Monitoring the emergence of resistance with sotrovimab in immunocompromised patients with COVID-19: LUNAR study
Judith Breuer, Myriam Drysdale, Jill Walker, Jennifer Han, Alicia Aylott, Melissa K Van Dyke, Helen J Birch, Elizabeth Mckie, William Jordan, Kim Gemzoe, Iain A Gillespie, Claire Bethune, Charlotte A Williams, Jonathan Underwood, Anna L Goodman, Michael Brown, Julianne R Brown, Rachel Williams, Luz Marina Martin Bernal, Laura Buggiotti, Effrossyni Gkrania-Klotsas, Clara Green, Ewan Hunter, Charles Miller, Andrew Skingsley, David M Lowe
Journal of Infection, doi:10.1016/j.jinf.2025.106510
s u m m a r y Objectives: To assess outcomes in sotrovimab-treated immunocompromised patients in the United Kingdom. Methods: Multicenter, prospective, observational, descriptive study in immunocompromised, non-hospitalized adults infected with SARS-CoV-2 who received intravenous sotrovimab 500 mg as standard-of-care (July 1, 2022-June 30, 2023; Omicron predominance). Virology analyses included determination of SARS-CoV-2 viral load, spike sequencing, and determination of amino-acid substitutions in the spike protein and sotrovimab epitope. Results: The proportion of participants (N = 217) with undetectable SARS-CoV-2 RNA was 25.1% at day 7, 65.8% at day 14%, and 83.5% at day 28. Of 156 participants with paired sequences, 101 (64.7%) and 47 (30.1%) had treatmentemergent substitutions at > 50% allelic frequency in the spike protein and sotrovimab epitope, respectively, at any post-baseline timepoint. Ten treatment-emergent substitutions (at positions 337, 340, and 356) were identified in the epitope at > 50% allelic frequency. Five of 18 (27.8%) participants with, versus 22/30 (73.3%) of those without, treatment-emergent epitope substitutions at day 14 achieved undetectable SARS-CoV-2 RNA levels at day 28. Conclusions: In this immunocompromised population infected with SARS-CoV-2 who received early treatment with sotrovimab, most participants (83.5%) experienced substantial viral load reductions by day 28. Treatmentemergent substitutions occurred in the sotrovimab epitope, including substitutions known to reduce susceptibility in vitro. Several treatment-emergent substitutions were associated with viral persistence.
Authorship All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Author contributions All authors made a significant contribution to the work reported, whether that was in the conception, study design, execution, acquisition of data, analysis or interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the manuscript; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Ethics approval The study protocol, any amendments, the informed consent, and other information that required pre-approval were reviewed and approved by an Ethics Committee (IRAS reference 1005346; reference number 22/SC/0099) in accordance with ethical principles founded in the Declaration of Helsinki (version 2008) and applicable UK requirements. Written informed consent was obtained from each participant prior to the performance of any study-specific procedures.
Appendix A. Supporting information Supplementary data associated with this article can be found in the online version at doi:10.1016/j.jinf.2025.106510.
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