenetration may have a role in cognitive function.
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来源期刊
CiteScore
5.80
自引率
5.60%
发文量
490
审稿时长
3-6 weeks
期刊介绍: JAIDS: Journal of Acquired Immune Deficiency Syndromes​ seeks to end the HIV epidemic by presenting important new science across all disciplines that advance our understanding of the biology, treatment and prevention of HIV infection worldwide. JAIDS: Journal of Acquired Immune Deficiency Syndromes is the trusted, interdisciplinary resource for HIV- and AIDS-related information with a strong focus on basic and translational science, clinical science, and epidemiology and prevention. Co-edited by the foremost leaders in clinical virology, molecular biology, and epidemiology, JAIDS publishes vital information on the advances in diagnosis and treatment of HIV infections, as well as the latest research in the development of therapeutics and vaccine approaches. This ground-breaking journal brings together rigorously peer-reviewed articles, reviews of current research, results of clinical trials, and epidemiologic reports from around the world.
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