Elbasvir/grazoprevir 治疗合并慢性肾脏病（包括透析患者）的 1b 型慢性丙型肝炎日本患者的疗效和安全性：一项多中心研究的事后分析。
Efficacy and safety of elbasvir/grazoprevir for Japanese patients with genotype 1b chronic hepatitis C complicated by chronic kidney disease, including those undergoing hemodialysis: A post hoc analysis of a multicenter study.
机构信息
Department of Internal Medicine, Division of Gastroenterology and Hepatology, Nippon Medical School, Tokyo, Japan.
The Core Research Facilities for Basic Science, The Jikei University School of Medicine, Tokyo, Japan.
出版信息
J Gastroenterol Hepatol. 2019 Feb;34(2):364-369. doi: 10.1111/jgh.14447. Epub 2018 Sep 14.
BACKGROUND AND AIM
This study aimed to evaluate the efficacy and safety of elbasvir/grazoprevir in genotype 1b chronic hepatitis C Japanese patients with chronic kidney disease (CKD), including those undergoing hemodialysis.
METHODS
This post hoc analysis of a multicenter, retrospective study included patients who had received elbasvir/grazoprevir. CKD was defined by an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m . The sustained virologic response (SVR) rate and frequency of treatment-emergent adverse events were assessed in patients with CKD.
RESULTS
The study population comprised 155 men and 182 women. The median eGFR level at baseline was 69.6 mL/min/1.73 m (range, 3.0-128.5 mL/min/1.73 m ). Among the 337 patients, 109 (32.3%) had CKD: 72, 14, and 23 (including 20 hemodialysis) had CKD stages 3, 4, and 5, respectively. The SVR rates according to the baseline CKD stages were 98.1% (51/52) in stage 1, 98.3% (173/176) in stage 2, 93.9% (46/49) in stage 3a, 100% (23/23) in stage 3b, 100% (14/14) in stage 4, and 100% (23/23) in stage 5. All 20 patients undergoing hemodialysis achieved SVR. There was no significant decrease from baseline in the median eGFR level throughout the treatment period among the patients with CKD. The incidence of treatment-emergent adverse events was 6.4% (7/109) among the patients with CKD and 9.7% (22/228) among the patients without CKD (not significant, P = 0.323).
CONCLUSIONS
The present study demonstrated that elbasvir and grazoprevir are highly effective and safe for genotype 1b chronic hepatitis C Japanese patients with CKD, including those undergoing hemodialysis.
背景和目的
本研究旨在评估 Elbasvir/Grazoprevir 在慢性丙型肝炎基因型 1b 的日本伴有慢性肾脏病（CKD）患者中的疗效和安全性，包括接受血液透析的患者。
方法
这是一项多中心、回顾性研究的事后分析，纳入了接受 Elbasvir/Grazoprevir 治疗的患者。CKD 的定义为估算肾小球滤过率（eGFR）<60 mL/min/1.73 m 。评估了 CKD 患者的持续病毒学应答（SVR）率和治疗中出现的不良事件的发生频率。
结果
研究人群包括 155 名男性和 182 名女性。基线时的中位 eGFR 水平为 69.6 mL/min/1.73 m（范围 3.0-128.5 mL/min/1.73 m ）。在 337 名患者中，有 109 名（32.3%）患有 CKD：72 名、14 名和 23 名（包括 20 名血液透析）分别患有 CKD 3 期、4 期和 5 期。根据基线 CKD 分期，SVR 率分别为：1 期 98.1%（51/52），2 期 98.3%（173/176），3a 期 93.9%（46/49），3b 期 100%（23/23），4 期 100%（14/14），5 期 100%（23/23）。所有 20 名接受血液透析的患者均达到 SVR。在整个治疗期间，CKD 患者的中位 eGFR 水平从基线开始没有明显下降。CKD 患者中治疗中出现的不良事件发生率为 6.4%（7/109），无 CKD 患者中为 9.7%（22/228）（无显著差异，P=0.323）。
结论
本研究表明，Elbasvir 和 Grazoprevir 对慢性丙型肝炎基因型 1b 的日本伴有 CKD 的患者，包括接受血液透析的患者，具有高度有效性和安全性。
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