A new study offers crucial insights into the pharmacokinetics and safety of intravenous remdesivir for treating SARS-CoV-2 in pregnant women.
Remdesivir is an antiviral medication used to treat COVID-19 patients with hospitalized or mild-to-moderate symptoms in outpatient settings at high risk of severe disease.
This study was recently published in The Journal of Infectious Diseases and is the first pharmacokinetic study on COVID-19 therapy in pregnant women. Pharmacokinetic studies help researchers understand drug concentrations, distribution, and elimination from the body, and this ensures safe and effective doses for treating the condition.
One of the researchers, Kristina Brooks, said that pregnant individuals are often overlooked in clinical research. This led to limited data on the appropriate dosage, safety, and effectiveness of medications for this population.
Researchers conducted a phase 4 open-label, nonrandomized study on the pharmacokinetics and safety of remdesivir. In this study, researchers involved over fifty hospitalized pregnant and nonpregnant women.
Pregnant women are at a higher risk of severe COVID-19 disease and poorer pregnancy outcomes. Hence, researchers wanted to understand the safety and effectiveness of COVID-19 treatments, such as remdesivir, when they are given at appropriate doses.
Researchers conducted pharmacokinetic sampling on days 3, 4, or 5 of remdesivir treatment. They measured plasma levels of remdesivir, its major metabolites, and active triphosphate form in peripheral blood mononuclear cells.
When researchers observed the collected data, they found that remdesivir and its metabolites were similar in levels in pregnant and nonpregnant women. This indicated that there was no need for dose adjustments. Also, they did not find any safety concerns and adverse pregnancy outcomes, cognitive anomalies, or maternal death that were related to remdesivir, though the study size was limited.
This study was conducted within the IMPAACT Network. It is a global collaboration of investigators, institutions, community representatives, and other partners.
Brook further said that this study shows the importance of conducting pharmacokinetic and safety studies in pregnant populations, particularly in challenging settings, to inform the appropriate dosing of medications, especially in the context of emerging infectious diseases.
Reference Link:
Kristina M Brooks et al, Pharmacokinetics and Safety of Remdesivir in Pregnant and Nonpregnant Women With COVID-19: Results From IMPAACT 2032, The Journal of Infectious Diseases (2024).
