Frange P, Veber F, Burgard M, Blanche S, Avettand-Fenoel V
Laboratoire de Microbiologie Clinique, Hôpital Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France.
EHU 7328 PACT, Institut Imagine, Université Paris Cité, Paris, France.
HIV Med. 2024 Feb;25(2):299-305. doi: 10.1111/hiv.13562. Epub 2023 Oct 8.
Although widely recommended, data on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) efficacy in HIV-1-infected children/adolescents are mainly extrapolated from studies in adults and one paediatric trial in which subjects have good treatment adherence. This study aimed to provide data about the risk of virological failure (VF) and acquired genotypic resistance in children and adolescents receiving BIC/FTC/TAF in a real-world setting.
This retrospective monocentric study included 74 paediatric patients who received BIC/FTC/TAF during ≥6 months in 2019-2023. VF was defined as not achieving a plasma viral load <50 copies/mL within 6 months of BIC/FTC/TAF initiation or as experiencing virological rebound ≥50 copies/mL.
Most patients were antiretroviral therapy (ART)-experienced (93.2%), previously exposed to integrase inhibitors (85.1%) and displayed viral suppression at baseline (67.6%). Their median age was 11.2 years [interquartile range (IQR): 8.8-15.2]. BIC/FTC/TAF introduction reduced treatment burden in most ART-experienced subjects. Genotypic susceptibility score of BIC/FTC/TAF was ≥2 in all cases. Median follow-up was 40 months (IQR: 21-46). VF occurred in 28 people (37.8%), more frequently in the case of VF versus viral suppression at baseline (68% vs. 26%, P = 0.02). BIC/FTC/TAF was interrupted for suspected intolerance in only one case (1.4%). Nucleoside reverse transcriptase inhibitor (NRTI) mutation (T69D/N) emerged in one patient (3.6% of VF) after 47 months of continuous detectable viraemia while on ART. No acquisition of mutations in the integrase gene was observed.
Because of its high genetic barrier to resistance, BIC/FTC/TAF could be especially useful in the paediatric population, in which the risk of poor treatment adherence and VF is high.
尽管比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（BIC/FTC/TAF）已被广泛推荐，但关于其在HIV-1感染儿童/青少年中的疗效数据主要是从成人研究及一项受试者治疗依从性良好的儿科试验中推断而来。本研究旨在提供在真实环境中接受BIC/FTC/TAF治疗的儿童和青少年发生病毒学失败（VF）及获得性基因型耐药风险的数据。
这项回顾性单中心研究纳入了2019年至2023年期间接受BIC/FTC/TAF治疗≥6个月的74名儿科患者。VF的定义为在开始使用BIC/FTC/TAF后6个月内未实现血浆病毒载量<50拷贝/mL，或病毒学反弹≥50拷贝/mL。
大多数患者有抗逆转录病毒治疗（ART）史（93.2%），既往接触过整合酶抑制剂（85.1%），且基线时病毒得到抑制（67.6%）。他们的中位年龄为11.2岁[四分位间距（IQR）：8.8 - 15.2]。引入BIC/FTC/TAF减轻了大多数有ART史受试者的治疗负担。所有病例中BIC/FTC/TAF的基因型敏感性评分均≥2。中位随访时间为40个月（IQR：21 - 46）。28人（37.8%）发生VF，VF患者较基线病毒抑制患者更常见（68%对26%，P = 0.02）。仅1例（1.4%）因疑似不耐受中断BIC/FTC/TAF治疗。1例患者（占VF患者的3.6%）在接受ART治疗期间持续可检测到病毒血症47个月后出现核苷类逆转录酶抑制剂（NRTI）突变（T69D/N）。未观察到整合酶基因突变。
由于其对耐药具有较高的遗传屏障，BIC/FTC/TAF在治疗依从性差和VF风险较高的儿科人群中可能特别有用。
