索磷布韦/维帕他韦治疗维持性血液透析终末期肾病合并慢性丙型肝炎病毒感染患者的临床观察

Clinical outcomes of sofosbuvir/velpatasvir in hepatitis C virus-infected patients with end-stage renal disease on maintenance hemodialysis

目的评估真实世界中索磷布韦/维帕他韦(sofosbuvir/velpatasvir,SOF/VEL)治疗终末期肾病接受维持性血液透析合并丙型肝炎病毒(hepatitis C virus,HCV)感染患者的疗效及安全性。方法纳入2020年10月至2021年1月期间在昆山市第一人民医院接受维持性血液透析合并慢性HCV感染的患者。所有患者均接受全剂量的SOF/VEL(400 mg/100 mg)口服治疗,1次/d,持续12周,由血液透析中心医务人员管理。在基线、治疗结束(end of treatment,EOT)、治疗结束后12周(post-treatment week 12,PTW12)及治疗结束后48周(post-treatment week 48,PTW48)时评估HCVRNA定量、肝肾功能、血常规和电解质。主要观察终点是PTW12持续的病毒学应答(HCV-RNA阴性)。通过监测不良事件和实验室检查来评估其安全性。结果本研究共纳入18例维持性血液透析合并慢性HCV感染的患者,其中14例患者接受血液透析的病因为原发性慢性肾小球肾炎。所有患者均为HCV基因1b型;1例患者伴有代偿性肝硬化;HCV感染时长(150.6±47.6)个月。基线HCV-RNA病毒载量在(4.61×10^(6)~4.47×10^(9))U/L之间。所有患者均完成12周SOF/VEL治疗,EOT、PTW12及PTW48时,所有患者HCV-RNA阴性。从基线到PTW48,ALT[19.0(13.8,24.0)U/L比9.0(8.0,10.0)U/L]和AST[18.0(12.5,21.0)U/L比10.0(8.0,12.0)U/L]水平均降低(P<0.05),血小板计数[120.0(108.3,142.8)×10^(9)/L比154.0(131.0,181.8)×10^(9)/L]水平升高(P<0.05)。EOT时血清钾等电解质水平与基线相当。最常见的不良事件为瘙痒、恶心、疲劳。结论在接受维持性血液透析的慢性HCV感染患者中,12周SOF/VEL抗病毒治疗的整体耐受性良好,且长期观察病毒抑制效果良好,研究结果证实真实世界中SOF/VEL可在血液透析中心HCV的消除中发挥作用。

Objective To evaluate the safety and efficacy of 12-week sofosbuvir/velpatasvir(SOF/VEL)in chronic hepatitis C(CHC)patients with end-stage renal disease(ESRD)on maintenance hemodialysis(MHD)in a real-world setting.Methods From October 10,2020 to January 28,2021,18 CHC patients received full-dose sofosbuvir(400 mg)plus velpatasvir(100 mg)once daily for 12 weeks.HCV RNA quantification,hepaticorenal function and electrolytes were assessed at baseline,end of treatment(EOT)and Week 12/48 after discontinuing therapy.Primary outcome was sustained virological response at Week 12 post-treatment(SVR12,HCV RNA negative).Safety profile was evaluated by monitoring adverse events and laboratory parameters.Results A total 18 treatment-naïve CHC patients on MHD were recruited.And 14 of them underwent MHD for primary chronic glomerulonephritis.All of them were of HCV genotype 1b.One patient developed compensated cirrhosis.The average time of HCV infection was(150.6±47.6)month.Baseline HCV-RNA ranged from(4.61×10^(6))U/L to(4.47×10^(9))U/L.And 12-week SOF/VEL treatment was completed and HCV-RNA stayed negative at EOT and PTW12/48.Significant reductions occurred in ALT[19.0(13.8,24.0)U/L vs 9.0(8.0,10.0)U/L]and AST[18.0(12.5,21.0)U/L vs 10.0(8.0,12.0)U/L]from baseline to PTW48(P<0.05).There was a marked rise in blood platelet from baseline to PTW48[120.0(108.3,142.8)×10^(9)/L vs 154.0(131.0,181.8)×10^(9)/L](P<0.05).Serum levels of potassium at EOT were comparable to baseline.The most common adverse events included pruritus,nausea and fatigue.Conclusions The above 12-week treatment of SOF/VEL is well-tolerated and highly efficacious for CHC patients on MHD.The results support the management of uncomplicated HCV cases by nephrologists.It may be scaled up to HCV elimination during MHD.