1. Safety and efficacy of glecaprevir and pibrentasvir in Japanese hemodialysis patients with genotype 2 hepatitis C virus infection.
- Author
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Suda G, Hasebe C, Abe M, Kurosaki M, Itakura J, Izumi N, Uchida Y, Mochida S, Haga H, Ueno Y, Abe K, Takahashi A, Ohira H, Tsukuda Y, Furuya K, Baba M, Yamamoto Y, Kobayashi T, Inoue J, Terasita K, Ohara M, Kawagishi N, Izumi T, Nakai M, Sho T, Natsuizaka M, Morikawa K, Ogawa K, and Sakamoto N
- Subjects
- Aged, Antiviral Agents adverse effects, Benzimidazoles adverse effects, Drug Combinations, Female, Genotype, Hepacivirus genetics, Humans, Japan, Liver Cirrhosis drug therapy, Liver Cirrhosis pathology, Male, Middle Aged, Prospective Studies, Pyrrolidines adverse effects, Quinoxalines adverse effects, Sulfonamides adverse effects, Sustained Virologic Response, Treatment Outcome, Antiviral Agents therapeutic use, Benzimidazoles therapeutic use, Hepatitis C, Chronic drug therapy, Pyrrolidines therapeutic use, Quinoxalines therapeutic use, Renal Dialysis, Sulfonamides therapeutic use
- 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.
- Published
- 2019
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