Effect of Hemodialysis on Efficacy and Pharmacokinetics of Sofosbuvir Coformulated with Either Daclatasvir or Ledipasvir in Patients with End-Stage Renal Disease

Effect of Hemodialysis on Efficacy and Pharmacokinetics of Sofosbuvir Coformulated with Either Daclatasvir or Ledipasvir in Patients with End-Stage Renal Disease
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血液透析对索磷布韦联合达卡他韦或雷迪帕韦治疗终末期肾病患者疗效和药代动力学的影响

DOI:
10.1159/000499161
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发表时间:
2020-04
期刊:
影响因子:
3
通讯作者:
Shuangxin Liu
Shuangxin Liu
中科院分区:
医学4区
文献类型:
--
作者:
Ting Lin;Xipei Wang;Hongbo Gao;Zhonglin Feng;Lixia Xu;Jianchao Ma;Zhuo Li;Li Zhang;Renwei Huang;Xinling Liang;Shuangxin Liu

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背景/目的:直接作用抗病毒药物(DAA)在根除丙型肝炎病毒(HCV)感染中发挥关键作用。然而,关于DAA治疗血液透析(HD)患者HCV感染的数据有限。本研究旨在评价达卡他韦/索非布韦(DAC/SOF)和雷迪帕韦/SOF(LDV/SOF)在HD患者中的药代动力学特征和有效性。方法:7例患者接受SOF联合DAC或LDV治疗,每日1次,共12周。采用高效液相色谱-电喷雾串联质谱法测定SOF 007、DAC和LDV的血浆浓度。结果如下:除1例患者死于与抗病毒治疗无关的严重脑出血外,6例(100%)患者在第12周达到持续病毒学应答(SVR 12)。SOF 007的提取率为66.67%,SOF 007的估计HD清除率为5.65 L/h。结论:SOF联合DAC或LDV在HD患者中耐受性良好,并提供高SVR 12。
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.
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发表时间: 2001-07
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