Safety and efficacy of glecaprevir and pibrentasvir in Japanese hemodialysis patients with genotype 2 hepatitis C virus infection

Abstract

BackgroundUntil 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.MethodsTwenty-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\xa0weeks after treatment completion.ResultsAmong the 27 included patients, 13 non-liver cirrhosis (LC) and direct-acting antivirals (DAAs)-naïve patients were treated with 8\xa0weeks of G/P and 14 patients with LC (n\u2009=\u200913) or history of failure of DAAs (n\u2009=\u20091) were treated with a 12-week regimen. The overall sustained virological response at 12\xa0weeks after treatment completion (SVR 12) was 96.3% (26/27). All patients with 8\xa0weeks of treatment achieved SVR12. Two patients discontinued the therapy at 2 and 11\xa0weeks after treatment initiation. The patient who discontinued at 2\xa0weeks 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.ConclusionsAn 8- or 12-week G/P regimen is highly effective and safe in GT2 HCV-infected hemodialysis patients.