The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment.
Antiviral Agents
/ administration & dosage
Carbamates
Drug Therapy, Combination
Female
Hepatitis C
/ complications
Humans
Imidazoles
/ administration & dosage
Liver Cirrhosis
/ complications
Male
Pyrrolidines
Renal Dialysis
Renal Insufficiency
/ complications
Safety
Severity of Illness Index
Sofosbuvir
/ administration & dosage
Sustained Virologic Response
Treatment Outcome
Valine
/ analogs & derivatives
Hepatitis C
daclatasvir
renal insufficiency
sofosbuvir
Journal
Journal of gastroenterology and hepatology
ISSN: 1440-1746
Titre abrégé: J Gastroenterol Hepatol
Pays: Australia
ID NLM: 8607909
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
19
11
2019
revised:
19
01
2020
accepted:
26
01
2020
pubmed:
30
1
2020
medline:
5
11
2020
entrez:
30
1
2020
Statut:
ppublish
Résumé
Many of the treatment regimens available for hepatitis C include sofosbuvir. Unfortunately, sofosbuvir has not been recommended for use in patients with severe renal impairment leaving these group of patients with very few options. Nevertheless, there are many reports in which these patients have been treated with sofosbuvir-containing regiments without important adverse events. This study aims at determining the safety and effectiveness of a sofosbuvir-based treatment in patients with severe renal impairment, including those on hemodialysis. We enrolled subjects with hepatitis C and estimated glomerular filtration rate under ml/min/1.73m A total of 103 patients were enrolled from 13 centers. Seventy-five patients were on hemodialysis. Thirty-nine had cirrhosis and eight were decompensated. Fifty-three were Genotype 1, and 27 Genotype 3. Twenty-seven patients had history of previous failed interferon-based treatment. Three patients died in which cause of death was not related to treatment. Six patients were lost to follow-up. The remaining 94 patients all achieved SVR. No adverse events leading to discontinuation of medicine was observed. The combination of sofosbuvir and daclatasvir is an effective and safe treatment for patients infected with all genotypes of hepatitis C who have severe renal impairment, including patients on hemodialysis.
Sections du résumé
BACKGROUND AND AIM
OBJECTIVE
Many of the treatment regimens available for hepatitis C include sofosbuvir. Unfortunately, sofosbuvir has not been recommended for use in patients with severe renal impairment leaving these group of patients with very few options. Nevertheless, there are many reports in which these patients have been treated with sofosbuvir-containing regiments without important adverse events. This study aims at determining the safety and effectiveness of a sofosbuvir-based treatment in patients with severe renal impairment, including those on hemodialysis.
METHOD
METHODS
We enrolled subjects with hepatitis C and estimated glomerular filtration rate under ml/min/1.73m
RESULTS
RESULTS
A total of 103 patients were enrolled from 13 centers. Seventy-five patients were on hemodialysis. Thirty-nine had cirrhosis and eight were decompensated. Fifty-three were Genotype 1, and 27 Genotype 3. Twenty-seven patients had history of previous failed interferon-based treatment. Three patients died in which cause of death was not related to treatment. Six patients were lost to follow-up. The remaining 94 patients all achieved SVR. No adverse events leading to discontinuation of medicine was observed.
CONCLUSIONS
CONCLUSIONS
The combination of sofosbuvir and daclatasvir is an effective and safe treatment for patients infected with all genotypes of hepatitis C who have severe renal impairment, including patients on hemodialysis.
Substances chimiques
Antiviral Agents
0
Carbamates
0
Imidazoles
0
Pyrrolidines
0
Valine
HG18B9YRS7
daclatasvir
LI2427F9CI
Sofosbuvir
WJ6CA3ZU8B
Banques de données
ClinicalTrials.gov
['NCT03063879']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1590-1594Subventions
Organisme : Digestive Disease Research Institute at Tehran University of Medical Sciences
Informations de copyright
© 2020 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.
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