Department of Infectious Diseases and Clinical Microbiology, Cerrahpasa School of Medicine, 532719Istanbul University-Cerrahpasa, Istanbul, Turkey.
Department of Infectious Diseases and Clinical Microbiology, Haseki Training and Research Hospital, University of Health Sciences, Istanbul, Turkey.
Int J STD AIDS. 2021 May;32(6):562-569. doi: 10.1177/0956462420983692. Epub 2021 Feb 18.
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) is a recommended and widely used regimen for HIV infection. In this study, we aimed to determine the efficacy and safety of E/C/F/TAF in people living with HIV (PLWH), who are either treatment-naïve or switched from any tenofovir disoproxil fumarate-containing regimen. For switched patients, we aimed to determine the impact of switching from tenofovir disoproxil fumarate (TDF) to TAF on lipid profile and kidney functions.
ACTHIV-IST Study Group produced a database, and five dedicated HIV centres in Istanbul entered data of PLWH who switched from any TDF-containing regimen to E/C/F/TAF and treatment-naïve patients who were initiated with the E/C/F/TAF regimen between January 2017 and December 2019. Clinical findings, viral parameters, lipid studies, renal function tests, adverse events and adherence to the treatment were recorded in this prospective observational study.
The study included a total of 614 switched and treatment-naïve patients. Of 430 treatment-experienced patients, 89% (382) were men, and the mean age was 42 ± 12 years. Among them, 47% (181/382) self-identified as men who have sex with men (MSM). The median duration of HIV diagnosis was 54 ± 29 months. The median duration of E/C/F/TAF use was 20 ± 36 months and that of previous treatment was 23 ± 18 months. HIV-RNA was undetectable at baseline and month 12 in 84.1% (360/428) and 86.1% (328/381) of patients, respectively ( > 0.05). Mean CD4 counts were 708 ± 287 cells/µL and 802 ± 305 cells/µL at baseline and month 12, respectively ( < 0.001). Serum creatinine levels remained stable during the treatment period. Mean total cholesterol levels at baseline and month 12 were 172 and 211 mg/dL ( < 0.01), LDL-cholesterol 104 and 138 mg/dL ( < 0.01), HDL-cholesterol 39 and 49 mg/dL ( < 0.01) and triglycerides 134 and 174 mg/dL ( < 0.01), respectively. The treatment was generally well tolerated. Eight patients discontinued the therapy (drug interaction: 3; lost to follow-up: 1; pregnancy: 1; pulmonary tuberculosis: 1; side effect: 1; patient's decision: 1). Of 184 treatment-naïve patients, 88% (162) were men, and the mean age was 36.5± 12 years. Among them, 50% (81/162) self-identified as MSM. The mean duration of HIV infection was 21.6 ± 17.1 months. The mean duration of E/C/F/TAF use was 16 ± 4 months. HIV-RNA was undetectable at baseline and month 12 in 1% and 89.1% of patients, respectively. Mean CD4 counts at baseline and month 12 were 469 ± 223 cells/µL and 740 ± 298 cells/µL, respectively. During the treatment period, creatinine levels remained stable. Total cholesterol, LDL-cholesterol, triglyceride and also HDL-cholesterol levels increased. Mean total cholesterol levels at baseline and month 12 were 167 and 211 mg/dL ( < 0.01), LDL-cholesterol 108 and 143 mg/dL ( < 0.01), HDL-cholesterol 41 and 47 mg/dL ( < 0.01) and triglycerides 136 and 172 mg/dL, respectively ( < 0.01). The treatment was generally well tolerated. Three patients discontinued the therapy (drug interaction: 1; non-responder: 1; patient's decision: 1).
Starting with or switching to E/C/F/TAF in PLWH effectively suppresses HIV infection, is associated with an increase in CD4 cell count and is well tolerated in a real-life setting. Renal functions remained stable during the treatment. E/C/F/TAF use was associated with an increase in LDL-cholesterol and triglyceride levels along with an increase in HDL-cholesterol levels.
依维莫司/考比司他/恩曲他滨/替诺福韦艾拉酚胺（E/C/F/TAF）是一种被推荐且广泛应用于 HIV 感染的治疗方案。本研究旨在评估 E/C/F/TAF 对初治和已接受替诺福韦酯（TDF）治疗的 HIV 感染者的疗效和安全性。对于转换治疗的患者，我们旨在评估从 TDF 转换为 TAF 对血脂谱和肾功能的影响。
ACTHIV-IST 研究小组建立了一个数据库，伊斯坦布尔的五个专门的 HIV 中心将在 2017 年 1 月至 2019 年 12 月期间，将任何含 TDF 的方案转换为 E/C/F/TAF 或开始使用 E/C/F/TAF 方案的初治和已接受治疗的 HIV 感染者的数据录入其中。在这项前瞻性观察性研究中，记录了临床发现、病毒参数、血脂研究、肾功能检查、不良事件和治疗依从性。
该研究共纳入 614 例转换治疗和初治患者。在 430 例有治疗经验的患者中，89%（382 例）为男性，平均年龄为 42±12 岁。其中，47%（181 例）自认为是男男性接触者（MSM）。HIV 诊断的中位时间为 54±29 个月。E/C/F/TAF 的中位使用时间为 20±36 个月，之前治疗的中位时间为 23±18 个月。84.1%（360/428）和 86.1%（328/381）的患者在基线和第 12 个月时 HIV-RNA 不可检测（>0.05）。平均 CD4 计数分别为基线时 708±287 个/µL 和第 12 个月时 802±305 个/µL（<0.001）。治疗期间血清肌酐水平保持稳定。基线和第 12 个月时总胆固醇平均水平分别为 172 和 211mg/dL（<0.01），低密度脂蛋白胆固醇分别为 104 和 138mg/dL（<0.01），高密度脂蛋白胆固醇分别为 39 和 49mg/dL（<0.01），三酰甘油分别为 134 和 174mg/dL（<0.01）。治疗总体上耐受性良好。8 例患者停止治疗（药物相互作用：3 例；失访：1 例；妊娠：1 例；肺结核：1 例；不良反应：1 例；患者决定：1 例）。在 184 例初治患者中，88%（162 例）为男性，平均年龄为 36.5±12 岁。其中，50%（81 例）自认为是 MSM。HIV 感染的中位时间为 21.6±17.1 个月。E/C/F/TAF 的中位使用时间为 16±4 个月。1%和 89.1%的患者在基线和第 12 个月时 HIV-RNA 不可检测。基线和第 12 个月时的平均 CD4 计数分别为 469±223 个/µL 和 740±298 个/µL。治疗期间，肌酐水平保持稳定。总胆固醇、低密度脂蛋白胆固醇、三酰甘油和高密度脂蛋白胆固醇水平升高。基线和第 12 个月时总胆固醇平均水平分别为 167 和 211mg/dL（<0.01），低密度脂蛋白胆固醇分别为 108 和 143mg/dL（<0.01），高密度脂蛋白胆固醇分别为 41 和 47mg/dL（<0.01），三酰甘油分别为 136 和 172mg/dL（<0.01）。治疗总体上耐受性良好。有 3 例患者停止治疗（药物相互作用：1 例；无应答：1 例；患者决定：1 例）。
在真实环境中，初治或转换为 E/C/F/TAF 治疗的 HIV 感染者能有效抑制 HIV 感染，CD4 细胞计数增加，且治疗耐受性良好。治疗期间肾功能保持稳定。E/C/F/TAF 的使用与 LDL 胆固醇和三酰甘油水平升高以及高密度脂蛋白胆固醇水平升高有关。
