Safety and efficacy of elbasvir and grazoprevir in Japanese hemodialysis patients with genotype 1b hepatitis C virus infection.

Journal of Gastroenterology
Goki SudaNORTE Study Group

Abstract

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. 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. 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...Continue Reading

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Citations

May 23, 2019·Clinical Pharmacokinetics·Elise J SmoldersDavid M Burger
Feb 6, 2020·Hepatology Research : the Official Journal of the Japan Society of Hepatology·Naoki KawagishiNaoya Sakamoto
Jul 16, 2020·Journal of Gastroenterology and Hepatology·Goki Suda, Naoya Sakamoto
Mar 12, 2021·Journal of Nippon Medical School = Nippon Ika Daigaku Zasshi·Masanori AtsukawaKatsuhiko Iwakiri

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