Paediatric and Liver Unit, Meyer Children's University Hospital of Florence, Firenze, Italy.
Department NEUROFARBA, University of Florence, Florence, Italy.
Aliment Pharmacol Ther. 2020 Oct;52(7):1125-1133. doi: 10.1111/apt.16037. Epub 2020 Aug 18.
The effect of direct-acting anti-virals (DAAs) in children and adolescents with chronic hepatitis C virus (HCV) infection is difficult to determine, since few, aged between 3 and 18 years, have been enrolled in clinical trials, and some data come from observational studies.
To summarise the evidence on efficacy and safety of DAAs in children and adolescents with chronic HCV infection.
We performed a systematic review and meta-analysis of prospective studies on the efficacy and safety of DAAs in subjects <18 years of age. We considered the sustained virological response at post-treatment week 12 as efficacy outcome and adverse events as safety outcome. We considered intervention effect for each study arm by calculating the proportion of sustained virologic response at post-treatment week 12 in subjects receiving all doses of treatment and proportion of adverse events in subjects receiving at least one dose of treatment. Pooled proportions were calculated using the Freeman-Tukey double arcsine transformation. Random effects model was used for all analyses.
Among 39 included studies (1796 subjects), the pooled proportion among those receiving all doses of treatment and reaching sustained virologic response at post-treatment week 12 was 100% (95% confidence interval: 100-100). Considering subjects receiving at least one dose of treatment, lowest estimates were reported among children with cirrhosis (83%). Headache and fatigue were the most common adverse events. Serious adverse events were uncommon.
Children and adolescents with chronic HCV infection can be safely treated with DAAs with similar efficacy as reported in adults.
直接作用抗病毒药物（DAAs）在慢性丙型肝炎病毒（HCV）感染儿童和青少年中的疗效难以确定，因为只有少数年龄在 3 至 18 岁的儿童和青少年被纳入临床试验，并且一些数据来自观察性研究。
总结 DAA 在慢性 HCV 感染儿童和青少年中的疗效和安全性证据。
我们对年龄<18 岁的患者使用 DAA 的疗效和安全性的前瞻性研究进行了系统评价和荟萃分析。我们将治疗后第 12 周的持续病毒学应答作为疗效终点，将不良事件作为安全性终点。我们通过计算接受所有剂量治疗的患者的持续病毒学应答率和接受至少一剂治疗的患者的不良事件发生率来考虑每个研究组的干预效果。使用 Freeman-Tukey 双反正弦变换计算汇总比例。所有分析均采用随机效应模型。
在 39 项纳入的研究（1796 名患者）中，接受所有剂量治疗且在治疗后第 12 周达到持续病毒学应答的患者比例为 100%（95%置信区间：100-100）。考虑到接受至少一剂治疗的患者，肝硬化儿童的最低估计值为 83%。头痛和疲劳是最常见的不良事件。严重不良事件并不常见。
慢性 HCV 感染的儿童和青少年可以安全地使用 DAA 治疗，疗效与成人报告的相似。
