来迪派韦索磷布韦治疗伴中度肾功能损害的 1b 型慢性丙型肝炎病毒感染患者的疗效和安全性。
Efficacy and safety of ledipasvir/sofosbuvir for genotype 1b chronic hepatitis C patients with moderate renal impairment.
机构信息
Division of Gastroenterology, Department of Internal Medicine, Nippon Medical School Chiba Hokusoh Hospital, 1715 Kamagari, Inzai, Chiba, 270-1694, Japan.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan.
出版信息
Hepatol Int. 2018 Mar;12(2):133-142. doi: 10.1007/s12072-018-9859-9. Epub 2018 Mar 29.
BACKGROUND/AIM: To evaluate the efficacy and safety of ledipasvir and sofosbuvir therapy for genotype 1b in chronic hepatitis C patients with chronic kidney disease (CKD) stage 3.
METHODS
In a multicenter collaborative retrospective study, 706 patients who have received ledipasvir which is NS5A inhibitor, and sofosbuvir 400 mg which is NS5B nucleoside polymerase inhibitor daily for 12 weeks between September 2015 and January 2017 were subjected to this analysis. Virologic response and adverse events in patients with CKD stage 3 were compared with those in patients with CKD stages 1 and 2.
RESULTS
The rates of sustained virologic response (SVR) were 97.0% in patients with CKD stage 1, 97.1% in patients with CKD stage 2, and 94.7% in patients with CKD stage 3, respectively. There were no significant differences in the SVR rates between CKD stages 1 and 2, and CKD stage 1 and stage 3. The incidence of adverse events over than grade 2 was 0% in patients with CKD stage 1, 0.5% in patients with CKD stage 2, and 3.0% in patients with CKD stage 3, respectively. For treatment and follow-up period, eGFR levels in the patients with CKD stage 3 were not worsened compared to those at baseline.
CONCLUSION
This study suggested that the virologic response of ledipasvir and sofosbuvir in patients with CKD stage 3 was not inferior to those with CKD stages 1 and 2. In addition, administration of ledipasvir and sofosbuvir did not affect eGFR levels in the patients with CKD stage 3.
背景/目的：评估索磷布韦联合利迪帕韦治疗慢性丙型肝炎 1b 基因型合并慢性肾脏病（CKD）3 期患者的疗效和安全性。
方法
采用多中心合作回顾性研究，对 2015 年 9 月至 2017 年 1 月期间接受每日利迪帕韦（一种 NS5A 抑制剂）和索磷布韦（一种 NS5B 核苷酸聚合酶抑制剂）400mg 治疗 12 周的 706 例患者进行了此项分析。比较了 CKD 3 期患者与 CKD 1 期和 2 期患者的病毒学应答和不良反应。
结果
CKD 1 期、2 期和 3 期患者的持续病毒学应答（SVR）率分别为 97.0%、97.1%和 94.7%。CKD 1 期和 2 期患者、CKD 1 期和 3 期患者的 SVR 率无显著差异。CKD 1 期、2 期和 3 期患者不良反应发生率大于 2 级者分别为 0%、0.5%和 3.0%。在治疗和随访期间，CKD 3 期患者的 eGFR 水平与基线相比没有恶化。
结论
本研究表明，索磷布韦联合利迪帕韦治疗 CKD 3 期患者的病毒学应答不劣于 CKD 1 期和 2 期患者。此外，给予 CKD 3 期患者利迪帕韦和索磷布韦治疗不会影响 eGFR 水平。
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