Tronina Olga, Durlik Magdalena, Orłowska Iwona, Lorenc Beata, Łapiński Tadeusz W, Garlicki Aleksander, Dybowska Dorota, Zarębska-Michaluk Dorota, Tudrujek-Zdunek Magdalena, Citko Jolanta, Janczewska Ewa, Kaczmarczyk Marcin, Jaroszewicz Jerzy, Krygier Rafał, Klapaczyński Jakub, Dobracka Beata, Białkowska-Warzecha Jolanta, Piekarska Anna, Simon Krzysztof, Halota Waldemar, Pawłowska Małgorzata, Tomasiewicz Krzysztof, Flisiak Robert
Department of Transplantation Medicine, Nephrology, and Internal Diseases, Medical University of Warsaw, Warsaw (Olga Tronina, Magdalena Durlik).
Department of Infectious Diseases and Hepatology, Wrocław Medical University, Wrocław (Iwona Orłowska, Krzysztof Simon).
Ann Gastroenterol. 2021;34(3):438-446. doi: 10.20524/aog.2021.0595. Epub 2021 Feb 5.
Patients who undergo hemodialysis (HD) or kidney transplantation (KTx) previously had limited possibilities for treatment of hepatitis C virus (HCV) infection. Direct-acting antivirals (DAA) give these patients a chance of virus eradication and safe transplantation. The aim of this study was to evaluate the effectiveness and safety of DAA in KTx and HD patients in real-world settings.
Sustained virologic response (SVR) and treatment safety were analyzed in KTx and HD patients from the EpiTer-2 database, which included HCV-infected subjects treated with DAA between 2015 and 2019. Additionally, for KTx patients, changes in creatinine concentration, estimated glomerular filtration rate (eGFR), proteinuria within a year after treatment, and changes in the need for calcineurin inhibitors were assessed.
Among 10,152 patients from the EpiTer-2 database 148 were selected, 85 after KTx and 63 undergoing HD. The most common genotype, 1b HCV, was found in 73% and 86% of patients, respectively. Cirrhosis was noted in 10% and 19%, respectively. The most common DAA regimen after KTx was sofosbuvir/ledipasvir (54%), whereas in HD patients it was ombitasvir/paritaprevir/ritonavir +/- dasabuvir (56%). All patients with available follow-up results achieved SVR. No deaths, kidney loss or acute rejection episodes were noted. The most common adverse effects in both groups were anemia and weakness. One year after treatment, creatinine concentration, eGFR and proteinuria remained stable in the majority of patients.
DAA treatment of HCV infection demonstrated high effectiveness and safety in hemodialyzed patients and patients who had undergone KTx in this real-world study.
既往接受血液透析（HD）或肾移植（KTx）的患者治疗丙型肝炎病毒（HCV）感染的可能性有限。直接抗病毒药物（DAA）为这些患者提供了根除病毒和安全移植的机会。本研究的目的是评估DAA在实际临床环境中对接受KTx和HD治疗患者的有效性和安全性。
对EpiTer-2数据库中接受KTx和HD治疗的患者的持续病毒学应答（SVR）和治疗安全性进行分析，该数据库纳入了2015年至2019年间接受DAA治疗的HCV感染受试者。此外，对于接受KTx治疗的患者，评估治疗后一年内肌酐浓度、估计肾小球滤过率（eGFR）、蛋白尿的变化以及钙调神经磷酸酶抑制剂需求的变化。
从EpiTer-2数据库的10152例患者中选取了148例，其中85例接受KTx治疗，63例接受HD治疗。最常见的基因型，即HCV 1b型，分别在73%和86%的患者中发现。肝硬化分别在10%和19%的患者中被发现。KTx治疗后最常用的DAA方案是索磷布韦/维帕他韦（54%），而在HD患者中是奥比他韦/帕利哌韦/利托那韦+/-达沙布韦（56%）。所有有随访结果的患者均实现了SVR。未观察到死亡、肾丢失或急性排斥反应事件。两组中最常见的不良反应是贫血和乏力。治疗一年后，大多数患者的肌酐浓度、eGFR和蛋白尿保持稳定。
在这项实际临床研究中，DAA治疗HCV感染在血液透析患者和接受KTx治疗的患者中显示出高有效性和安全性。
