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      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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          Abstract

          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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          Author and article information

          Journal
          BPU
          Blood Purif
          10.1159/issn.0253-5068
          Blood Purification
          S. Karger AG
          0253-5068
          1421-9735
          2020
          November 2020
          14 April 2020
          : 49
          : 6
          : 692-699
          Affiliations
          aDepartment of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China
          bGuangdong Provincial People’s Hospital Medical Research Center, Guangdong Cardiovascular Institute, Guangdong Academy of Medical Sciences, Guangzhou, China
          cDepartment of the Severe Liver Disease, Guangzhou 8th General Hospital, Guangzhou, China
          Author notes
          *Xinling Liang and Shuangxin Liu, Department of Nephrology, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Science, Guangzhou 510080 (PR China), E-Mail xinlingliang_ggh@163.com and 13543456446@163.com
          Article
          499161 Blood Purif 2020;49:692–699
          10.1159/000499161
          32289799
          © 2020 S. Karger AG, Basel

          Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

          Page count
          Figures: 1, Tables: 4, Pages: 8
          Categories
          Research Article

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