Goki Suda1, Masayuki Kurosaki2, Jun Itakura2, Namiki Izumi2, Yoshihito Uchida3, Satoshi Mochida3, Chitomi Hasebe4, Masami Abe4, Hiroaki Haga5, Yoshiyuki Ueno5, Ikuto Masakane6, Kazumichi Abe7, Atsushi Takahashi7, Hiromasa Ohira7, Ken Furuya8, Masaru Baba8, Yoshiya Yamamoto9, Tomoe Kobayashi10, Atsuhiko Kawakami11, Kenichi Kumagai12, Katsumi Terasita1, Masatsugu Ohara1, Naoki Kawagishi1, Machiko Umemura1, Masato Nakai1, Takuya Sho1, Mitsuteru Natsuizaka1, Kenichi Morikawa1, Koji Ogawa1, Naoya Sakamoto13. 1. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan. 2. Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Musashino, Tokyo, Japan. 3. Department of Gastroenterology and Hepatology, Faculty of Medicine, Saitama Medical University, Saitama, Japan. 4. Department of Gastroenterology, Japanese Red Cross Asahikawa Hospital, Asahikawa, Japan. 5. Department of Gastroenterology, Faculty of Medicine, Yamagata University, Yamagata, Japan. 6. Yabuki Hospital, Yamagata, Japan. 7. Department of Gastroenterology, Fukushima Medical University School of Medicine, Fukushima, Japan. 8. Department of Gastroenterology and Hepatology, Japan Community Health Care Organization (JCHO) Hokkaido Hospital, Sapporo, Hokkaido, Japan. 9. Hakodate City Hospital, Hakodate, Hokkaido, Japan. 10. Tomakomai City Hospital, Tomakomai, Hokkaido, Japan. 11. Century Hospital, Sapporo, Hokkaido, Japan. 12. Mori City National Health Insurance Hospital, Mori, Hokkaido, Japan. 13. Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan. sakamoto@med.hokudai.ac.jp.
Abstract
BACKGROUND: The prevalence of hepatitis C virus (HCV) infection in hemodialysis patients is high and results in a poor prognosis. Thus, safer and more effective treatment regimens are required. In this prospective multicenter study, we investigated the efficacy and safety of the novel HCV-NS5A-inhibitor, elbasvir, and protease inhibitor, grazoprevir in Japanese hemodialysis patients with genotype 1b HCV infection. METHODS: This study is registered at the UMIN Clinical Trials Registry as UMIN00002578. A total of 23 Japanese dialysis patients with genotype 1b HCV infection who were treated with elbasvir and grazoprevir between January 2017 and March 2018 and followed for more than 12 weeks after treatment completion were included. We evaluated the sustained virologic response at 12 weeks after treatment completion (SVR12) and safety during treatment. RESULTS: Of the 23 patients, 7 had advanced liver fibrosis and 2 had a signature resistance-associated variant of NS5A (NS5A RAVs)-L31M/V or Y93H at baseline. All patients completed therapy, and 96.7% (22/23) of the patients achieved SVR12. All patients with advanced liver fibrosis and signature NS5A RAVs at baseline achieved SVR12 with a high safety profile. No patient experienced lethal or severe adverse events during therapy, and the most common adverse event was anemia. One patient, who was a non-responder to this therapy, had a history of failure with daclatasvir and asunaprevir therapies and had NS5A RAVs of A92K at baseline, but not signature NS5A RAVs. CONCLUSIONS: Grazoprevir and elbasvir combination is highly effective and safe for hemodialysis patients with genotype 1b HCV infection.
BACKGROUND: The prevalence of hepatitis C virus (HCV) infection in hemodialysis patients is high and results in a poor prognosis. Thus, safer and more effective treatment regimens are required. In this prospective multicenter study, we investigated the efficacy and safety of the novel HCV-NS5A-inhibitor, elbasvir, and protease inhibitor, grazoprevir in Japanese hemodialysis patients with genotype 1b HCV infection. METHODS: This study is registered at the UMIN Clinical Trials Registry as UMIN00002578. A total of 23 Japanese dialysis patients with genotype 1b HCV infection who were treated with elbasvir and grazoprevir between January 2017 and March 2018 and followed for more than 12 weeks after treatment completion were included. We evaluated the sustained virologic response at 12 weeks after treatment completion (SVR12) and safety during treatment. RESULTS: Of the 23 patients, 7 had advanced liver fibrosis and 2 had a signature resistance-associated variant of NS5A (NS5A RAVs)-L31M/V or Y93H at baseline. All patients completed therapy, and 96.7% (22/23) of the patients achieved SVR12. All patients with advanced liver fibrosis and signature NS5A RAVs at baseline achieved SVR12 with a high safety profile. No patient experienced lethal or severe adverse events during therapy, and the most common adverse event was anemia. One patient, who was a non-responder to this therapy, had a history of failure with daclatasvir and asunaprevir therapies and had NS5A RAVs of A92K at baseline, but not signature NS5A RAVs. CONCLUSIONS: Grazoprevir and elbasvir combination is highly effective and safe for hemodialysis patients with genotype 1b HCV infection.
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
Authors: David Wyles; Hadas Dvory-Sobol; Evguenia S Svarovskaia; Brian P Doehle; Ross Martin; Nezam H Afdhal; Kris V Kowdley; Eric Lawitz; Diana M Brainard; Michael D Miller; Hongmei Mo; Edward J Gane Journal: J Hepatol Date: 2016-12-05 Impact factor: 25.083
Authors: Elise J Smolders; Anouk M E Jansen; Peter G J Ter Horst; Jürgen Rockstroh; David J Back; David M Burger Journal: Clin Pharmacokinet Date: 2019-10 Impact factor: 6.447