'Real-life' experience with direct-acting antiviral agents for HCV after kidney transplant.
2-Naphthylamine
/ therapeutic use
Administration, Oral
Adult
Aged
Anilides
/ therapeutic use
Antiviral Agents
/ therapeutic use
Benzofurans
Cohort Studies
Creatinine
/ blood
Cyclopropanes
/ therapeutic use
Drug Combinations
Female
Glomerular Filtration Rate
Hepatitis C
/ complications
Humans
Imidazoles
Kidney Transplantation
Lactams, Macrocyclic
/ therapeutic use
Male
Middle Aged
Proline
/ analogs & derivatives
Quinoxalines
Ribavirin
/ therapeutic use
Ritonavir
/ therapeutic use
Sofosbuvir
/ therapeutic use
Sulfonamides
/ therapeutic use
Sustained Virologic Response
Uracil
/ analogs & derivatives
Valine
/ therapeutic use
Antiviral agents
Chronic kidney disease
Hepatitis C
Kidney transplant
Viral response
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
100337Informations de copyright
Copyright © 2021 AEDV. Published by Elsevier España, S.L.U. All rights reserved.