终末期肾病患者中与达卡他韦或来迪派韦联合使用的索磷布韦复方制剂的疗效和药代动力学受血液透析的影响。
Effect of Hemodialysis on Efficacy and Pharmacokinetics of Sofosbuvir Coformulated with Either Daclatasvir or Ledipasvir in Patients with End-Stage Renal Disease.
机构信息
Department of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Guangdong Provincial People's Hospital Medical Research Center, Guangdong Cardiovascular Institute, Guangdong Academy of Medical Sciences, Guangzhou, China.
出版信息
Blood Purif. 2020;49(6):692-699. doi: 10.1159/000499161. Epub 2020 Apr 14.
BACKGROUND/AIMS: Direct-acting antivirals (DAAs) play a key role in the eradication of hepatitis C virus (HCV) infection. However, limited data are available on DAA for treating HCV infection in hemodialysis (HD) patients. This study was to evaluate the pharmacokinetic characteristics and effectiveness of daclatasvir/sofosbuvir (DAC/SOF) and ledipasvir/SOF (LDV/SOF) in HD patients.
METHODS
Seven patients were given SOF coadministered with DAC or LDV once daily for 12 weeks. The plasma concentrations of SOF007, DAC, and LDV were determined by high-performance liquid chromatography-electrospray ionization tandem mass spectrometry.
RESULTS
A sustained virologic response in week 12 (SVR12) was achieved in 6 (100%) patients, except for 1 patient dying due to severe cerebral hemorrhage not related to antiviral therapy. The extraction ratio of SOF007 was 66.67%, and the estimated HD clearance of SOF007 was 5.65 L/h.
CONCLUSION
The combination of SOF with either DAC or LDV is well tolerated and offers high SVR12 in HD patients.
背景/目的：直接作用抗病毒药物（DAAs）在消除丙型肝炎病毒（HCV）感染方面发挥着关键作用。然而，关于 DAA 治疗血液透析（HD）患者 HCV 感染的数据有限。本研究旨在评估达卡他韦/索磷布韦（DAC/SOF）和来迪派韦/索磷布韦（LDV/SOF）在 HD 患者中的药代动力学特征和疗效。
方法
7 名患者每日一次给予 SOF 联合 DAC 或 LDV 治疗 12 周。采用高效液相色谱-电喷雾串联质谱法测定 SOF007、DAC 和 LDV 的血浆浓度。
结果
6 名（100%）患者获得了第 12 周持续病毒学应答（SVR12），除了 1 名因与抗病毒治疗无关的严重脑出血死亡的患者。SOF007 的提取率为 66.67%，估计 SOF007 的 HD 清除率为 5.65 L/h。
结论
SOF 联合 DAC 或 LDV 治疗具有良好的耐受性，并可在 HD 患者中获得高 SVR12。
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