Real-world direct-acting antiviral treatment in kidney transplant and hemodialysis patients: the EpiTer-2 multicenter observational study

Olga Tronina; Magdalena Durlik; Iwona Orłowska; Beata Lorenc; Tadeusz W. Łapiński; Aleksander Garlicki; Dorota Dybowska; Dorota Zarębska-Michaluk; Magdalena Tudrujek-Zdunek; Jolanta Citko; Ewa Janczewska; Marcin Kaczmarczyk; Jerzy Jaroszewicz; Rafał Krygier; Jakub Klapaczyński; Beata Dobracka; Jolanta Białkowska-Warzecha; Anna Piekarska; Krzysztof Simon; Waldemar Halota; Małgorzata Pawłowska; Krzysztof Tomasiewicz; Robert Flisiak

Authors Olga Tronina, Magdalena Durlik, Iwona Orłowska, Beata Lorenc, Tadeusz W. Łapiński, Aleksander Garlicki, Dorota Dybowska, Dorota Zarębska-Michaluk, Magdalena Tudrujek-Zdunek, Jolanta Citko, Ewa Janczewska, Marcin Kaczmarczyk, Jerzy Jaroszewicz, Rafał Krygier, Jakub Klapaczyński, Beata Dobracka, Jolanta Białkowska-Warzecha, Anna Piekarska, Krzysztof Simon, Waldemar Halota, Małgorzata Pawłowska, Krzysztof Tomasiewicz, Robert Flisiak.

Abstract

Background Patients who undergo hemodialysis (HD) or kidney transplantation (KTx) previously had limited possibilities for treatment of hepatitis C virus (HCV) infection. Directacting 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.

Methods 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.

Results 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.

Conclusion DAA treatment of HCV infection demonstrated high effectiveness and safety in hemodialyzed patients and patients who had undergone KTx in this real-world study.

Keywords Antiviral treatment, chronic hepatitis C infection, direct-acting antivirals, hemodialysis, kidney transplantation

Ann Gastroenterol 2021; 34 (3): 438-446