Safety and efficacy of glecaprevir and pibrentasvir in Japanese hemodialysis patients with genotype 2 hepatitis C virus infection
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 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 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 An 8- or 12-week G/P regimen is highly effective and safe in GT2 HCV-infected hemodialysis patients..
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:54 |
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| Enthalten in: |
Journal of gastroenterology - 54(2019), 7 vom: 18. Feb., Seite 641-649 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Suda, Goki [VerfasserIn] |
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| Links: |
Volltext [lizenzpflichtig] |
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| Themen: |
| doi: |
10.1007/s00535-019-01556-y |
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SPR006777317 |
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| 520 | |a 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 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 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 An 8- or 12-week G/P regimen is highly effective and safe in GT2 HCV-infected hemodialysis patients. | ||
| 650 | 4 | |a HCV |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Hemodialysis |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Genotype 2 |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Glecaprevir |7 (dpeaa)DE-He213 | |
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| 700 | 1 | |a Hasebe, Chitomi |e verfasserin |4 aut | |
| 700 | 1 | |a Abe, Masami |e verfasserin |4 aut | |
| 700 | 1 | |a Kurosaki, Masayuki |e verfasserin |4 aut | |
| 700 | 1 | |a Itakura, Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Izumi, Namiki |e verfasserin |4 aut | |
| 700 | 1 | |a Uchida, Yoshihito |e verfasserin |4 aut | |
| 700 | 1 | |a Mochida, Satoshi |e verfasserin |4 aut | |
| 700 | 1 | |a Haga, Hiroaki |e verfasserin |4 aut | |
| 700 | 1 | |a Ueno, Yoshiyuki |e verfasserin |4 aut | |
| 700 | 1 | |a Abe, Kazumichi |e verfasserin |4 aut | |
| 700 | 1 | |a Takahashi, Atsushi |e verfasserin |4 aut | |
| 700 | 1 | |a Ohira, Hiromasa |e verfasserin |4 aut | |
| 700 | 1 | |a Tsukuda, Yoko |e verfasserin |4 aut | |
| 700 | 1 | |a Furuya, Ken |e verfasserin |4 aut | |
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| 700 | 1 | |a Ohara, Masatsugu |e verfasserin |4 aut | |
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| 700 | 1 | |a Izumi, Takaaki |e verfasserin |4 aut | |
| 700 | 1 | |a Nakai, Masato |e verfasserin |4 aut | |
| 700 | 1 | |a Sho, Takuya |e verfasserin |4 aut | |
| 700 | 1 | |a Natsuizaka, Mitsuteru |e verfasserin |4 aut | |
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| 700 | 1 | |a Ogawa, Koji |e verfasserin |4 aut | |
| 700 | 1 | |a Sakamoto, Naoya |e verfasserin |4 aut | |
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