Rotea-Salvo Sandra, Martínez-Pradeda Alejandro, Fernández-Oliveira Carla, Giménez-Arufe Victor, Balboa-Barreiro Vanesa, Margusino-Framiñán Luis, Mena-De-Cea Álvaro, Vázquez-Rodríguez Pilar, Castro-Iglesias Ángeles, López-Calvo Soledad, Martín-Herranz Isabel, Míguez-Rey Enrique, Cid-Silva Purificación
Service of Pharmacy, Universitary Hospital of A Coruña (CHUAC), SERGAS, A Coruña, Galicia, Spain.
Clinical Epidemiology and Biostatistics Unit, Biomedical Research Institute of A Coruña (INIBIC), Universitary Hospital of A Coruña (CHUAC), SERGAS. University of A Coruña (UDC), A Coruña, Galicia, Spain.
Eur J Hosp Pharm. 2023 Jul;30(4):221-226. doi: 10.1136/ejhpharm-2021-002896. Epub 2021 Oct 14.
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (EVG/c/FTC/TAF) and dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) are currently available for HIV patients.
This study evaluated modifications in the renal safety profile in a large real-world cohort of patients who had received EVG/c/FTC/TAF or DTG/ABC/3TC.
A retrospective observational study of HIV-infected patients who received EVG/c/FTC/TAF or DTG/ABC/3TC between March 2015 and June 2019 at a reference hospital in north-western Spain was conducted. Epidemiological, clinical, immunovirological data and information regarding antiretroviral therapy were recorded. The statistical differences between treatments were calculated.
A total of 457 patients were evaluated, 266 using EVG/c/FTC/TAF and 191 using DTG/ABC/3TC. Up to week 120, serum creatinine improved in both study groups among experienced patients (EVG/c/FTC/TAF 1.01±0.24 vs 0.91±0.19, p<0.001; DTG/ABC/3TC 1.08±0.24 vs 1.02±0.31, p<0.001), while in naïve patients serum creatinine remained stable compared with baseline. Statistically significant differences were found in serum creatinine when comparing both treatments at week 48 in experienced (0.94±0.21 vs 1.09±0.28, p<0.001) and naïve patients (0.89±0.16 vs 1.06±0.20, p=0.001), and among experienced patients at week 120 (0.91±0.19 vs 1.02±0.31, p=0.015) for the EVG/c/FTC/TAF and DTG/ABC/3TC groups, respectively. During the follow-up, 39 patients in EVG/c/FTC/TAF and 33 in DTG/ABC/3TC (p=0.449) discontinued treatment. The main reason for stopping treatment was adverse events, which were similar in both groups.
During the follow-up, patients experienced changes that were not clinically relevant in both treatment groups. Differences in renal events were not found.
艾维雷韦/考比司他/恩曲他滨/替诺福韦艾拉酚胺富马酸盐（EVG/c/FTC/TAF）和多替拉韦/阿巴卡韦/拉米夫定（DTG/ABC/3TC）目前可用于HIV患者。
本研究评估了在接受EVG/c/FTC/TAF或DTG/ABC/3TC治疗的大量真实世界患者队列中肾脏安全性概况的变化。
对2015年3月至2019年6月期间在西班牙西北部一家参考医院接受EVG/c/FTC/TAF或DTG/ABC/3TC治疗的HIV感染患者进行了一项回顾性观察研究。记录了流行病学、临床、免疫病毒学数据以及抗逆转录病毒治疗的相关信息。计算了治疗组之间的统计学差异。
共评估了457例患者，其中266例使用EVG/c/FTC/TAF，191例使用DTG/ABC/3TC。在120周时，经验丰富的患者中两个研究组的血清肌酐均有所改善（EVG/c/FTC/TAF组为1.01±0.24 vs 0.91±0.19，p<0.001；DTG/ABC/3TC组为1.08±0.24 vs 1.02±0.31，p<0.001），而初治患者的血清肌酐与基线相比保持稳定。在48周时，经验丰富的患者（0.94±0.21 vs 1.09±0.28，p<0.001）和初治患者（0.89±0.16 vs 1.06±0.20，p=0.001）中，比较两种治疗时血清肌酐存在统计学显著差异，在120周时经验丰富的患者中，EVG/c/FTC/TAF组和DTG/ABC/3TC组分别为（0.91±0.19 vs 1.02±0.31，p=0.015）。在随访期间，EVG/c/FTC/TAF组有39例患者和DTG/ABC/3TC组有33例患者（p=0.449）停止治疗。停止治疗的主要原因是不良事件，两组相似。
在随访期间，两个治疗组的患者经历了与临床无关的变化。未发现肾脏事件存在差异。
