Department of Gastroenterology and Hepatology, Graduate School of Medicine, Hokkaido University, North 15, West 7, Kita-ku, Sapporo, 060-8638, Hokkaido, Japan.
Department of Gastroenterology, Japanese Red Cross Asahikawa Hospital, Asahikawa, Japan.
J Gastroenterol. 2019 Jul;54(7):641-649. doi: 10.1007/s00535-019-01556-y. Epub 2019 Feb 18.
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.
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.
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.
An 8- or 12-week G/P regimen is highly effective and safe in GT2 HCV-infected hemodialysis patients.
直到最近，针对基因型 2（GT2）丙型肝炎病毒（HCV）感染血液透析患者的无干扰素抗 HCV 治疗仍是未满足的医疗需求。最近针对血液透析患者的 glecaprevir 和 pibrentasvir（G/P）的临床试验显示了其高效性和安全性；然而，GT2 HCV 感染患者，尤其是亚洲患者的数量有限，且大多数患者接受的是 12 周的疗程。在这项前瞻性多中心研究中，我们旨在研究 G/P 在日本 GT2 HCV 感染血液透析患者中的疗效和安全性。
2017 年 11 月至 2018 年 6 月期间，27 例 GT2 HCV 感染的日本血液透析患者开始接受 8 或 12 周的 G/P 治疗方案，并在治疗结束后随访约 12 周。
27 例纳入患者中，13 例非肝硬化（LC）且无直接作用抗病毒药物（DAA）治疗史的患者接受 8 周 G/P 治疗，14 例 LC（n=13）或 DAA 治疗失败史（n=1）的患者接受 12 周的治疗方案。治疗结束后 12 周的总体持续病毒学应答（SVR12）为 96.3%（26/27）。所有接受 8 周治疗的患者均达到 SVR12。有 2 例患者分别在治疗开始后 2 周和 11 周停止治疗。因瘙痒单独停药的患者未对 G/P 产生应答。在治疗期间，没有患者发生致命的不良事件，最常见的不良事件是瘙痒。
8 或 12 周的 G/P 方案对 GT2 HCV 感染血液透析患者具有高效性和安全性。
