The Key Laboratory of Environmental Pollution Monitoring and Disease Control, Ministry of Education, School of Public Health, Guizhou Medical University, Guiyang, Guizhou, China.
Department of Infection, Guiyang Public Health Clinical Center, Guiyang, Guizhou, China.
Immun Inflamm Dis. 2023 Aug;11(8):e974. doi: 10.1002/iid3.974.
Prospective studies examining long-term therapeutic outcomes of the Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) regimen in human immunodeficiency virus (HIV) infection remain limited. This study assessed the actual efficacy and safety of BIC/FTC/TAF in HIV-infected individuals in southwest China.
This was a single-center, prospective study enrolling ART-naïve (n = 32) and ART-experienced (n = 177) HIV-infected patients administered BIC/FTC/TAF treatment between March 2022 and August 2022. The data were collected until February 28, 2023. Virological reactions and adverse events to the treatment were recorded, and patient subjective feelings in the form of Electronic Patient Reporting Outcome (ePRO) were collected. The primary endpoint was the rate of patients with HIV viral load <50 copies/mL at Week 24.
At Week 24, 87.5% and 95.5% of ART-naïve and ART-experienced HIV patients had a viral load <50 copies/mL, respectively. CD4 cell counts in ART-naïve and ART-experienced patients increased significantly by 163.5 cells/μL (p = .002) and 55.0 cells/μL (p = .022), respectively. By Week 24, no patients had discontinued the BIC/FTC/TAF treatment due to adverse events. Based on ePRO data, ART-naïve and ART-experienced patients at Week 24 had stable disease symptom burden, quality of life, and depression level after treatment with BIC/FTC/TAF.
BIC/FTC/TAF reduces the viral load in ART-naïve patients with high viral load as well as ART-experienced patients with residual viremia. The patient's subjective experience was maintained stable after treatment with BIC/FTC/TAF. This study also revealed a very low incidence for BIC/FTC/TAF drug-related side effects.
关于比克替拉韦/恩曲他滨/丙酚替诺福韦（BIC/FTC/TAF）方案在人类免疫缺陷病毒（HIV）感染中的长期治疗效果的前瞻性研究仍然有限。本研究评估了 BIC/FTC/TAF 在我国西南地区 HIV 感染者中的实际疗效和安全性。
这是一项单中心、前瞻性研究，纳入了 2022 年 3 月至 2022 年 8 月期间接受 BIC/FTC/TAF 治疗的初治（n=32）和经治（n=177）HIV 感染者。数据收集截至 2023 年 2 月 28 日。记录病毒学反应和治疗的不良反应，并以电子患者报告结局（ePRO）的形式收集患者的主观感受。主要终点是第 24 周时 HIV 病毒载量<50 拷贝/mL 的患者比例。
第 24 周时，初治和经治 HIV 患者的病毒载量<50 拷贝/mL 的比例分别为 87.5%和 95.5%。初治和经治患者的 CD4 细胞计数分别显著增加了 163.5 个/μL（p=0.002）和 55.0 个/μL（p=0.022）。截至第 24 周，没有患者因不良反应而停止 BIC/FTC/TAF 治疗。基于 ePRO 数据，第 24 周时初治和经治患者在接受 BIC/FTC/TAF 治疗后，疾病症状负担、生活质量和抑郁水平保持稳定。
BIC/FTC/TAF 可降低高病毒载量初治患者和残留病毒血症经治患者的病毒载量。BIC/FTC/TAF 治疗后，患者的主观体验保持稳定。本研究还显示 BIC/FTC/TAF 药物相关不良反应发生率非常低。
