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Comparative Study
. 2025 Feb 22;14(3):216.
doi: 10.3390/pathogens14030216.

Efficacy and Safety of Sotrovimab Versus Oral Antiviral for Early Treatment in High-Risk Patients in Omicron Era: A Multicenter Retrospective Study

Antonio Russo  1 , Mariantonietta Pisaturo  1 , Chiara Cacace  1 , Augusta Troise  2 , Gabriele Granata  1 , Pierantonio Grimaldi  1 , Enrico Allegorico  2 , Francesca Ambrisi  1 , Martina Papillo  2 , Fabio Giuliano Numis  2 , Nicola Coppola  1
Affiliations
Comparative Study

Efficacy and Safety of Sotrovimab Versus Oral Antiviral for Early Treatment in High-Risk Patients in Omicron Era: A Multicenter Retrospective Study

Antonio Russo et al. Pathogens. .

Abstract

Introduction: High-risk patients with COVID-19 benefit from early treatment to prevent severe outcomes. Sotrovimab, a monoclonal antibody, and oral antivirals such as nirmatrelvir/ritonavir and molnupiravir have been used for early intervention, but their comparative efficacy and safety, particularly during the Omicron-dominant phase, require further evaluation.

Methods: A multicenter, retrospective study performed in southern Italy including all adult patients who received early antiviral treatment (sotrovimab or nirmatrelvir/r or molnupiravir) between January 2022 and February 2024 (omicron phase). Demographic, clinical, and treatment-related data were analyzed to assess primary endpoints of 28-day mortality and hospitalization. Logistic regression models identified predictors of key outcomes.

Results: A total of 668 high-risk patients treated with sotrovimab (n = 326) or oral antivirals (n = 342: 69 with molnupiravir and 273 with nirmatrelvir/ritonavir) were included. There was no significant difference in 28-day mortality between groups (0.8% sotrovimab vs. 1.8% oral antivirals; p = 0.679). However, patients treated with sotrovimab exhibited a longer median time to SARS-CoV-2 negativization (13 vs. 11 days; p = 0.008) and higher non-COVID-19-related hospitalizations (2.45% vs. 0%; p = 0.003). Multivariable analysis identified cardiovascular or cerebrovascular diseases as the sole significant predictor of prolonged viral positivity (OR 1.585, 95% CI 1.072-2.345; p = 0.021). Additionally, immunocompromised status (OR 16.929, 95% CI 1.835-156.170; p = 0.013) and chronic non-COVID-19 oxygen therapy (OR 10.714, 95% CI 1.623-70.725; p = 0.014) were strongly associated with mortality.

Conclusions: Sotrovimab and oral antivirals demonstrated similar efficacy in preventing mortality and hospitalization among high-risk patients. Patient-specific factors, particularly cardiovascular comorbidities and immunosuppression, significantly influenced outcomes and should guide treatment choices.

Keywords: COVID-19; Omicron variant; SARS-CoV-2 infection; early therapy; safety; sotrovimab.

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Conflict of interest statement

The authors declare no conflicts of interest.

References

    1. Centers for Disease Control and Prevention COVID Data Tracker. [(accessed on 30 December 2024)];2022 Available online: https://covid.cdc.gov/covid-data-tracker/
    1. Russo A., Pisaturo M., Zollo V., Martini S., Maggi P., Numis F.G., Gentile I., Sangiovanni N., Rossomando A.M., Bianco V., et al. Obesity as a Risk Factor of Severe Outcome of COVID-19: A Pair-Matched 1:2 Case-Control Study. J. Clin. Med. 2023;12:4055. doi: 10.3390/jcm12124055. - DOI - PMC - PubMed
    1. Zhang J.J., Dong X., Liu G.H., Gao Y.D. Risk and Protective Factors for COVID-19 Morbidity, Severity, and Mortality. Clin. Rev. Allergy Immunol. 2023;64:90–107. doi: 10.1007/s12016-022-08921-5. - DOI - PMC - PubMed
    1. Russo A., Pisaturo M., Palladino R., Maggi P., Numis F.G., Gentile I., Sangiovanni V., Esposito V., Punzi R., Calabria G., et al. Prognostic Value of Transaminases and Bilirubin Levels at Admission to Hospital on Disease Progression and Mortality in Patients with COVID-19-An Observational Retrospective Study. Pathogens. 2022;11:652. doi: 10.3390/pathogens11060652. - DOI - PMC - PubMed
    1. Akpoviroro O., Sauers N.K., Uwandu Q., Castagne M., Akpoviroro O.P., Humayun S., Mirza W., Woodard J. Severe COVID-19 infection: An institutional review and literature overview. PLoS ONE. 2024;19:e0304960. doi: 10.1371/journal.pone.0304960. Erratum in PLoS ONE 2024, 19, e0310284. https://doi.org/10.1371/journal.pone.0310284. - DOI - PMC - PubMed

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