'Real-life' experience with direct-acting antiviral agents for HCV after kidney transplant.


Journal

Annals of hepatology
ISSN: 1665-2681
Titre abrégé: Ann Hepatol
Pays: Mexico
ID NLM: 101155885

Informations de publication

Date de publication:
Historique:
received: 11 01 2021
revised: 17 02 2021
accepted: 18 02 2021
pubmed: 9 3 2021
medline: 16 3 2022
entrez: 8 3 2021
Statut: ppublish

Résumé

The introduction of direct-acting antiviral (DAA) agents promises to change dramatically the management of hepatitis C in kidney transplant recipients, a patient group where the treatment of hepatitis C is historically challenging. The purpose of the current study was to assess (in a 'real-life' setting) the safety and efficacy of all-oral, interferon-free, direct-acting antiviral agents in kidney transplant recipients with HCV. We performed a single-arm, multi-center study in a cohort (n = 95) of kidney transplant recipients who underwent antiviral therapy with DAAs. The primary end-point was sustained virologic response (SVR) (serum HCV RNA < 15 IU/mL, 12 weeks after treatment ended; SVR12). We recorded data on on-treatment adverse events (AEs), serious AEs, and laboratory abnormalities. Various regimens were adopted at the discretion of the treating physician: elbasvir/grazoprevir (n = 11), paritaprevir/ritonavir/ombitasvir/dasabuvir (PrOD) regimens ± ribavirin (n = 23), and sofosbuvir-based regimens ± ribavirin (n = 61). The SVR12 rate was 93.7% (89/95) (95% CI, 88%; 98%), according to intention-to-treat analysis; three patients without viral response (n = 3) were found. Ribavirin was administered in 8 (8.4%) allograft recipients. The frequency of drop-outs was 4.2% (4/95) (95% CI, 0.2%; 8.2%); these were related to arthralgia/myalgia (n = 2), fatigue (n = 1), and lowered estimated glomerular filtration rate (eGFR) (n = 1). There were no differences with regard to serum creatinine and eGFR before and after antiviral therapy and during follow-up in the whole cohort. The patient who interrupted antiviral treatment due to raised serum creatinine was on sofosbuvir/daclatasvir regimen; one of the four drop-outs obtained SVR. All-oral, interferon-free therapy with DAAs for chronic HCV after kidney transplantation was effective and well-tolerated in a 'real-life' clinical setting. Identical results have been observed in patients with intact kidneys or advanced chronic kidney disease. Careful evaluation of kidney function over follow-up in kidney transplant recipients who received DAAs regimens is recommended. Clinical trials aimed to assess whether sustained viral response translates into improved patient/graft survival are under way.

Identifiants

pubmed: 33684523
pii: S1665-2681(21)00036-3
doi: 10.1016/j.aohep.2021.100337
pii:
doi:

Substances chimiques

Anilides 0
Antiviral Agents 0
Benzofurans 0
Cyclopropanes 0
Drug Combinations 0
Imidazoles 0
Lactams, Macrocyclic 0
Quinoxalines 0
Sulfonamides 0
elbasvir-grazoprevir drug combination 0
ombitasvir 2302768XJ8
Ribavirin 49717AWG6K
Uracil 56HH86ZVCT
Proline 9DLQ4CIU6V
Creatinine AYI8EX34EU
2-Naphthylamine CKR7XL41N4
dasabuvir DE54EQW8T1
Valine HG18B9YRS7
Ritonavir O3J8G9O825
paritaprevir OU2YM37K86
Sofosbuvir WJ6CA3ZU8B

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

100337

Informations de copyright

Copyright © 2021 AEDV. Published by Elsevier España, S.L.U. All rights reserved.

Auteurs

Fabrizio Fabrizi (F)

Nephrology Division, IRCCS Ca' Granda Foundation and Maggiore Policlinico Hospital, Milano, Italy. Electronic address: fabrizio.fabrizi@policlinico.mi.it.

Cristina Alonso (C)

Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina.

Ana Palazzo (A)

Gastroenterology and Hepatology Division, Hospital Padilla, Tucumàn, Argentina.

Margarita Anders (M)

Gastroenterology and Hepatology Division, Hospital Alemàn, Ciudad de Buenos Aires, Argentina.

Maria Virginia Reggiardo (MV)

Gastroenterology and Hepatology Division, Hospital Provincial del Centenario, Rosario, Argentina.

Hugo Cheinquer (H)

Gastroenterology and Hepatology Division, Universidad de Federal do Rio Grande do Sul, Porto Alegre, Brazil.

Maria Grazia Videla Zuain (MGV)

Gastroenterology and Hepatology Division, Hospital Zubizarreta, Ciudad de Buenos Aires, Argentina.

Sebastian Figueroa (S)

Gastroenterology and Hepatology Division, Hospital Arturo Onativia, Salta, Argentina.

Manuel Mendizabal (M)

Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina.

Marcelo Silva (M)

Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina.

Ezequiel Ridruejo (E)

Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina; Hepatology Section, Department of Medicine, Centro de Educaciòn Medica e Investigaciones Clinicas Norberto Quirno "CEMIC", Ciudad Autònoma de Buenos Aires, Argentina.

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Classifications MeSH