Efficacy and safety of direct-acting antiviral agents for HCV in mild-to-moderate chronic kidney disease.


Journal

Nefrologia
ISSN: 2013-2514
Titre abrégé: Nefrologia (Engl Ed)
Pays: Spain
ID NLM: 101778581

Informations de publication

Date de publication:
Historique:
received: 20 12 2018
revised: 23 03 2019
accepted: 26 03 2019
pubmed: 24 6 2019
medline: 11 3 2021
entrez: 24 6 2019
Statut: ppublish

Résumé

The advent of direct-acting antiviral agents promises to change the management of hepatitis C virus infection (HCV) in patients with chronic kidney disease (CKD), a patient group in which the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a 'real-world' cohort of patients with CKD. We performed an observational single-arm multi-centre study in a large (n=198) cohort of patients with stage 1-3 CKD who underwent antiviral therapy with DAAs for the treatment of HCV. The primary end-point was sustained virologic response (serum HCV RNA <15IU/mL, 12 weeks after treatment ended) (SVR12). We collected data on on-treatment adverse events (AEs), severe AEs, and laboratory abnormalities. The average baseline eGFR (CKD-EPI equation) was 70.06±20.1mL/min/1.72m All-oral, interferon-free therapy with DAAs for chronic HCV in mild-to-moderate CKD was effective and well-tolerated in a 'real-world' clinical setting. Studies are in progress to address whether sustained viral response translates into better survival in this population.

Sections du résumé

BACKGROUND AND AIMS
The advent of direct-acting antiviral agents promises to change the management of hepatitis C virus infection (HCV) in patients with chronic kidney disease (CKD), a patient group in which the treatment of hepatitis C was historically challenging. We investigated the safety and efficacy of all-oral, interferon-free direct-acting antiviral agents for the treatment of hepatitis C in a 'real-world' cohort of patients with CKD.
METHODS
We performed an observational single-arm multi-centre study in a large (n=198) cohort of patients with stage 1-3 CKD who underwent antiviral therapy with DAAs for the treatment of HCV. The primary end-point was sustained virologic response (serum HCV RNA <15IU/mL, 12 weeks after treatment ended) (SVR12). We collected data on on-treatment adverse events (AEs), severe AEs, and laboratory abnormalities.
RESULTS
The average baseline eGFR (CKD-EPI equation) was 70.06±20.1mL/min/1.72m
CONCLUSIONS
All-oral, interferon-free therapy with DAAs for chronic HCV in mild-to-moderate CKD was effective and well-tolerated in a 'real-world' clinical setting. Studies are in progress to address whether sustained viral response translates into better survival in this population.

Identifiants

pubmed: 31229261
pii: S0211-6995(19)30096-7
doi: 10.1016/j.nefro.2019.03.013
pii:
doi:

Substances chimiques

Amides 0
Anilides 0
Antiviral Agents 0
Benzimidazoles 0
Benzofurans 0
Carbamates 0
Cyclopropanes 0
Drug Combinations 0
Imidazoles 0
Lactams, Macrocyclic 0
Pyrrolidines 0
Quinoxalines 0
Sulfonamides 0
glecaprevir and pibrentasvir 0
ombitasvir 2302768XJ8
grazoprevir 4O2AB118LA
Uracil 56HH86ZVCT
elbasvir 632L571YDK
Proline 9DLQ4CIU6V
Simeprevir 9WS5RD66HZ
2-Naphthylamine CKR7XL41N4
dasabuvir DE54EQW8T1
Valine HG18B9YRS7
daclatasvir LI2427F9CI
Ritonavir O3J8G9O825
paritaprevir OU2YM37K86
Sofosbuvir WJ6CA3ZU8B

Types de publication

Journal Article Multicenter Study Observational Study

Langues

eng spa

Sous-ensembles de citation

IM

Pagination

46-52

Informations de copyright

Copyright © 2019. Published by Elsevier España, S.L.U.

Auteurs

Ezequiel Ridruejo (E)

Hepatology Section, Department of Medicine, Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno "CEMIC", Ciudad Autonoma de Buenos Aires, Argentina; Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina; Latin American Liver Research, Educational and Awareness Network (LALREAN), Pilar, Provincia de Buenos Aires, Argentina.

Rebeca Garcia-Agudo (R)

Nephrology Department, La Mancha-Centro Hospital, Alcázar de San Juan, Ciudad Real, Spain.

Manuel Mendizabal (M)

Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina; Latin American Liver Research, Educational and Awareness Network (LALREAN), Pilar, Provincia de Buenos Aires, Argentina.

Sami Aoufi-Rabih (S)

Gastroenterology and Hepatology Department, La Mancha-Centro Hospital, Alcázar de San Juan, Ciudad Real, Spain.

Vivek Dixit (V)

Division of Gastroenterology, Hepatology and Parenteral Nutrition, Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.

Marcelo Silva (M)

Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Pilar, Provincia de Buenos Aires, Argentina; Latin American Liver Research, Educational and Awareness Network (LALREAN), Pilar, Provincia de Buenos Aires, Argentina.

Fabrizio Fabrizi (F)

Division of Nephrology, Maggiore Hospital and IRCCS Foundation, Milano, Italy. Electronic address: fabrizi@policlinico.mi.it.

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