Literature DB >> 28444890

Utilizing PBPK Modeling to Evaluate the Potential of a Significant Drug-Drug Interaction Between Clopidogrel and Dasabuvir: A Scientific Perspective.

V Arya1, P Zhao2, K S Reynolds1, P Mishra3, I R Younis1.   

Abstract

Dasabuvir, a component of VIEKIRA PAK, is a substrate of CYP2C8 enzymes. Prescribing information for VIEKIRA PAK contraindicates gemfibrozil, a strong CYP2C8 inhibitor, because coadministration significantly increases dasabuvir exposures, which may increase the risk of QT prolongation. Clopidogrel may increase dasabuvir exposures primarily due to CYP2C8 inhibition by clopidogrel-acyl-β-D-glucuronide. This commentary outlines the US Food and Drug Administration (FDA) interdisciplinary review team's scientific perspective to address the potential for a significant drug-drug interaction (DDI) between clopidogrel and VIEKIRA PAK. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

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Year:  2017        PMID： 28444890     DOI： 10.1002/cpt.699

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  6 in total

1.  Quantitative Assessment of Elagolix Enzyme-Transporter Interplay and Drug-Drug Interactions Using Physiologically Based Pharmacokinetic Modeling.

Authors:  Manoj S Chiney; Juki Ng; John P Gibbs; Mohamad Shebley
Journal:  Clin Pharmacokinet       Date:  2020-05       Impact factor: 6.447

Review 2.  Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.

Authors:  Mohamad Shebley; Punam Sandhu; Arian Emami Riedmaier; Masoud Jamei; Rangaraj Narayanan; Aarti Patel; Sheila Annie Peters; Venkatesh Pilla Reddy; Ming Zheng; Loeckie de Zwart; Maud Beneton; Francois Bouzom; Jun Chen; Yuan Chen; Yumi Cleary; Christiane Collins; Gemma L Dickinson; Nassim Djebli; Heidi J Einolf; Iain Gardner; Felix Huth; Faraz Kazmi; Feras Khalil; Jing Lin; Aleksandrs Odinecs; Chirag Patel; Haojing Rong; Edgar Schuck; Pradeep Sharma; Shu-Pei Wu; Yang Xu; Shinji Yamazaki; Kenta Yoshida; Malcolm Rowland
Journal:  Clin Pharmacol Ther       Date:  2018-02-02       Impact factor: 6.875

3.  Requirements to Establishing Confidence in Physiologically Based Pharmacokinetic (PBPK) Models and Overcoming Some of the Challenges to Meeting Them.

Authors:  Sheila Annie Peters; Hugues Dolgos
Journal:  Clin Pharmacokinet       Date:  2019-11       Impact factor: 6.447

Review 4.  Inhibition of CYP2C8 by Acyl Glucuronides of Gemfibrozil and Clopidogrel: Pharmacological Significance, Progress and Challenges.

Authors:  Manish B Shah
Journal:  Biomolecules       Date:  2022-09-01

Review 5.  Utilization of Physiologically Based Pharmacokinetic Modeling in Clinical Pharmacology and Therapeutics: an Overview.

Authors:  Courtney Perry; Grace Davis; Todd M Conner; Tao Zhang
Journal:  Curr Pharmacol Rep       Date:  2020-05-12

6.  Clopidogrel Increases Dasabuvir Exposure With or Without Ritonavir, and Ritonavir Inhibits the Bioactivation of Clopidogrel.

Authors:  Matti K Itkonen; Aleksi Tornio; Outi Lapatto-Reiniluoto; Mikko Neuvonen; Pertti J Neuvonen; Mikko Niemi; Janne T Backman
Journal:  Clin Pharmacol Ther       Date:  2018-08-09       Impact factor: 6.875
  6 in total

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