Evaluation of long-term outcomes of direct acting antiviral agents in chronic kidney disease subjects: a single center cohort study.

Abstract: Background: Chronic kidney disease (CKD) population, including kidney transplant recipients (KTRs) and subjects on renal replacement therapy, is particularly vulnerable to unfa-vorable outcomes of chronic hepatitis C (CHC). Currently, there are oral direct- acting antiviral agents (DAAs) available to eradicate the virus with favorable short-terms outcomes, however long-term effects are lacking. The aim of the study was to assess long-term efficacy and safety of DAA therapy in CKD population. Methods: An observational, cohort single-center study was performed. Fifty-nine CHC subjects with CKD, treated with DAAs between 2016 and 2018 were enrolled to the study. Safety and efficacy profiles were assessed, including sustained virologic response (SVR), occult hepatitis C infection (OCI) incidence and liver fibrosis. Results: SVR was achieved in 96 % of cases (n=57). OCI was diagnosed only in one subject following SVR. Signifi-cant Liver stiffness regression has been observed 4 years following SVR compered to baseline values (Mdn = 6.1 kPa, IQR = 3.75 kPa; 4.9 kPa,IQR = 2.9 kPa), p <0.001. Most common adverse events were anemia, weakness and urinary tract infection. Conclusion: DAAs provide a safe and effective cure for CHC in both CKD patients and KTRs with favorable safety profile in the long-term follow-up.

摘要：
背景：慢性肾脏病（Chronic Kidney Disease, CKD）人群，包括肾移植受者（Kidney Transplant Recipients, KTRs）以及接受肾脏替代治疗的受试者，尤其容易出现慢性丙型肝炎（Chronic Hepatitis C, CHC）的不良转归。目前已有口服直接抗病毒药物（Direct-Acting Antiviral Agents, DAAs）可根除该病毒，且短期疗效良好，但相关长期疗效数据仍存在缺口。本研究旨在评估直接抗病毒药物治疗慢性肾脏病人群的长期疗效与安全性。
方法：本研究为单中心观察性队列研究。纳入2016至2018年间接受直接抗病毒药物治疗的59例合并慢性肾脏病的慢性丙型肝炎受试者。对研究的安全性与有效性指标进行评估，包括持续病毒学应答（Sustained Virologic Response, SVR）、隐匿性丙型肝炎感染（Occult Hepatitis C Infection, OCI）发生率以及肝纤维化情况。
结果：96%的受试者（n=57）获得了持续病毒学应答。仅1例在获得持续病毒学应答后被诊断为隐匿性丙型肝炎感染。与基线值（中位数[Mdn]=6.1 kPa，四分位距[IQR]=3.75 kPa）相比，获得持续病毒学应答4年后可见显著的肝脏硬度下降（中位数=4.9 kPa，四分位距=2.9 kPa），差异具有统计学意义（p<0.001）。最常见的不良事件为贫血、乏力与尿路感染。
结论：直接抗病毒药物可安全有效地治愈合并慢性肾脏病及肾移植受者的慢性丙型肝炎，且在长期随访中展现出良好的安全性特征。