Safety and efficacy of glecaprevir and pibrentasvir in Japanese hemodialysis patients with genotype 2 hepatitis C virus infection.
Aged
Antiviral Agents
/ adverse effects
Benzimidazoles
/ adverse effects
Drug Combinations
Female
Genotype
Hepacivirus
/ genetics
Hepatitis C, Chronic
/ drug therapy
Humans
Japan
Liver Cirrhosis
/ drug therapy
Male
Middle Aged
Prospective Studies
Pyrrolidines
/ adverse effects
Quinoxalines
/ adverse effects
Renal Dialysis
Sulfonamides
/ adverse effects
Sustained Virologic Response
Treatment Outcome
Genotype 2
Glecaprevir
HCV
Hemodialysis
Pibrentasvir
Journal
Journal of gastroenterology
ISSN: 1435-5922
Titre abrégé: J Gastroenterol
Pays: Japan
ID NLM: 9430794
Informations de publication
Date de publication:
Jul 2019
Jul 2019
Historique:
received:
13
11
2018
accepted:
04
02
2019
pubmed:
20
2
2019
medline:
20
6
2020
entrez:
20
2
2019
Statut:
ppublish
Résumé
Until recently, interferon-free anti-hepatitis C virus (HCV) therapy for genotype 2 (GT2) HCV-infected hemodialysis patients was an unfulfilled medical need. Recent clinical trials of glecaprevir and pibrentasvir (G/P) for hemodialysis patients showed high efficacy and safety; however, the number of GT2 HCV-infected patients, especially Asian patients, was limited and most of them were treated with a 12-week regimen. In this prospective multicenter study, we aimed to investigate the efficacy and safety of G/P in Japanese hemodialysis patients with GT2 HCV infection. Twenty-seven Japanese hemodialysis patients with GT2 HCV infection who were started on with 8- or 12-week G/P regimen between November 2017 and June 2018 were included and followed up for around 12 weeks after treatment completion. Among the 27 included patients, 13 non-liver cirrhosis (LC) and direct-acting antivirals (DAAs)-naïve patients were treated with 8 weeks of G/P and 14 patients with LC (n = 13) or history of failure of DAAs (n = 1) were treated with a 12-week regimen. The overall sustained virological response at 12 weeks after treatment completion (SVR 12) was 96.3% (26/27). All patients with 8 weeks of treatment achieved SVR12. Two patients discontinued the therapy at 2 and 11 weeks after treatment initiation. The patient who discontinued at 2 weeks due to pruritus alone failed to respond to G/P. No patients experienced lethal adverse events during the therapy, and the most common adverse event was pruritus. An 8- or 12-week G/P regimen is highly effective and safe in GT2 HCV-infected hemodialysis patients.
Sections du résumé
BACKGROUND
BACKGROUND
Until recently, interferon-free anti-hepatitis C virus (HCV) therapy for genotype 2 (GT2) HCV-infected hemodialysis patients was an unfulfilled medical need. Recent clinical trials of glecaprevir and pibrentasvir (G/P) for hemodialysis patients showed high efficacy and safety; however, the number of GT2 HCV-infected patients, especially Asian patients, was limited and most of them were treated with a 12-week regimen. In this prospective multicenter study, we aimed to investigate the efficacy and safety of G/P in Japanese hemodialysis patients with GT2 HCV infection.
METHODS
METHODS
Twenty-seven Japanese hemodialysis patients with GT2 HCV infection who were started on with 8- or 12-week G/P regimen between November 2017 and June 2018 were included and followed up for around 12 weeks after treatment completion.
RESULTS
RESULTS
Among the 27 included patients, 13 non-liver cirrhosis (LC) and direct-acting antivirals (DAAs)-naïve patients were treated with 8 weeks of G/P and 14 patients with LC (n = 13) or history of failure of DAAs (n = 1) were treated with a 12-week regimen. The overall sustained virological response at 12 weeks after treatment completion (SVR 12) was 96.3% (26/27). All patients with 8 weeks of treatment achieved SVR12. Two patients discontinued the therapy at 2 and 11 weeks after treatment initiation. The patient who discontinued at 2 weeks due to pruritus alone failed to respond to G/P. No patients experienced lethal adverse events during the therapy, and the most common adverse event was pruritus.
CONCLUSIONS
CONCLUSIONS
An 8- or 12-week G/P regimen is highly effective and safe in GT2 HCV-infected hemodialysis patients.
Identifiants
pubmed: 30778716
doi: 10.1007/s00535-019-01556-y
pii: 10.1007/s00535-019-01556-y
doi:
Substances chimiques
Antiviral Agents
0
Benzimidazoles
0
Drug Combinations
0
Pyrrolidines
0
Quinoxalines
0
Sulfonamides
0
glecaprevir and pibrentasvir
0
Types de publication
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
641-649Subventions
Organisme : AMED
ID : 18fk0210002h0003
Organisme : AMED
ID : JP18fk0210018h0002
Organisme : KAKEN
ID : 16K09334
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