Real-world direct-acting antiviral treatment in kidney transplant and hemodialysis patients: the EpiTer-2 multicenter observational study.
Antiviral treatment
chronic hepatitis C infection
direct-acting antivirals
hemodialysis
kidney transplantation
Journal
Annals of gastroenterology
ISSN: 1108-7471
Titre abrégé: Ann Gastroenterol
Pays: Greece
ID NLM: 101121847
Informations de publication
Date de publication:
2021
2021
Historique:
received:
13
09
2020
accepted:
22
10
2020
entrez:
5
5
2021
pubmed:
6
5
2021
medline:
6
5
2021
Statut:
ppublish
Résumé
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.
Sections du résumé
BACKGROUND
BACKGROUND
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.
METHODS
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
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
CONCLUSIONS
DAA treatment of HCV infection demonstrated high effectiveness and safety in hemodialyzed patients and patients who had undergone KTx in this real-world study.
Identifiants
pubmed: 33948071
doi: 10.20524/aog.2021.0595
pii: AnnGastroenterol-34-438
pmc: PMC8079881
doi:
Types de publication
Journal Article
Langues
eng
Pagination
438-446Informations de copyright
Copyright: © 2021 Hellenic Society of Gastroenterology.
Déclaration de conflit d'intérêts
Conflict of Interest: Dorota Zarębska-Michaluk: Sponsored Lectures: AbbVie, Gilead, Merck Jerzy Jaroszewicz: Sponsored lectures: AbbVie, Bristol-Myers Squib, DiaSorin, Gilead, Grifols, Roche, Woerwag, MSD Sharp&Dohme/Merck; Member of the scientific advisory boards of AbbVie, Bristol-Myers Squib, Gilead Sciences, MSD Sharp & Dohme/ Merck and Roche Krzysztof Simon: Consultancy: AbbVie, Abbott, Gilead, MSD, GSK, Janssen, AlfaSigma, Baxter, Promed; Research Funding: Bayer, Gilead, EISAI, AbbVie, Tobira, Intercept, MSD, Janssen, Takeda, Actelion, GSK, Pfizer, BeiGene, Allergan, Summit (Oxford) Małgorzata Pawłowska: Consultancy: AbbVie, Gilead, Merck, Roche; Sponsored Lectures: AbbVie, Gilead, Merck Krzysztof Tomasiewicz: Consultancy: AbbVie, Alfa Wasserman, BMS, Gilead, Janssen, Merck, Roche; Research funding: AbbVie, BMS, Gilead, Janssen, Merck, Roche Robert Flisiak: Consultancy and Research funding: AbbVie, Gilead, Janssen, Merck, Roche
Références
Transpl Int. 2014 Sep;27(9):877-91
pubmed: 24853721
Liver Int. 2016 Jan;36 Suppl 1:28-33
pubmed: 26725894
Virol J. 2019 Mar 14;16(1):34
pubmed: 30871566
Clin Transplant. 2017 May;31(5):
pubmed: 28239909
N Engl J Med. 2017 Jun 15;376(24):2394-2395
pubmed: 28459186
J Hepatol. 2020 Nov;73(5):1170-1218
pubmed: 32956768
Clin Exp Hepatol. 2017 Jun;3(2):47-55
pubmed: 28856290
Transplant Direct. 2018 Dec 27;5(1):e419
pubmed: 30656217
N Engl J Med. 2017 Oct 12;377(15):1448-1455
pubmed: 29020583
Ann Intern Med. 2017 Jan 17;166(2):109-117
pubmed: 27842383
Clin Dev Immunol. 2012;2012:740138
pubmed: 22919404
Semin Dial. 2017 Sep;30(5):395-397
pubmed: 28786139
Lancet. 2015 Oct 17;386(10003):1537-45
pubmed: 26456905
Hepatology. 2018 Oct;68(4):1298-1307
pubmed: 29672891
J Hepatol. 2018 Aug;69(2):461-511
pubmed: 29650333
Kidney Int. 2018 Mar;93(3):560-567
pubmed: 29325996
J Hepatol. 2016 Oct;65(1 Suppl):S82-S94
pubmed: 27641990
Clin Kidney J. 2018 Jun;11(3):429-433
pubmed: 29942507
Transpl Int. 2009 Dec;22(12):1117-31
pubmed: 19656350
Hepatol Res. 2020 May;50(5):557-564
pubmed: 31883211
J Viral Hepat. 2018 Jun;25(6):661-669
pubmed: 29316039
Transpl Infect Dis. 2017 Aug;19(4):
pubmed: 28509330
Semin Dial. 2011 May-Jun;24(3):272-4
pubmed: 21480995
Clin Exp Hepatol. 2020 Sep;6(3):163-169
pubmed: 33145422
Transplantation. 2017 May;101(5):980-986
pubmed: 27495770
N Engl J Med. 2017 Sep 14;377(11):1105
pubmed: 28902585
Kidney Int Suppl (2011). 2018 Oct;8(3):91-165
pubmed: 30675443
Gastroenterol Hepatol (N Y). 2018 May;14(5):280-285
pubmed: 29991935
Am J Transplant. 2018 Oct;18(10):2443-2450
pubmed: 29687948
Transplantation. 2018 Mar;102(3):454-460
pubmed: 28976413
Pol Arch Intern Med. 2020 Feb 27;130(2):163-172
pubmed: 32031541
Liver Int. 2020 May;40(5):1032-1041
pubmed: 31821716
Kidney Int Rep. 2018 Oct 09;4(2):257-266
pubmed: 30775622
Am J Transplant. 2014 Oct;14(10):2206-20
pubmed: 25091274
Pathog Immun. 2020 Sep 30;5(1):275-290
pubmed: 33089036
Am J Transplant. 2016 May;16(5):1474-9
pubmed: 26587971