半量索磷布韦联合全量达卡他韦治疗终末期肾病合并慢性丙型肝炎患者疗效和耐受性评价  

Efficacy and safety of sofosbuvir and dacatavir combination in the treatment of patients with end-stage renal disease and concomitant chronic hepatitis C

作　　者：乔进[1] 赵彦 窦志华[1] Qiao Jin;Zhao Yan;Dou Zhihua(Department of Pharmacy,Third People's Hospital,Affiliated to Nantong University,Nantong 226006,Jiangsu Province,China)

机构地区：[1]南通大学附属第三医院,南通市第三人民医院药学部,江苏省南通市226006 [2]南通大学附属南通市第三人民医院院长办公室,江苏省南通市226006

出　　处：《实用肝脏病杂志》2024年第6期844-847,共4页Journal of Practical Hepatology

基　　金：江苏省卫健委重点科研项目(编号:ZD2021061);南通市卫健委青年医学人才科研基金资助项目(编号:WR2017011)。

摘　　要：目的评估索磷布韦联合达卡他韦治疗终末期肾病合并慢性丙型肝炎(CHC)患者的疗效和耐受性。方法2020年5月~2022年5月我院诊治的接受维持性血液透析治疗的终末期肾病合并CHC患者42例,均接受索磷布韦联合达卡他韦治疗12 w。采用Simmonds基因分型法进行HCV基因型鉴定,定期评估快速病毒学应答(RVR)、治疗结束病毒学应答(ETVR)、停药6个月持续病毒学应答(SVR6)和停药12个月持续病毒学应答(SVR12)。结果本组终末期肾病合并1b、2a、2b和3型HCV感染患者分别为22例、9例、6例和5例;除基因3型感染者SVR6和SVR12为80.0%外,其他各型HCV感染者RVR、ETVR和SVR均为100.0%(P>0.05);在随访12 m,42例患者血清ALT为23(20,38)U/L,AST为21(17,35)U/L,显著低于基线水平【分别为61(42,92)U/L和59(45,83)U/L,P<0.05】,而外周血血小板计数为155(130,194)×10^(9)/L,估算的肾小球滤过率(eGFR)为14.9(12.5,17.3)ml/min×1.73 m^(2),均显著高于基线水平【分别为122(98,141)×10^(9)/L和9.3(8.0,11.5)ml/min×1.73m^(2),P<0.05】;在治疗前后,所有患者血清肌酐(sCr)和尿素(BUN)水平无显著性变化(P>0.05);在直接抗病毒药物(DAAs)治疗过程中,出现8种共55例次不良事件,如恶心、疲劳、瘙痒、食欲减退、高钾血症、低血糖、高血压和关节疼痛等,总体耐受性良好,无因不良事件导致治疗非计划终止。结论应用索非布韦联合达卡他韦治疗终末期肾病合并CHC患者疗效可靠,副作用较小,值得扩大临床研究。Objective The aim of this study was to investigate efficacy and safety of sofosbuvir and dacatavir combination in the treatment of patients with end-stage renal disease(ESRD)and concomitant chronic hepatitis C(CHC).Methods 42 CHC patients with ESRD were encountered in our hospital between May 2020 and May 2022,and all underwent maintenance hemodialysis.DAAs regimen was carried out by sorfosbuvir and dacatavir combination for all patients for 12 weeks and followed-up for 12 months.HCV genotypes was conducted by Simmonds gene typing.Rapid virological response(RVR),end of treatment virological response(ETVR),sustained virologic response six month(SVR6)and SVR12 were recorded.Results Genotypes infected in our series were 1b in 22 cases,2a in 9 cases,2b in 6 cases and 3 in 5 cases;except for SVR6 and SVR12 were 80.0%in patients with genotype 3 infection,the RVR,ETVR and SVR6 and SVR12 were all 100.0%(P>0.05)in patients with other three HCV genotype infection;by end of 12 month follow-up,serum ALT level in 42 patients with CHC was 23(20,38)U/L,AST was 21(17,35)U/L,both significantly lower than[61(42,92)U/L and 59(45,83)U/L,respectively,P<0.05]at baseline,while peripheral blood platelet count was 155(130,194)×10^(9)/L,and estimated glomerular filtration rate(eGFR)was 14.9(12.5,17.3)ml/min×1.73 m^(2),both significantly higher than[122(98,141)×10^(9)/L and 9.3(8.0,11.5)ml/min×1.73m^(2),respectively,P<0.05]at baseline;there were no significant differences as respect to serum creatinine and urea levels before and after antiviral treatment(P>0.05);during direct antiviral agent(DAA)therapy,incidence of eight adverse events,including nausea,fatigue,itching,anorexia,hyperkalemia,hypoglycemia,hypertension and joint pain occurred in 55 episodes.Conclusion Application of DAA in dealing with patients with ESRD and complicated CHC have a satisfactory efficacy and safety,which warrants further clinical investigation.

关 键 词：丙型肝炎 终末期肾病 索非布韦 达卡他韦 治疗 安全性 

分 类 号：R51[医药卫生—内科学]