Goki Suda1, Chitomi Hasebe2, Masami Abe2, Masayuki Kurosaki3, Jun Itakura3, Namiki Izumi3, Yoshihito Uchida4, Satoshi Mochida4, Hiroaki Haga5, Yoshiyuki Ueno5, Kazumichi Abe6, Atsushi Takahashi6, Hiromasa Ohira6, Yoko Tsukuda7, Ken Furuya8, Masaru Baba8, Yoshiya Yamamoto9, Tomoe Kobayashi10, Jun Inoue11, Katsumi Terasita1, Masatsugu Ohara1, Naoki Kawagishi1, Takaaki Izumi1, Masato Nakai1, Takuya Sho1, Mitsuteru Natsuizaka1, Kenichi Morikawa1, Koji Ogawa1, Naoya Sakamoto12. 1. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, 060-8638, Hokkaido, Japan. 2. Department of Gastroenterology, Japanese Red Cross Asahikawa Hospital, Asahikawa, Japan. 3. Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Tokyo, Japan. 4. Department of Gastroenterology and Hepatology, Faculty of Medicine, Saitama Medical University, Saitama, Japan. 5. Department of Gastroenterology, Faculty of Medicine, Yamagata University, Yamagata, Japan. 6. Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, Japan. 7. Sapporo City General Hospital, Hokkaido, Japan. 8. Department of Gastroenterology and Hepatology, Japan Community Health Care Organization (JCHO) Hokkaido Hospital, Hokkaido, Japan. 9. Hakodate City Hospital, Hokkaido, Japan. 10. Tomakomai City Hospital, Hokkaido, Japan. 11. Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan. 12. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, 060-8638, Hokkaido, Japan. sakamoto@med.hokudai.ac.jp.
Abstract
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.
BACKGROUND: Until recently, interferon-free anti-hepatitis C virus (HCV) therapy for genotype 2 (GT2) HCV-infected hemodialysispatients 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-infectedpatients, 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 hemodialysispatients.
Authors: Ronald L Pisoni; Björn Wikström; Stacey J Elder; Tadao Akizawa; Yashushi Asano; Marcia L Keen; Rajiv Saran; David C Mendelssohn; Eric W Young; Friedrich K Port Journal: Nephrol Dial Transplant Date: 2006-09-12 Impact factor: 5.992
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Authors: David A Goodkin; Jennifer L Bragg-Gresham; Karl G Koenig; Robert A Wolfe; Takashi Akiba; Vittorio E Andreucci; Akira Saito; Hugh C Rayner; Kiyoshi Kurokawa; Friedrich K Port; Philip J Held; Eric W Young Journal: J Am Soc Nephrol Date: 2003-12 Impact factor: 10.121
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