Liver related adverse events reported in WHO database with use of remdesivir in COVID-19

ABSTRACT

Objectives: Remdesivir was granted emergency approval for use in the management of COVID-19 though some studies exhibit concerns regarding its effectiveness, it is still being used for COVID-19 infection management in many parts of the globe. To date, limited data is available regarding its safety as it's a newer drug. Thus there is a need to observe and record its adverse events to aid future decisions. This study was designed with the aim of analyzing the liver-related adverse drug events (ADEs) reported in VigiBase, the WHO database for adverse event reporting. Materials and Methods: The analysis of all suspected adverse events related to remdesivir reported in the last 5 years to VigiBase®, i.e. from January 1, 2015, to July 19, 2020, was performed. We used SOC (System Organ Class) information and PT (Preferred Terms) for analysis in the present study. We extracted three SOCs - hepatobiliary disorders, gastrointestinal disorders, and investigations. Descriptive statistics were reported in the form of frequency and percentages. Results: The majority of ADEs were reported from males and the majority were serious in nature. A total of 1086 ADEs were reported from the 439 individuals up to July 19, 2020, in the VigiBase®, after exclusion of duplicates1004 ADE were analyzed. out of this 18.12% (182 of 1004), ADE was related to the liver from 142 subjects. The most common ADE were alternations in the liver enzymes with Alanine aminotransferase increased 4.98% (50 of 1004), 3.19% (32 pf 1004) of increase in Aspartate Aminotransferase, and increased in transaminase increased in 2. 39% (24 of 1004). Conclusion: Deterioration of liver functions was observed with the use of remdesivir in a few patients. A thorough review of cases and proportionality analysis should be done to ascertain the causality of these adverse events as COVID-19 infection may itself leads to an increase in liver enzymes.