Safety and efficacy of elbasvir and grazoprevir in Japanese hemodialysis patients with genotype 1b hepatitis C virus infection
Safety and efficacy of elbasvir and grazoprevir in Japanese hemodialysis patients with genotype 1b hepatitis C virus infection
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DOI：
10.1007/s00535-018-1495-6
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发表时间：
2019-01-01
影响因子：
6.3
通讯作者：
Ymamoto, Yoshiya
中科院分区：
文献类型：
--
作者：
Suda, Goki;Kurosaki, Masayuki;Ymamoto, Yoshiya
背景：丙型肝炎病毒在血液透析患者中的感染率较高，预后不良。因此，需要更安全、更有效的治疗方案。在这项前瞻性的多中心研究中，我们研究了新型丙型肝炎病毒NS5A抑制剂艾尔巴韦尔和蛋白酶抑制剂格拉佐维韦对感染1b型丙型肝炎病毒的日本血液透析患者的疗效和安全性。纳入2017年1月至2018年3月期间接受艾尔巴韦和格拉佐韦治疗并在治疗完成后随访超过12周的23名感染1b型丙型肝炎的日本透析患者。结果23例患者中，7例为晚期肝纤维化，2例为NS5A(NS5A RAVS)的标志性耐药变异--基线时为L31M/V或Y93H。所有患者均完成治疗，96.7%(22/23)的患者达到了SVR12。所有晚期肝纤维化患者和基线签名的NS5A RAV患者都获得了高安全性的SVR12。没有患者在治疗期间经历致命或严重的不良事件，最常见的不良事件是贫血。1例对此治疗无反应的患者，有达拉塔韦和阿司那韦治疗失败的病史，基线时有A92K的NS5A RAV，但没有标志性的NS5A RAV。结论Grazopvir和Elbasvir联合治疗1b型丙型肝炎病毒感染的血液透析患者是高效和安全的。
BackgroundThe 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.MethodsThis 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 12weeks after treatment completion were included. We evaluated the sustained virologic response at 12weeks after treatment completion (SVR12) and safety during treatment.ResultsOf 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.ConclusionsGrazoprevir and elbasvir combination is highly effective and safe for hemodialysis patients with genotype 1b HCV infection.