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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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          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

          Blood Purif
          Blood Purification
          S. Karger AG
          November 2020
          14 April 2020
          : 49
          : 6
          : 692-699
          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 and
          499161 Blood Purif 2020;49:692–699
          © 2020 S. Karger AG, Basel

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


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