USE OF SOTROVIMAB IN PREGNANCY

Sotrovimab is an IgG1 monoclonal antibody which binds to a conserved epitope on the spike protein receptor binding domain of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), thereby inhibiting viral fusion to the cell membrane. It is licensed for the treatment of symptomatic acute coronavirus disease 2019 (COVID-19) infection in people who do not require oxygen supplementation but are at increased risk of severe COVID-19. The National Institute for Health and Care Excellence (NICE) guidelines recommend that sotrovimab can be considered where nirmatrelvir/ritonavir is contraindicated or unsuitable.

Although pregnant women without comorbidities do not appear to be more likely to contract SARS-CoV-2 than the general population, increased risks have been described for those with pre-existing diabetes, gestational diabetes requiring insulin treatment, and in those who are overweight or obese. However, pregnant women are at increased risk of developing severe COVID-19, particularly in late pregnancy. Increased risks of adverse pregnancy outcomes, including growth restriction, preterm delivery and stillbirth have also been described. Where indicated, treatments for COVID-19 should not be withheld on account of pregnancy.

Published data regarding sotrovimab exposure in pregnancy are limited, and although there is no compelling evidence indicating increased risks of adverse pregnancy, fetal or neonatal outcomes, additional studies are required before more definitive conclusions can be provided. Where nirmatrelvir/ritonavir is contraindicated or unsuitable and the benefits of treatment are expected to outweigh the risks, sotrovimab can be considered for use in pregnant women with COVID-19.

Exposure to sotrovimab at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring. However, other risk factors which could independently increase the risk of adverse pregnancy outcome may be present in individual cases. Such factors are important to consider when performing case-specific risk assessments.