A recent study has shed light on the pharmacokinetics and safety of intravenous remdesivir for treating SARS-CoV-2 in pregnant women. Remdesivir, an antiviral medication, is primarily used for patients with COVID-19 who are either hospitalized or experiencing mild-to-moderate symptoms in outpatient care, especially those at high risk for severe disease.
Published in the Journal of Infectious Diseases, this study is the first to examine the pharmacokinetics of a COVID-19 therapy specifically in pregnant women. Pharmacokinetic studies are crucial as they analyze how drugs behave in the body, including their distribution, metabolism, and elimination, to ensure safe and effective dosages.
Kristina Brooks, PharmD, an assistant professor at the University of Colorado Skaggs School of Pharmacy, emphasized the lack of clinical research focusing on pregnant individuals, which often leaves healthcare providers without critical data on drug dosage and safety for this population.
To explore the pharmacokinetics and safety of remdesivir, Brooks collaborated with the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) on a phase 4 open-label study involving over fifty pregnant and nonpregnant women hospitalized and receiving intravenous remdesivir as part of their care.
Noting the heightened risk of severe COVID-19 and adverse pregnancy outcomes in pregnant women, the research team aimed to determine the safety and effectiveness of remdesivir for this group.
The researchers conducted detailed pharmacokinetic sampling during the treatment of remdesivir and measured levels of the drug and its metabolites in the participants. They discovered that the levels of remdesivir in pregnant women were comparable to those in nonpregnant women, indicating that no dosage adjustments are necessary for pregnant patients. Additionally, there were no safety issues noted, nor any adverse pregnancy outcomes, maternal deaths, or congenital anomalies related to the drug, although the study size was limited.
The results contributed to the approval of a supplemental new drug application by the U.S. Food and Drug Administration and a positive opinion from the European Medicines Agency, which supported labeling changes for remdesivir for use in pregnant individuals.
The research was conducted within the IMPAACT Network, a global collaboration involving various institutions and partners, with support from Gilead Sciences, Inc. Brooks highlighted the significance of conducting this study efficiently within this established network, reinforcing that pharmacokinetic and safety studies in pregnant populations are essential, particularly in the context of emerging infectious diseases and appropriate medication dosing for this demographic.