Products Cited in Publications Worldwide The Transfer of Molnupiravir and Nirmatrelvir Across the Human Placenta and Prediction of Drug Safety in Pregnancy

The Transfer of Molnupiravir and Nirmatrelvir Across the Human Placenta and Prediction of Drug Safety in Pregnancy

Zabek, Magdalene

Abstract

and nirmatrelvir are effective COVID-19 therapeutics, however there is limited data on their safety during pregnancy. The objective is to quantify the placental transfer of nirmatrelvir and (NHC), the metabolite of found in plasma. A systematic review on the pharmacokinetics of nirmatrelvir found no data in pregnant subjects, though several studies reported parameters in non-pregnant individuals such as CL, VD, and fu. Using the ex vivo human placental perfusion model, nirmatrelvir showed a fetal-maternal concentration ratio (F:M) of 0.34 at therapeutic doses (2.21 µg/mL) and 0.46 (22.1 µg/mL) at supratherapeutic doses. Adjusted F:M for non-placental physiological factors ranged from 0.26-0.35 (2.21 µg/mL) and 0.38-0.51 (22.1 µg/mL). For , the F:M was (2.97µg/mL) and (29.7 µg/mL). Results suggest that therapeutic and supratherapeutic doses of nirmatrelvir and can passively cross the placental barrier. This data can be considered to create better safety recommendations regarding their use in pregnancy.

Keywords

COVID-19 ; placental perfusion ; pregnancy ; nirmatrelvir ; ; pharmacokinetics ; placental transfer ; drug safety ; nucleoside analogue ; main protease inhibitor

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EIDD-1931

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EIDD-1931

33.0/250mg

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