Yang Junyang, Wang Lin, Zhang Xiaoran, Liu Li, Shen Yinzhong, Qi Tangkai, Wang Zhenyan, Song Wei, Tang Yang, Xu Shuibao, Sun Jianjun, Chen Youming, Shen Yihong, Chen Jun, Zhang Renfang
Department of Infection and Immunology, Shanghai Public Health Clinical Center, Fudan University, Shanghai, PR China.
Department of Nursing, Shanghai Public Health Clinical Center, Fudan University, Shanghai, PR China.
J Med Microbiol. 2025 Jan;74(1). doi: 10.1099/jmm.0.001949.
Lamivudine plus dolutegravir (3TC/DTG) and bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) regimens are commonly used as first-line treatments for people living with human immunodeficiency virus (HIV) (PLWH) worldwide. There are limited comparative data on the antiviral activity and safety between these regimens in ART-naive PLWH, particularly in China, where the 3TC/DTG regimen was integrated into first-line therapy in 2021 and gained broader adoption after its inclusion in the National Health Insurance in 2022. This study aims to provide real-world evidence comparing the 3TC/DTG regimen to the B/F/TAF regimen in ART-naive PLWH in China. This retrospective study enrolled PLWH initiating ART with either 3TC/DTG or B/F/TAF in Shanghai from January 2020 to January 2023. Demographic characteristics and clinical information were collected and compared for each patient. A total of 380 eligible, ART-naive PLWH were included, with 190 patients in the 3TC/DTG group and 190 patients in the B/F/TAF group. Following the initiation of ART, most patients (94.1 and 89.3% for 3TC/DTG and B/F/TAF groups, respectively) achieved viral suppression (<50 copies of HIV RNA per millilitre) at week 24. The CD4 cell count significantly increased from a baseline of 301.3±185.8 cells per microlitre to 479.5±229.3 cells per microlitre at week 36 for the 3TC/DTG group and from 289.2±188.8 cells per microlitre at baseline to 487.8±234.2 cells per microlitre at week 36 for the B/F/TAF group. Both groups experienced an increase in blood lipid levels after initiating ART, with higher levels of high-density lipoprotein cholesterol (HDL-C) observed in the 3TC/DTG group compared with the B/F/TAF group. Renal and hepatic function indicators remained stable in both groups. 3TC/DTG demonstrates similar antiviral efficacy to B/F/TAF and does not significantly impact liver and kidney functions. Patients receiving 3TC/DTG showed higher plasma HDL-C levels compared with those on B/F/TAF, which confer long-term clinical benefits in reducing cardiovascular risk.
拉米夫定联合多替拉韦（3TC/DTG）方案和比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（B/F/TAF）方案是全球范围内常用于治疗人类免疫缺陷病毒（HIV）感染者（PLWH）的一线治疗方案。在初治的PLWH中，关于这些方案之间抗病毒活性和安全性的比较数据有限，在中国尤其如此，3TC/DTG方案于2021年被纳入一线治疗，并在2022年被纳入国家医疗保险后得到更广泛的应用。本研究旨在提供真实世界证据，比较中国初治PLWH中3TC/DTG方案和B/F/TAF方案。这项回顾性研究纳入了2020年1月至2023年1月在上海开始接受3TC/DTG或B/F/TAF抗逆转录病毒治疗（ART）的PLWH。收集并比较了每位患者的人口统计学特征和临床信息。共纳入380例符合条件的初治PLWH，3TC/DTG组190例，B/F/TAF组190例。开始ART后，大多数患者（3TC/DTG组和B/F/TAF组分别为94.1%和89.3%）在第24周实现了病毒抑制（每毫升HIV RNA<50拷贝）。3TC/DTG组在第36周时CD4细胞计数从基线时的每微升301.3±185.8个细胞显著增加到每微升479.5±229.3个细胞，B/F/TAF组从基线时的每微升289.2±188.8个细胞增加到第36周时的每微升487.8±234.2个细胞。两组在开始ART后血脂水平均有所升高，3TC/DTG组观察到的高密度脂蛋白胆固醇（HDL-C）水平高于B/F/TAF组。两组的肾功能和肝功能指标均保持稳定。3TC/DTG显示出与B/F/TAF相似的抗病毒疗效，且对肝脏和肾脏功能无显著影响。与接受B/F/TAF的患者相比，接受3TC/DTG的患者血浆HDL-C水平更高，这在降低心血管风险方面具有长期临床益处。
