以索磷布韦为基础的直接抗病毒方案治疗慢性丙型肝炎儿童及青少年的疗效和安全性分析  

Efficacy and safety of sofosbuvir-based direct-acting antiviral treatment in children and adolescent patients with chronic hepatitis C

作　　者：刘立 李梅 常丽仙 方铭 李惠敏 牟春燕 张映媛 李俊义 刘春云 Liu Li;Li Mei;Chang Lixian;Fang Ming;Li Huimin;Mou Chunyan;Zhang Yingyuan;Li Junyi;Liu Chunyun(Department of Liver Disease,Yunnan Provincial Center for Infectious Diseases Clinical Medicine,The Third People′s Hospital of Kunming City,Kunming 650041,China;Department of Infectious Diseases,The People′s Hospital of Fuyuan County,Qujing 655500,China)

机构地区：[1]昆明市第三人民医院、云南省传染性疾病临床医学中心肝病科,昆明650041 [2]富源县人民医院感染科,曲靖655500

出　　处：《中华传染病杂志》2023年第5期320-325,共6页Chinese Journal of Infectious Diseases

摘　　要：目的探索以索磷布韦为基础的直接抗病毒方案对慢性丙型肝炎(CHC)儿童及青少年的疗效和安全性。方法纳入2018年1月至2022年8月就诊于昆明市第三人民医院和富源县人民医院的52例3~17岁CHC儿童和青少年患者,收集其基本资料,给予索磷布韦/维帕他韦(SOF/VEL)或来迪派韦/索磷布韦(LDV/SOF)±利巴韦林治疗12周,观察患儿治疗前、治疗后和停药随访12周的生物化学指标、病毒学指标。主要疗效指标为治疗结束后随访12周时患儿获得持续病毒学应答(SVR)和治疗期间的不良事件发生情况。统计学分析采用非参数检验。结果52例CHC患儿中,儿童38例,青少年14例;男31例,女21例;年龄为9(7,12)岁。52例患儿中,1b型7例,2a型11例,3型2例,3a型5例,3b型18例,6a型1例,6k型3例,6n型4例,6v型1例。垂直传播12例(23.1%),家庭间水平传播21例(40.4%),血液传播2例(3.8%),不详17例(32.7%)。与基线相比,患儿治疗12周、停药12周后总胆红素、丙氨酸转氨酶、天冬氨酸转氨酶水平均下降,差异均有统计学意义(F=12.71、30.23、42.52,均P<0.05)。截至2022年9月30日,100.0%(52/52)的患儿在治疗结束时获得SVR,完成12周随访的患儿中,95.8%(46/48)获得SVR。治疗期间常见的不良事件包括乏力[11.5%(6/52)]、头痛[5.8%(3/52)]、头晕[1.9%(1/52)]、腹痛[3.8%(2/52)]、腹泻[1.9%(1/52)]、皮疹[1.9%(1/52)]、皮肤瘙痒[1.9%(1/52)],无患儿因为不良反应停药。结论以索磷布韦为基础的直接抗病毒方案治疗CHC儿童及青少年的疗效和耐受性良好,没有因不良事件导致的停药。Objective To explore the efficacy and safety of sofosbuvir-based direct-acting antiviral treatment in children and adolescent patients with chronic hepatitis C(CHC).Methods A total of 52 children and adolescent patients who admitted to The Third People′s Hospital of Kunming City and The People′s Hospital of Fuyuan County aged from three to 17 years old with CHC from January 2018 to August 2022 were enrolled,and their basic information was collected.Patients were treated with sofosbuvir/velpatasvir(SOF/VEL)or ledipasvir/sofosbuvir(LDV/SOF)with or without ribavirin for 12 weeks.The biochemical and virological indexes were followed up before and after treatment and 12 weeks after withdrawal.The primary endpoint was the sustained virological response(SVR)at week 12 of follow-up after treatment,and the occurrence of adverse events(AE)during treatment.Statistical analysis was used by nonparametric test.Results A total of 52 patients with CHC including 38 children and 14 adolescents were enrolled.Thirty-one were male and 21 were female.The age was 9(7,12)years old.Among 52 patients,seven patients were type 1b,11 were type 2a,three were type 2,five were type 3a,18 were type 3b,one was type 6a,three were type 6k,four were type 6n and one was type 6v.Twelve(23.1%)patients were vertical transmission,21(40.4%)patients had horizontal transmission among family members,two(3.8%)patients were blood fluid transmission,and 17(32.7%)were unknown transmission route.Compared with the baseline levels,Total bilirubin,alanine aminotransferase and aspartate aminotransferase were all significantly decreased after 12 weeks of treatment and 12 weeks after withdrawal,and the differences were statistically significant(F=12.71,30.23 and 42.52,respectively,all P<0.05).Up to September 30,2022,100.0%(52/52)of patients achieved SVR at the end of treatment.For patients who completed follow-up for 12 weeks after treatment,95.8%(46/48)achieved SVR.Common AEs during treatment were fatigue(11.5%(6/52)),headache(5.8%(3/52)),dizziness(1.9%(1/52)),abd

关 键 词：丙型肝炎病毒 儿童 青少年 索磷布韦 维帕他韦 来迪派韦 

分 类 号：R512.63[医药卫生—内科学]