索磷布韦为基础的直接抗病毒药物治疗儿童慢性丙型肝炎的疗效及安全性

Efficacy and safety of sofosbuvir-based direct antiviral therapy for chronic hepatitis C in children

目的评价索磷布韦(Sofosbuvir,SOF)为基础的直接抗病毒药物治疗儿童慢性丙型肝炎(chronic hepatitis C,CHC)的疗效及安全性。方法收集2017年5月至2019年12月诊断为CHC的儿童,接受SOF(体质量≥17 kg 200 mg/d,<17 kg 150 mg/d)/雷迪帕韦(Ledipasvir,LDV,体质量≥17 kg 45 mg/d,<17 kg 33.75 mg/d)或维帕他韦(Velpatasvir,VEL,体质量≥17 kg 50 mg/d,<17 kg 35 mg/d)±利巴韦林(RBV,15 mg/kg/d)治疗12周,停药随访12周的资料。主要疗效指标为治疗结束和停药随访12周时获得持续病毒学应答(SVR);并观察治疗期不良事件发生情况,以评价药物的安全性。结果13例儿童中10例(76.92%)儿童均在抗病毒治疗后2周内HCV RNA转阴,2例(15.38%)在2~4周内HCVRNA转阴,1例(7.69%)患者在8周HCV RNA未转阴时加用RBV,第10周复查HCV RNA转阴。停抗病毒药物后12周和24周(SVR12,SVR24)复查HCV RNA持续阴性。不良反应:头痛2例(15.38%)、3例乏力(23.08%),无1例出现严重不良反应。结论索林布韦为基础的直接抗病毒药物治疗儿童慢性丙型肝炎的疗效及安全性良好。

Objective To evaluate the efficacy and safety of direct antiviral drugs based on sofosbuvir in the treatment of chronic hepatitis C in children.Methods Data of children diagnosed with chronic hepatitis C from May 2017 to December 2019 and received sofosbuvir(SOF,body weight≥17 kg 200 mg/d,<17 kg 150 mg/d)/ledipasvir(LDV,body mass≥17 kg 45 mg/d,<17 kg 33.75 mg/d)or velpatasvir(VEL,body weight≥17 kg 50 mg/d),were collected.The patients were treated with ribavirin(RBV,15 mg/kg·d)for 12 weeks and followed up for 12 weeks.The main outcome measures were sustained virological response(SVR)at 12 weeks follow-up after drug discontinuation,and the occurrence of adverse events during the treatment period was observed to evaluate the safety of the drug.Results HCV RNA turned negative in 10 of the 13 children(76.92%),within 2 weeks after antiviral treatment,in 2 cases(15.38%)HCV RNA turned negative in 2-4 weeks,in 1 case(7.69%)RBV was added when HCV RNA did not turn negative in 8 weeks,but turned negative at 10 weeks.At 12 and 24 weeks after discontinuation of antiviral drugs(SVR12),HCV RNA continued to be negative,and at 24 weeks(SVR24),it was also negative.Adverse reactions:headache occurred in 2 cases(15.38%),fatigue in 3 cases(23.08%),no serious adverse reactions occurred in any of the patients.Conclusions The efficacy and safety of direct antiviral drugs based on SOF in the treatment of children with chronic hepatitis C were good.