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Concomitant Intake of Coca‐Cola to Manage the Drug–Drug Interaction Between Velpatasvir and Omeprazole Studied in Healthy Volunteers

We aimed to evaluate the effect of the acid beverage Coca‐Cola on the pharmacokinetics of velpatasvir (VEL) when given with omeprazole. This was an open‐label, randomized, crossover trial in 11 healthy adults. A single dose of sofosbuvir/velpatasvir (SOF/VEL) 400/100 mg was administered alone (refer...

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Autores principales: van Seyen, Minou, Colbers, Angela, Abbink, Evertine J., Drenth, Joost P.H., Burger, David M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6851656/
https://www.ncbi.nlm.nih.gov/pubmed/31313296
http://dx.doi.org/10.1002/cpt.1569
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author van Seyen, Minou
Colbers, Angela
Abbink, Evertine J.
Drenth, Joost P.H.
Burger, David M.
author_facet van Seyen, Minou
Colbers, Angela
Abbink, Evertine J.
Drenth, Joost P.H.
Burger, David M.
author_sort van Seyen, Minou
collection PubMed
description We aimed to evaluate the effect of the acid beverage Coca‐Cola on the pharmacokinetics of velpatasvir (VEL) when given with omeprazole. This was an open‐label, randomized, crossover trial in 11 healthy adults. A single dose of sofosbuvir/velpatasvir (SOF/VEL) 400/100 mg was administered alone (reference) or with omeprazole 40 mg once daily with water (intervention I); in the intervention II arm, omeprazole 40 mg was combined with 250 mL of Coca‐Cola. Geometric mean ratios (GMRs) were calculated for VEL area under the concentration‐time curve from zero to infinity (AUC (0−inf)) and maximum plasma concentration (C(max)). VEL exposure was reduced by 26.7% when SOF/VEL was coadministered with omeprazole vs. reference: GMRs (90% confidence interval (CI)) were 73.3% (55.6–96.8) and 69.1% (52.3–91.2) for AUC (0‐inf) and C(max), respectively. Intake of SOF/VEL with Coca‐Cola compensated for the interaction with omeprazole and resulted in a higher VEL exposure. GMRs (90% CI) were 161.6% (122.4–213.3) for AUC (0‐inf) and 143.9% (109.0–190.0) for C(max). Therefore, Coca‐Cola can be used to overcome the drug–drug interaction between VEL and omeprazole.
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spelling pubmed-68516562019-12-12 Concomitant Intake of Coca‐Cola to Manage the Drug–Drug Interaction Between Velpatasvir and Omeprazole Studied in Healthy Volunteers van Seyen, Minou Colbers, Angela Abbink, Evertine J. Drenth, Joost P.H. Burger, David M. Clin Pharmacol Ther Research We aimed to evaluate the effect of the acid beverage Coca‐Cola on the pharmacokinetics of velpatasvir (VEL) when given with omeprazole. This was an open‐label, randomized, crossover trial in 11 healthy adults. A single dose of sofosbuvir/velpatasvir (SOF/VEL) 400/100 mg was administered alone (reference) or with omeprazole 40 mg once daily with water (intervention I); in the intervention II arm, omeprazole 40 mg was combined with 250 mL of Coca‐Cola. Geometric mean ratios (GMRs) were calculated for VEL area under the concentration‐time curve from zero to infinity (AUC (0−inf)) and maximum plasma concentration (C(max)). VEL exposure was reduced by 26.7% when SOF/VEL was coadministered with omeprazole vs. reference: GMRs (90% confidence interval (CI)) were 73.3% (55.6–96.8) and 69.1% (52.3–91.2) for AUC (0‐inf) and C(max), respectively. Intake of SOF/VEL with Coca‐Cola compensated for the interaction with omeprazole and resulted in a higher VEL exposure. GMRs (90% CI) were 161.6% (122.4–213.3) for AUC (0‐inf) and 143.9% (109.0–190.0) for C(max). Therefore, Coca‐Cola can be used to overcome the drug–drug interaction between VEL and omeprazole. John Wiley and Sons Inc. 2019-08-18 2019-11 /pmc/articles/PMC6851656/ /pubmed/31313296 http://dx.doi.org/10.1002/cpt.1569 Text en © 2019 The Authors. Clinical Pharmacology & Therapeutics 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 http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Research
van Seyen, Minou
Colbers, Angela
Abbink, Evertine J.
Drenth, Joost P.H.
Burger, David M.
Concomitant Intake of Coca‐Cola to Manage the Drug–Drug Interaction Between Velpatasvir and Omeprazole Studied in Healthy Volunteers
title Concomitant Intake of Coca‐Cola to Manage the Drug–Drug Interaction Between Velpatasvir and Omeprazole Studied in Healthy Volunteers
title_full Concomitant Intake of Coca‐Cola to Manage the Drug–Drug Interaction Between Velpatasvir and Omeprazole Studied in Healthy Volunteers
title_fullStr Concomitant Intake of Coca‐Cola to Manage the Drug–Drug Interaction Between Velpatasvir and Omeprazole Studied in Healthy Volunteers
title_full_unstemmed Concomitant Intake of Coca‐Cola to Manage the Drug–Drug Interaction Between Velpatasvir and Omeprazole Studied in Healthy Volunteers
title_short Concomitant Intake of Coca‐Cola to Manage the Drug–Drug Interaction Between Velpatasvir and Omeprazole Studied in Healthy Volunteers
title_sort concomitant intake of coca‐cola to manage the drug–drug interaction between velpatasvir and omeprazole studied in healthy volunteers
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6851656/
https://www.ncbi.nlm.nih.gov/pubmed/31313296
http://dx.doi.org/10.1002/cpt.1569
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