MRC Clinical Trials Unit at UCL, 4919University College London, London, UK.
Clinical Department of Infectious Diseases (HIV Department), Dr. Victor Babeș Hospital for Infectious and Tropical Diseases, Bucharest, Romania.
Antivir Ther. 2022 Jun;27(3):13596535221092182. doi: 10.1177/13596535221092182.
Etravirine (ETR) is approved as a component of second or third-line antiretroviral treatment (ART) for children living with HIV. We assessed the outcomes of ETR-based ART in children in routine care in Europe and Thailand.
Data on children aged <18 years at ETR start were pooled from 17 observational cohorts. Characteristics at ETR start, immunological and virological outcomes at 12 months, discontinuations, adverse events (AEs) and serious adverse events (SAEs) were described. Follow-up was censored at ETR discontinuation, death or last visit.
177 children ever received ETR. At ETR start, median [IQR] age was 15 [12,16] years, CD4 count 480 [287, 713] cells/mm, 70% had exposure to ≥3 ART classes and 20% had viral load (VL) <50 copies/mL. 95% received ETR in combination with ≥1 potent drug class, mostly protease inhibitor-based regimens. Median time on ETR was 24 [7, 48] months. Amongst those on ETR at 12 months (=141), 69% had VL<50 copies/mL. Median CD4 increase since ETR start (=83) was 147 [16, 267] cells/mm. Overall, 81 (46%) discontinued ETR by last follow-up. Median time to discontinuation was 23 [8, 47] months. Common reasons for discontinuation were treatment simplification (19%), treatment failure (16%) and toxicity (12%). Eight children (5%) had AEs causally associated with ETR, all dermatological/hypersensitivity reactions. Two were SAEs, both Stevens-Johnson Syndrome in children on regimens containing ETR and darunavir and were causally related to either drugs; both resolved following ART discontinuation.
Children receiving ETR were predominantly highly treatment-experienced, over two-thirds were virally suppressed at 12 months.
依曲韦林（ETR）获批用于治疗儿童艾滋病毒感染，作为二线或三线抗逆转录病毒治疗（ART）方案的组成部分。我们评估了依曲韦林为基础的 ART 在欧洲和泰国常规护理中儿童患者的治疗结局。
从 17 个观察性队列中汇总了开始依曲韦林治疗时年龄<18 岁的儿童数据。描述了开始依曲韦林治疗时的特征、12 个月时的免疫和病毒学结局、停药、不良事件（AE）和严重不良事件（SAE）。随访截止于依曲韦林停药、死亡或最后一次就诊。
177 名儿童曾接受依曲韦林治疗。依曲韦林开始治疗时，中位（IQR）年龄为 15 [12,16]岁，CD4 计数为 480 [287,713]细胞/mm，70%曾暴露于≥3 种 ART 类别，20%病毒载量（VL）<50 拷贝/mL。95%的患者接受了至少一种强效药物类别的依曲韦林联合治疗，大多是基于蛋白酶抑制剂的方案。中位依曲韦林治疗时间为 24 [7,48]个月。在 12 个月时接受依曲韦林治疗的（=141）患者中，69%VL<50 拷贝/mL。自依曲韦林开始治疗以来，CD4 中位数增加了 83 [16,267]细胞/mm。总体而言，81 名（46%）患者在最后一次随访时停止了依曲韦林治疗。中位停药时间为 23 [8,47]个月。停药的常见原因是治疗简化（19%）、治疗失败（16%）和毒性（12%）。8 名（5%）儿童发生了与依曲韦林相关的 AE，均为皮肤/过敏反应。2 例为 SAE，均为服用包含依曲韦林和达芦那韦方案的儿童发生的 Stevens-Johnson 综合征，均与药物有关；均在 ART 停药后缓解。
接受依曲韦林治疗的儿童主要是高度治疗经验丰富的患者，超过三分之二的患者在 12 个月时病毒得到抑制。
