Laboratory of Immunomolecular Biology, Hospital General Universitario 'Gregorio Marañón', Madrid, Spain.
HIV Med. 2011 Aug;12(7):442-6. doi: 10.1111/j.1468-1293.2010.00907.x. Epub 2011 Mar 13.
We evaluated the efficacy, safety and tolerability of etravirine in paediatric patients vertically infected with HIV-1.
A multicentre retrospective study of 23 multidrug-resistant paediatric patients (five children and 18 adolescents) enrolled in the study from 1 September 2007 to 28 February 2010 was carried out. We performed a longitudinal analysis of immunological, virological and clinical data.
The median age of the patients was 14.2 years [interquartile range (IQR) 12.5-15.8 years]. At baseline, the median HIV-1 RNA was 29 000 (4.5 log(10) ) HIV-1 RNA copies/mL (range 4300-83 000 copies/mL), the median CD4 T-cell count was 445 cells/μL (range 221-655 cells/μL) and the median CD4 percentage was 19.6% (IQR 13.0-31.0). Remarkably, 16 of 23 patients (70%) harboured one or more etravirine-associated resistance mutations. The backbone regimen included at least two fully active drugs in 91% of patients. After etravirine-based therapy, 20 patients (87%) achieved HIV-1 RNA<400 copies/mL and 18 of 23 (78%) achieved HIV-1 RNA<50 copies/mL: three (13%) within the first month, seven (30%) within the first 4 months, and six (26%) between the 5th and 8th months. CD4 T-cell recovery was observed in 19 patients (83%). The median follow-up time was 48.4 weeks (IQR 35.7-63.4 weeks); four patients (17%) were exposed to etravirine for >120 weeks. Three mild/short-term and two moderate skin rashes were observed in the adolescents. Laboratory abnormalities included hypercholesterolaemia (11 of 23 patients), hypertriglyceridaemia (eight of 23 patients), and reduced high-density lipoprotein cholesterol (10 of 23 patients). Adherence was complete in seven patients (30%). No patients showed complete resistance to etravirine after follow-up. However, three of 21 patients (14%) who initially showed intermediate resistance interrupted etravirine treatment because of virological failure.
We observed a sustained antiviral response and improved immunological parameters in multidrug-resistant paediatric patients, most of whom had received etravirine as part of salvage regimens with at least two fully active drugs.
我们评估了依曲韦林在感染 HIV-1 的儿科患者中的疗效、安全性和耐受性。
进行了一项多中心回顾性研究，共纳入 23 名多药耐药儿科患者（5 名儿童和 18 名青少年），他们于 2007 年 9 月 1 日至 2010 年 2 月 28 日入组。我们对免疫、病毒学和临床数据进行了纵向分析。
患者的中位年龄为 14.2 岁[四分位距（IQR）12.5-15.8 岁]。基线时，中位 HIV-1 RNA 为 29000（4.5 log(10)）HIV-1 RNA 拷贝/mL（范围 4300-83000 拷贝/mL），中位 CD4 T 细胞计数为 445 个/μL（范围 221-655 个/μL），中位 CD4 百分比为 19.6%（IQR 13.0-31.0）。值得注意的是，23 名患者中有 16 名（70%）存在一种或多种依曲韦林相关耐药突变。基础方案中至少有两种完全有效的药物在 91%的患者中使用。接受依曲韦林治疗后，20 名患者（87%）HIV-1 RNA<400 拷贝/mL，18 名患者（78%）HIV-1 RNA<50 拷贝/mL：3 名（13%）在第一个月内，7 名（30%）在第 4 个月内，6 名（26%）在第 5-8 个月内。19 名患者（83%）观察到 CD4 T 细胞恢复。中位随访时间为 48.4 周（IQR 35.7-63.4 周）；4 名患者（17%）接受依曲韦林治疗>120 周。18 名青少年中有 3 名出现轻度/短期皮疹，2 名出现中度皮疹。实验室异常包括高胆固醇血症（23 名患者中有 11 名）、高三酰甘油血症（23 名患者中有 8 名）和高密度脂蛋白胆固醇降低（23 名患者中有 10 名）。7 名患者（30%）的依从性完全。随访后没有患者对依曲韦林产生完全耐药。然而，最初表现为中度耐药的 21 名患者中有 3 名（14%）因病毒学失败而中断了依曲韦林治疗。
我们观察到耐药性儿科患者的抗病毒反应持续且免疫参数改善，其中大多数患者在至少两种完全有效的药物基础上，将依曲韦林作为挽救性方案的一部分进行治疗。
