Preliminary Evidence of Good Safety Profile and Outcomes of Early Treatment With Tixagevimab/Cilgavimab Compared to Previously Employed Monoclonal Antibodies for COVID-19 in Immunocompromised Patients
MD. Andrea Lombardi, Giulia Viero, Simone Villa, Simona Biscarini, Emanuele Palomba, Cecilia Azzara', Nathalie Iannotti, Bianca Mariani, Camilla Genovese, Mara Tomasello, Anna Tonizzo, Marco Fava, Antonia Grazia Valzano, Letizia Morlacchi, Maria Francesca Donato, Giuseppe Castellano, Ramona Cassin, Maria Carrabba, Antonio Muscatello, Andrea Gori, Alessandra Bandera
doi:10.20944/preprints202301.0359.v1
The statements, opinions, and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions, or products referred to in the content.
Authors contributions AL, SV, AG, and AB conceived the study. GV, SB, EP, CA, NI, BM, CG, MT, AT, MF, AGV, LCM, FD, GC, RC, MC and AM enrolled the patients and collected clinical data. AL and SV performed the statistical analysis. AL, GV and SV wrote the first draft of the manuscript. All the other authors reviewed the final version of the manuscript.
Conflict of interests AL Gilead Sciences Inc. and Insmed Italia. AB Quiagen, Pfizer, Nordic Pharma, ViiV, SOBI, and Gilead Sciences. FD Kedrion, Gilead Sciences, Biotest, and Novartis. AM Gilead Sciences, Menarini, and Nordic Pharma. SB Infectopharma. MC Takeda and Kedrion. All the other authors have nothing to declare.
References
Aifa, AIFA Evusheld trattamento 2022
Biscarini, Villa, Genovese, Tomasello, Tonizzo et al., Safety Profile and Outcomes of Early COVID-19 Treatments in Immunocompromised Patients: A Single-Centre Cohort Study, Biomedicines,
doi:10.3390/biomedicines10082002Ecdc, ECDC VOCs monitoring
Holland, Ginde, Paredes, Murray, Engen et al., Tixagevimabcilgavimab for treatment of patients hospitalised with COVID-19: a randomised, doubleblind, phase 3 trial, Lancet Respir Med,
doi:10.1016/S2213-2600(22)00215-6Jurdi, Morena, Cote, Bethea, Azzi et al., Tixagevimab/cilgavimab preexposure prophylaxis is associated with lower breakthrough infection risk in vaccinated solid organ transplant recipients during the omicron wave, Am J Transplant,
doi:10.1111/ajt.17128Levin, Ustianowski, Wit, Launay, Avila et al., Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19, N Engl J Med,
doi:10.1056/NEJMoa2116620Loo, Mctamney, Arends, Abram, Aksyuk et al., The SARS-CoV-2 monoclonal antibody combination, AZD7442, is protective in nonhuman primates and has an extended half-life in humans, Sci Transl Med,
doi:10.1126/scitranslmed.abl8124Mcconnell, Harte, Walsh, Murphy, Barry, Comparative effectiveness of neutralising monoclonal antibodies in high risk COVID-19 patients: a Bayesian network meta-analysis, Sci Rep,
doi:10.1038/s41598-022-22431-6Montgomery, Hobbs, Padilla, Arbetter, Templeton et al., Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial, Lancet Respir Med,
doi:10.1016/S2213-2600(22)00180-1Nguyen, Flahault, Chavarot, Melenotte, Cheminant et al., Preexposure prophylaxis with tixagevimab and cilgavimab (Evusheld) for COVID-19 among 1112 severely immunocompromised patients, Clin Microbiol Infect,
doi:10.1016/j.cmi.2022.07.015
