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Mar 3, 2021
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Assessment of the Mechanism for Remdesivir-Associated Clinical ALT Elevations Using DILIsym Quantitative Systems Toxicology Modeling

Introduction

• Remdesivir, a monophosphoramidate prodrug of a nucleoside analog, has been granted Emergency Use Authorization in the U.S. for the treatment of hospitalized COVID-19 patients.
• In a Ph1 clinical study in healthy volunteers treated with the 150 mg daily dose of remdesivir for 7 or 14 days (higher than the current clinical dose) [1], reversible low- grade elevations of serum ALT and AST were observed at 5-25 days after the first dose in 8 out of 16 individuals.

By Kyunghee Yang

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Presented at SLP MIDD+ Virtual Conference March 3-4, 2021

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