{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:00:47Z","timestamp":1787029247234,"version":"build-2736575974"},"reference-count":38,"publisher":"MDPI AG","issue":"3","license":[{"start":{"date-parts":[[2025,2,22]],"date-time":"2025-02-22T00:00:00Z","timestamp":1740182400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Regione Campania"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pathogens"],"abstract":"<jats:p>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\u2013COVID-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\u20132.345; p = 0.021). Additionally, immunocompromised status (OR 16.929, 95% CI 1.835\u2013156.170; p = 0.013) and chronic non-COVID-19 oxygen therapy (OR 10.714, 95% CI 1.623\u201370.725; 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.<\/jats:p>","DOI":"10.3390\/pathogens14030216","type":"journal-article","created":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T06:47:17Z","timestamp":1740379637000},"page":"216","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Efficacy and Safety of Sotrovimab Versus Oral Antiviral for Early Treatment in High-Risk Patients in Omicron Era: A Multicenter Retrospective Study"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4224-5343","authenticated-orcid":false,"given":"Antonio","family":"Russo","sequence":"first","affiliation":[{"name":"Infectious Diseases, Department of Mental Health and Public Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80131 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariantonietta","family":"Pisaturo","sequence":"additional","affiliation":[{"name":"Infectious Diseases, Department of Mental Health and Public Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80131 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Cacace","sequence":"additional","affiliation":[{"name":"Infectious Diseases, Department of Mental Health and Public Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80131 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Augusta","family":"Troise","sequence":"additional","affiliation":[{"name":"Emergency Unit, PO Santa Maria Delle Grazie, 80078 Pozzuoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabriele","family":"Granata","sequence":"additional","affiliation":[{"name":"Infectious Diseases, Department of Mental Health and Public Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80131 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierantonio","family":"Grimaldi","sequence":"additional","affiliation":[{"name":"Infectious Diseases, Department of Mental Health and Public Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80131 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrico","family":"Allegorico","sequence":"additional","affiliation":[{"name":"Emergency Unit, PO Santa Maria Delle Grazie, 80078 Pozzuoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Ambrisi","sequence":"additional","affiliation":[{"name":"Infectious Diseases, Department of Mental Health and Public Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80131 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martina","family":"Papillo","sequence":"additional","affiliation":[{"name":"Emergency Unit, PO Santa Maria Delle Grazie, 80078 Pozzuoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabio Giuliano","family":"Numis","sequence":"additional","affiliation":[{"name":"Emergency Unit, PO Santa Maria Delle Grazie, 80078 Pozzuoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5897-4949","authenticated-orcid":false,"given":"Nicola","family":"Coppola","sequence":"additional","affiliation":[{"name":"Infectious Diseases, Department of Mental Health and Public Medicine, University of Campania \u201cL. Vanvitelli\u201d, 80131 Napoli, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,2,22]]},"reference":[{"key":"ref_1","unstructured":"Centers for Disease Control and Prevention (2024, December 30). COVID Data Tracker, Available online: https:\/\/covid.cdc.gov\/covid-data-tracker\/."},{"key":"ref_2","doi-asserted-by":"crossref","unstructured":"Russo, A., Pisaturo, M., Zollo, V., Martini, S., Maggi, P., Numis, F.G., Gentile, I., Sangiovanni, N., Rossomando, A.M., and Bianco, V. (2023). Obesity as a Risk Factor of Severe Outcome of COVID-19: A Pair-Matched 1:2 Case-Control Study. J. Clin. Med., 12.","DOI":"10.3390\/jcm12124055"},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"90","DOI":"10.1007\/s12016-022-08921-5","article-title":"Risk and Protective Factors for COVID-19 Morbidity, Severity, and Mortality","volume":"64","author":"Zhang","year":"2023","journal-title":"Clin. Rev. 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