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使用比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺治疗的一名两岁人类免疫缺陷病毒感染儿童实现了病毒的成功抑制。

Successful viral suppression in a two-year-old child with human immunodeficiency virus infection treated with bictegravir/emtricitabine/tenofovir alafenamide.

作者信息

Ekemen Coskun, Arslan Asli, Ozer Emine Cigdem, Erensoy Selda, Sahbudak Bal Zumrut, Avcu Gulhadiye

机构信息

Division of Pediatric Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Ege University, İzmir, Türkiye.

Department of Medical Microbiology, Faculty of Medicine, Ege University, İzmir, Türkiye.

出版信息

Turk J Pediatr. 2025 Jul 6;67(3):433-439. doi: 10.24953/turkjpediatr.2025.5998.

Abstract

BACKGROUND

Adherence to antiretroviral therapy (ART) is a major challenge in pediatric human immunodeficiency virus (HIV) management, especially in young children due to medication formulation, administration difficulties, and psychosocial barriers. Single-tablet regimens (STRs) have been shown to improve adherence and viral suppression in adults and adolescents, yet their use in younger children remains limited. Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is an STR with a high genetic barrier to resistance, making it a promising option for pediatric patients with adherence difficulties.

CASE PRESENTATION

We report a case of a 2-year-old girl with perinatally acquired HIV who experienced persistent viremia despite multiple ART regimens. The mother received zidovudine prophylaxis during delivery, and the infant was started on zidovudine (AZT) prophylaxis on the first day of life. The patient's ART history included AZT monotherapy at birth, followed by combination therapy with lamivudine (3TC), lopinavir/ritonavir (LPV/r), and later tenofovir/emtricitabine (TDF/FTC) with dolutegravir (DTG). Despite these regimens, poor adherence related to medication administration difficulties and caregiver challenges contributed to persistent viremia. A multidisciplinary team approach was implemented to address adherence barriers. Given the patient's ongoing virological failure and resistance mutations (L76V and V179E), off-label use of BIC/FTC/TAF (50mg/200mg/25mg) was approved. The dosage was adjusted based on weight, and medication administration was closely monitored. Within one month of treatment, HIV RNA levels significantly declined from 1,800,000 to 207 copies/mL. Viral suppression was maintained over subsequent three-month intervals, with HIV RNA levels of 35, 40, and 43 copies/mL, alongside immune recovery as indicated by increased CD4 counts.

CONCLUSION

The successful off-label use of BIC/FTC/TAF in a treatment-refractory pediatric HIV case highlights its potential efficacy in young patients facing adherence challenges. Its high genetic barrier to resistance and favorable tolerability make it a promising option when standard therapies fail. Further research is needed to optimize pediatric ART strategies and expand access to STRs globally.

摘要

背景

坚持抗逆转录病毒疗法(ART)是儿科人类免疫缺陷病毒(HIV)管理中的一项重大挑战,尤其是对于幼儿而言,这是由于药物剂型、给药困难以及社会心理障碍等因素所致。单片复方制剂(STRs)已被证明可提高成人和青少年的依从性及病毒抑制效果,但其在年幼儿童中的应用仍然有限。比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺(BIC/FTC/TAF)是一种对耐药具有高基因屏障的STR,使其成为依从性困难的儿科患者的一个有前景的选择。

病例报告

我们报告一例2岁女童,其通过母婴传播感染HIV,尽管接受了多种抗逆转录病毒治疗方案,但仍出现持续性病毒血症。母亲在分娩期间接受了齐多夫定预防治疗,婴儿在出生第一天开始接受齐多夫定(AZT)预防治疗。该患者的抗逆转录病毒治疗史包括出生时接受AZT单药治疗,随后接受拉米夫定(3TC)、洛匹那韦/利托那韦(LPV/r)联合治疗,后来接受替诺福韦/恩曲他滨(TDF/FTC)与多替拉韦(DTG)联合治疗。尽管采用了这些方案,但与给药困难和照顾者面临的挑战相关的依从性差导致了持续性病毒血症。实施了多学科团队方法来解决依从性障碍。鉴于患者持续的病毒学失败和耐药突变(L76V和V179E),批准了BIC/FTC/TAF(50mg/200mg/25mg)的超说明书用药。根据体重调整剂量,并密切监测给药情况。治疗后一个月内,HIV RNA水平从1,800,000显著下降至207拷贝/mL。在随后的三个月期间维持了病毒抑制,HIV RNA水平分别为35、40和43拷贝/mL,同时CD4细胞计数增加表明免疫功能得到恢复。

结论

BIC/FTC/TAF在一例治疗难治性儿科HIV病例中的成功超说明书用药突出了其在面临依从性挑战的年轻患者中的潜在疗效。其对耐药的高基因屏障和良好的耐受性使其在标准疗法失败时成为一个有前景的选择。需要进一步研究以优化儿科抗逆转录病毒治疗策略并在全球范围内扩大对STRs的可及性。

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