Switching from tenofovir disoproxil fumarate to bictegravir/emtricitabine/ tenofovir alafenamide or non-tenofovir alafenamide regimens: a real-world study of safety and efficacy in Chinese people living with HIV.

IF 4.6 2区医学 Q1 INFECTIOUS DISEASES

Expert Review of Anti-infective Therapy Pub Date : 2026-08-18 DOI:10.1080/14787210.2026.2718183

Fada Wang, Liyuan Zheng, Xiaojing Song, Leidan Zhang, Ling Chen, Yanling Li, Yang Han, Wei Yu, Wei Cao, Taisheng Li

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引用次数: 0

Abstract

Background: Tenofovir disoproxil fumarate (TDF) carries bone and renal toxicity risks. Data are limited on Chinese people living with HIV (PLWH) switching from TDF-based regimens to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) and non-BIC/FTC/TAF.

Research design and methods: This retrospective cohort study enrolled virologically-suppressed PLWH receiving TDF (>48 weeks) at PUMCH (2014-2025). We analyzed efficacy/safety at 96 weeks post-switch to BIC/FTC/TAF or non-BIC/FTC/TAF. Primary endpoints: viral suppression, immune recovery, and safety [bone mineral density(BMD)/eGFR/weight/serum lipids], assessed from 48 weeks pre-switch to 96 weeks post-switch.

Results: After screening, 169 of 1,592 PLWH were enrolled (mean age 41 years; 89.3% male; mean TDF duration 67.8 month): 111 switched to BIC/FTC/TAF, 58 to non-BIC/FTC/TAF (25 dolutegravir-based). All BIC/FTC/TAF recipients maintained virologic suppression but one low-level viremia in non-BIC/FTC/TAF, CD4⁺ T-cell increased similarly (p > 0.05). Pre-switch (48-week on TDF) BMD decreased (spine/hip/femoral neck: -1.78%/-3.03%/-2.39%); At week 96 post-switch, BMD increased (BIC/FTC/TAF: +3.55%/+2.52%/+3.48%; non-BIC/FTC/TAF: +2.18%/+2.19%/+2.8%; p > 0.05). Pre-switch eGFR similarly decreased: -9 mL/min/1.73 m², post-switch increased (BIC/FTC/TAF +3.6 vs non-BIC/FTC/TAF +5.1, p > 0.05). Pre-switch slight weight gain (+0.27 kg), post-switch: BIC/FTC/TAF (+1.59 kg), dolutegravir (DTG)-based (+3.54 kg), non-DTG/BIC (+0.95 kg). Serum lipids increased in all groups (p > 0.05).

Conclusions: Switching from TDF to BIC/FTC/TAF or Non-BIC/FTC/TAF was associated with improved bone/renal safety with maintained efficacy in Chinese PLWH. But integrase strand transfer inhibitor(INSTI)-based regimens necessitate monitoring for weight and lipid changes. These findings warrant confirmation in larger studies.

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从富马酸替诺福韦二氧吡酯到比替替韦/恩曲他滨/替诺福韦阿拉那胺或非替诺福韦阿拉那胺方案的转换：中国HIV感染者的安全性和有效性的真实世界研究。

背景：富马酸替诺福韦二氧吡酯（TDF）具有骨和肾毒性风险。关于中国HIV感染者（PLWH）从基于tdf的方案转向比替替韦/恩曲他滨/替诺福韦阿拉那胺（BIC/FTC/TAF）和非BIC/FTC/TAF的数据有限。研究设计和方法：本回顾性队列研究纳入了在PUMCH（2014-2025）接受TDF治疗的病毒学抑制的PLWH （bb0 - 48周）。我们分析了BIC/FTC/TAF或非BIC/FTC/TAF治疗后96周的疗效/安全性。主要终点：从转换前48周到转换后96周评估病毒抑制、免疫恢复和安全性[骨密度(BMD)/eGFR/体重/血脂]。结果：筛查后，1592名PLWH患者中有169人入组（平均年龄41岁，89.3%为男性，平均TDF持续时间67.8个月）：111人转为BIC/FTC/TAF， 58人转为非BIC/FTC/TAF（25人为孕妇）。所有BIC/FTC/TAF受体均维持病毒学抑制，但非BIC/FTC/TAF患者CD4+ t细胞水平明显升高（p < 0.05）。转换前（TDF治疗48周）骨密度降低（脊柱/髋关节/股骨颈：-1.78%/-3.03%/-2.39%）；周96 post-switch增加BMD (BIC / FTC / TAF: / / + 2.52% + 3.48% + 3.55%; non-BIC / FTC / TAF: / / + 2.19% + 2.8% + 2.18%; p > 0.05)。开关前eGFR同样下降：-9 mL/min/1.73 m2，开关后增加（BIC/FTC/TAF +3.6 vs非BIC/FTC/TAF +5.1, p > 0.05）。切换前体重轻微增加（+0.27 kg），切换后：BIC/FTC/TAF (+1.59 kg)，多替格拉韦（DTG）为基础（+3.54 kg），非DTG/BIC （+0.95 kg）。各组血清血脂均升高（p < 0.05）。结论：从TDF切换到BIC/FTC/TAF或非BIC/FTC/TAF可改善中国PLWH患者的骨/肾脏安全性并保持疗效。但整合酶链转移抑制剂（INSTI）为基础的方案需要监测体重和血脂的变化。这些发现值得在更大规模的研究中得到证实。

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来源期刊

Expert Review of Anti-infective Therapy 医学-药学

CiteScore

11.20

自引率

0.00%

发文量

审稿时长

4-8 weeks

期刊介绍： Expert Review of Anti-Infective Therapy (ISSN 1478-7210) provides expert reviews on therapeutics and diagnostics in the treatment of infectious disease. Coverage includes antibiotics, drug resistance, drug therapy, infectious disease medicine, antibacterial, antimicrobial, antifungal and antiviral approaches, and diagnostic tests.