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No Pharmacokinetic Interaction Between the Hepatitis C Virus Inhibitors Elbasvir/Grazoprevir and Famotidine or Pantoprazole

Use of agents to suppress gastric acid secretion is common among patients with hepatitis C virus (HCV) infection. The aims of this open‐label, three‐period, fixed‐sequence study were to evaluate the effect of famotidine and pantoprazole on the pharmacokinetics and safety of elbasvir/grazoprevir fixe...

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Autores principales: Feng, H‐P, Vaddady, P, Guo, Z, Liu, F, Panebianco, D, Levine, V, Caro, L, Butterton, JR, Iwamoto, M, Yeh, WW
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5593162/
https://www.ncbi.nlm.nih.gov/pubmed/28625018
http://dx.doi.org/10.1111/cts.12465
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author Feng, H‐P
Vaddady, P
Guo, Z
Liu, F
Panebianco, D
Levine, V
Caro, L
Butterton, JR
Iwamoto, M
Yeh, WW
author_facet Feng, H‐P
Vaddady, P
Guo, Z
Liu, F
Panebianco, D
Levine, V
Caro, L
Butterton, JR
Iwamoto, M
Yeh, WW
author_sort Feng, H‐P
collection PubMed
description Use of agents to suppress gastric acid secretion is common among patients with hepatitis C virus (HCV) infection. The aims of this open‐label, three‐period, fixed‐sequence study were to evaluate the effect of famotidine and pantoprazole on the pharmacokinetics and safety of elbasvir/grazoprevir fixed‐dose combination (FDC) in 16 healthy subjects. Elbasvir and grazoprevir each exhibited similar pharmacokinetics following single‐dose administration of elbasvir/grazoprevir with or without famotidine or pantoprazole. Geometric mean ratios (GMRs) of grazoprevir AUC(0,∞), C(max), and C(24) (elbasvir/grazoprevir + famotidine or elbasvir/grazoprevir + pantoprazole vs. elbasvir/grazoprevir) ranged from 0.89–1.17. Similarly, GMRs of elbasvir AUC(0,∞), C(max), and C(24) (elbasvir/grazoprevir + famotidine or elbasvir/grazoprevir + pantoprazole vs. elbasvir/grazoprevir) ranged from 1.02–1.11. These results indicate that gastric acid‐reducing agents do not modify the pharmacokinetics of elbasvir or grazoprevir in a clinically relevant manner and may be coadministered with elbasvir/grazoprevir in HCV‐infected patients without restriction.
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spelling pubmed-55931622017-09-13 No Pharmacokinetic Interaction Between the Hepatitis C Virus Inhibitors Elbasvir/Grazoprevir and Famotidine or Pantoprazole Feng, H‐P Vaddady, P Guo, Z Liu, F Panebianco, D Levine, V Caro, L Butterton, JR Iwamoto, M Yeh, WW Clin Transl Sci Research Use of agents to suppress gastric acid secretion is common among patients with hepatitis C virus (HCV) infection. The aims of this open‐label, three‐period, fixed‐sequence study were to evaluate the effect of famotidine and pantoprazole on the pharmacokinetics and safety of elbasvir/grazoprevir fixed‐dose combination (FDC) in 16 healthy subjects. Elbasvir and grazoprevir each exhibited similar pharmacokinetics following single‐dose administration of elbasvir/grazoprevir with or without famotidine or pantoprazole. Geometric mean ratios (GMRs) of grazoprevir AUC(0,∞), C(max), and C(24) (elbasvir/grazoprevir + famotidine or elbasvir/grazoprevir + pantoprazole vs. elbasvir/grazoprevir) ranged from 0.89–1.17. Similarly, GMRs of elbasvir AUC(0,∞), C(max), and C(24) (elbasvir/grazoprevir + famotidine or elbasvir/grazoprevir + pantoprazole vs. elbasvir/grazoprevir) ranged from 1.02–1.11. These results indicate that gastric acid‐reducing agents do not modify the pharmacokinetics of elbasvir or grazoprevir in a clinically relevant manner and may be coadministered with elbasvir/grazoprevir in HCV‐infected patients without restriction. John Wiley and Sons Inc. 2017-06-17 2017-09 /pmc/articles/PMC5593162/ /pubmed/28625018 http://dx.doi.org/10.1111/cts.12465 Text en © 2017 The Authors. Clinical and Translational Science published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Research
Feng, H‐P
Vaddady, P
Guo, Z
Liu, F
Panebianco, D
Levine, V
Caro, L
Butterton, JR
Iwamoto, M
Yeh, WW
No Pharmacokinetic Interaction Between the Hepatitis C Virus Inhibitors Elbasvir/Grazoprevir and Famotidine or Pantoprazole
title No Pharmacokinetic Interaction Between the Hepatitis C Virus Inhibitors Elbasvir/Grazoprevir and Famotidine or Pantoprazole
title_full No Pharmacokinetic Interaction Between the Hepatitis C Virus Inhibitors Elbasvir/Grazoprevir and Famotidine or Pantoprazole
title_fullStr No Pharmacokinetic Interaction Between the Hepatitis C Virus Inhibitors Elbasvir/Grazoprevir and Famotidine or Pantoprazole
title_full_unstemmed No Pharmacokinetic Interaction Between the Hepatitis C Virus Inhibitors Elbasvir/Grazoprevir and Famotidine or Pantoprazole
title_short No Pharmacokinetic Interaction Between the Hepatitis C Virus Inhibitors Elbasvir/Grazoprevir and Famotidine or Pantoprazole
title_sort no pharmacokinetic interaction between the hepatitis c virus inhibitors elbasvir/grazoprevir and famotidine or pantoprazole
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5593162/
https://www.ncbi.nlm.nih.gov/pubmed/28625018
http://dx.doi.org/10.1111/cts.12465
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