HIV感染者接受双药方案治疗后换用比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺的安全性和有效性：来自伊科纳队列的见解
Safety and effectiveness of switch to bictegravir/emtricitabine/tenofovir alafenamide following dual regimen therapy in people with HIV: Insights from the Icona cohort.
作者信息
De Vito Andrea, Tavelli Alessandro, Cozzi-Lepri Alessandro, Giacomelli Andrea, Rossotti Roberto, Ponta Giacomo, Bobbio Nicoletta, Ianniello Alice, Cingolani Antonella, Madeddu Giordano, Antinori Andrea, d'Arminio Monforte Antonella
机构信息
Unit of Infectious Disease, Department of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy.
PhD School in Biomedical Science, Biomedical Science Department, University of Sassari, Sassari, Italy.
出版信息
HIV Med. 2025 Jun;26(6):970-977. doi: 10.1111/hiv.70037. Epub 2025 Apr 28.
OBJECTIVES
Most treatment switches are for simplification from three-drug (3DR) to dual regimens (2DR). However, a proportion of people with HIV may switch back to 3DR, like bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) after 2DR.
METHODS
We included people with HIV enroled in the Icona cohort who switched to B/F/TAF after 2DR INSTI-based (3TC/DTG, RPV/DTG, RPV/CAB, or DOR + DTG). Virological rebound (VR), virological suppression (VS), and treatment discontinuation (TD) due to toxicity or failure were evaluated using Kaplan-Meier curves. Random intercept and slopes before and after the switch were used to evaluate the trajectories of triglycerides, cholesterol, CD4, and CD4/CD8. Viro-immunological analyses were stratified according to HIV-RNA at switch.
RESULTS
Among the 3662 people with HIV who started a 2DR INSTI-based regimen, 71 (1.9%) switched to B/F/TAF; 60 had been followed up after the switch, for a median of 10.9 months (interquartile range: 3.6-24.7). Forty people with HIV switched with HIV-RNA <50 copies/mL (uVL), 20 with HIV-RNA ≥50 copies/mL (dVL). Among the uVL group, one participant experienced VR (HIV-RNA: 99, 71 followed by 29 copies/mL). Among the dVL group, the 1-year cumulative probability of undetectable VL was 75% (95% confidence interval [CI] 57.6-95.1). Fourteen people with HIV interrupted B/F/TAF for simplification (50.0%), toxicity (28.6%), VR (14.2%), and patient's choice (7.1); the 1-year cumulative probability of TD for toxicity/failure was 10.7% (95% CI 14.5-24.5). We observed an increase in the CD4/CD8 ratio (+0.02 CD4/CD8/month, p = 0.026) only in the dVL group.
CONCLUSIONS
Switching from 2DR-INSTI to B/F/TAF is infrequent; this switch results in a low rate of toxicity and failure, along with a favourable immunovirological and lipid profile. CD4/CD8 gain is observed in those switching with detectable HIV-RNA.
目的
大多数治疗方案转换是为了从三联疗法（3DR）简化为双联疗法（2DR）。然而，一部分艾滋病毒感染者可能会在接受2DR治疗后又换回3DR，比如换成比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（B/F/TAF）。
方法
我们纳入了伊科纳队列中接受基于整合酶链转移抑制剂（INSTI）的2DR治疗后换成B/F/TAF的艾滋病毒感染者（3TC/DTG、RPV/DTG、RPV/CAB或DOR + DTG）。使用Kaplan-Meier曲线评估病毒学反弹（VR）、病毒学抑制（VS）以及因毒性或治疗失败导致的治疗中断（TD）情况。转换前后的随机截距和斜率用于评估甘油三酯、胆固醇、CD4和CD4/CD8的变化轨迹。病毒免疫学分析根据转换时的HIV-RNA水平进行分层。
结果
在3662名开始接受基于INSTI的2DR治疗方案的艾滋病毒感染者中，71人（1.9%）换成了B/F/TAF；转换后有60人接受了随访，中位随访时间为10.9个月（四分位间距：3.6 - 24.7个月）。40名艾滋病毒感染者在HIV-RNA <50拷贝/mL（病毒载量不可测，uVL）时进行了转换，20名在HIV-RNA≥50拷贝/mL（病毒载量可测，dVL）时进行了转换。在uVL组中，有1名参与者出现病毒学反弹（HIV-RNA：99，随后为71，然后是29拷贝/mL）。在dVL组中，病毒载量不可测的1年累积概率为75%（95%置信区间[CI] 57.6 - 95.1）。14名艾滋病毒感染者因简化治疗（50.0%）、毒性反应（28.6%）、病毒学反弹（14.2%）和患者自主选择（7.1%）中断了B/F/TAF治疗；因毒性/治疗失败导致治疗中断的1年累积概率为10.7%（95% CI 14.5 - 24.5）。我们仅在dVL组中观察到CD4/CD8比值有所增加（每月增加0.02 CD4/CD8，p = 0.026）。
结论
从基于INSTI的2DR转换为B/F/TAF的情况并不常见；这种转换导致毒性和治疗失败率较低，同时具有良好的免疫病毒学和血脂特征。在病毒载量可测的情况下进行转换的患者中观察到了CD4/CD8比值的增加。
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