Infectious Disease Clinic, IRCCS Policlinico San Martino Hospital, 16132 Genoa, Italy.
Unit of Infectious Diseases, "Divisione A", Amedeo di Savoia Hospital, 10149 Torino, Italy.
Viruses. 2022 May 11;14(5):1028. doi: 10.3390/v14051028.
The purpose of this study is to evaluate the frequency of central nervous system adverse events (CNS-AE) on dolutegravir (DTG) and non-DTG containing ART, and their reversibility, in the observational prospective SCOLTA cohort. Factors associated with CNS-AE were estimated using a Cox proportional-hazards model. 4939 people living with HIV (PLWH) were enrolled in DTG (n = 1179) and non-DTG (n = 3760) cohorts. Sixty-six SNC-AE leading to ART discontinuation were reported, 39/1179 (3.3%) in DTG and 27/3760 (0.7%) in non-DTG cohort. PLWH naïve to ART, with higher CD4 + T count and with psychiatric disorders were more likely to develop a CNS-AE. The risk was lower in non-DTG than DTG-cohort (aHR 0.33, 95% CI 0.19−0.55, p < 0.0001). One-year follow-up was available for 63/66 PLWH with CNS-AE. AE resolution was reported in 35/39 and 23/24 cases in DTG and non-DTG cohorts, respectively. The probability of AE reversibility was not different based on ART class, sex, ethnicity, CDC stage, or baseline psychiatric disorder. At the same time, a lower rate of event resolution was found in PLWH older than 50 years (p = 0.017). In conclusion, CNS-AE leading to ART discontinuation was more frequent in DTG than non-DTG treated PLWH. Most CNS-AE resolved after ART switch, similarly in both DTG and non-DTG cohorts.
本研究旨在评估含多替拉韦（DTG）和不含 DTG 的 ART 方案中，中枢神经系统不良事件（CNS-AE）的发生频率及其可逆性。采用 Cox 比例风险模型评估与 CNS-AE 相关的因素。共有 4939 名 HIV 感染者（PLWH）入组 DTG（n=1179）和非 DTG（n=3760）队列。共报告了 66 例导致 ART 停药的 SNC-AE，DTG 组 39/1179（3.3%），非 DTG 组 27/3760（0.7%）。ART 初治、CD4 + T 计数较高和患有精神障碍的 PLWH 更易发生 CNS-AE。与 DTG 组相比，非 DTG 组的风险较低（aHR 0.33，95%CI 0.19-0.55，p<0.0001）。66 例 CNS-AE 患者中有 63 例可进行 1 年随访。在 DTG 和非 DTG 组中，分别有 35/39 和 23/24 例 CNS-AE 得到缓解。ART 种类、性别、种族、CDC 分期或基线精神障碍与 CNS-AE 逆转概率无差异。同时，发现年龄大于 50 岁的 PLWH 中 CNS-AE 缓解率较低（p=0.017）。综上，DTG 治疗的 PLWH 中 CNS-AE 较非 DTG 治疗的更常见。大多数 CNS-AE 在 ART 转换后得到缓解，在 DTG 和非 DTG 组中相似。
