What Is the Efficacy of Sotrovimab in Reducing Disease Progression and Death in People with COVID-19 during the Omicron Era? Answers from a Real-Life Study

{ 'indexed': {'date-parts': [[2023, 8, 20]], 'date-time': '2023-08-20T05:05:54Z', 'timestamp': 1692507954938}, 'reference-count': 46, 'publisher': 'MDPI AG', 'issue': '8', 'license': [ { 'start': { 'date-parts': [[2023, 8, 17]], 'date-time': '2023-08-17T00:00:00Z', 'timestamp': 1692230400000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0/'}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'abstract': '<jats:p>(1) Introduction: Since May 2021, sotrovimab has been available in Italy for early ' 'treatment of SARS-CoV-2 infection and to prevent disease progression. However, some in vitro ' 'studies have questioned its efficacy on Omicron variants. Therefore, we aim to further ' 'investigate the efficacy of sotrovimab in real-life settings. (2) Methods: We conducted a ' 'retrospective study collecting medical records of people with SARS-CoV-2 infection evaluated ' 'in the infectious diseases units of Sassari, Foggia, and Bari, Italy. We included people with ' 'SARS-CoV-2 infection treated with sotrovimab and people who did not receive any treatment in ' '2022. The primary study outcome was to evaluate the efficacy of sotrovimab in reducing ' 'disease progression (defined as the necessity of starting oxygen supplementation) and ' 'COVID-19-related death. The secondary outcome was to evaluate the safety of sotrovimab. (3) ' 'Results: We included 689 people; of them, 341 were treated with sotrovimab, while 348 did not ' 'receive any treatment. Overall, we registered 161 (23.4%) disease progressions and 65 (9.4%) ' 'deaths, with a significant difference between treated and not-treated people (p &lt; 0.001). ' 'In the multivariate logistic regression, increasing age [OR for ten years increasing age 1.23 ' '(95%CI 1.04–1.45)] was associated with a higher risk of disease progression. In addition, ' 'cardiovascular disease [OR 1.69 (1.01–2.80), fever [OR 3.88 (95%CI 2.35–6.38)], and dyspnea ' '[OR 7.24 (95%CI 4.17–12.58)] were associated with an increased risk of disease progression. ' 'In contrast, vaccination [OR 0.21 (95%CI 0.12–0.37)] and sotrovimab administration [OR 0.05 ' '(95%CI 0.02–0.11)] were associated with a lower risk of developing severe COVID-19. Regarding ' 'mortality, people with older age [OR for ten years increasing age 1.36 (95%CI 1.09–1.69)] had ' 'a higher risk of death. In addition, in the multivariate analysis, cardiovascular disease ' 'lost statistical significance, while people on chemotherapy for haematological cancer [OR ' '4.07 (95%CI 1.45–11.4)] and those with dyspnea at diagnosis [OR 3.63 (95%CI 2.02–6.50)] had ' 'an increased risk of death. In contrast, vaccination [OR 0.37 (95%CI 0.20–0.68)] and ' 'sotrovimab treatment [OR 0.16 (95%CI 0.06–0.42)] were associated with lower risk. Only two ' 'adverse events were reported; one person complained of diarrhoea a few hours after sotrovimab ' 'administration, and one had an allergic reaction with cutaneous rash and itching. (4) ' 'Conclusions: Our study showed that sotrovimab treatment was associated with a reduction of ' 'the risk of disease progression and death in SARS-CoV-2-infected people, 70% of whom were ' 'over 65 years and a with high vaccination rate, with excellent safety. Therefore, our results ' 'reinforce the evidence about the efficacy and safety of sotrovimab during the Omicron era in ' 'a real-world setting.</jats:p>', 'DOI': '10.3390/v15081757', 'type': 'journal-article', 'created': {'date-parts': [[2023, 8, 17]], 'date-time': '2023-08-17T14:15:48Z', 'timestamp': 1692281748000}, 'page': '1757', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'What Is the Efficacy of Sotrovimab in Reducing Disease Progression and Death in People with ' 'COVID-19 during the Omicron Era? Answers from a Real-Life Study', 'prefix': '10.3390', 'volume': '15', 'author': [ { 'ORCID': 'http://orcid.org/0000-0002-8265-5400', 'authenticated-orcid': False, 'given': 'Andrea', 'family': 'De Vito', 'sequence': 'first', 'affiliation': [ { 'name': 'Unit of Infectious Diseases, Department of Medicine, Surgery, ' 'and Pharmacy, University of Sassari, 07100 Sassari, Italy'}]}, { 'ORCID': 'http://orcid.org/0000-0002-8959-1403', 'authenticated-orcid': False, 'given': 'Agnese', 'family': 'Colpani', 'sequence': 'additional', 'affiliation': [ { 'name': 'Unit of Infectious Diseases, Department of Medicine, Surgery, ' 'and Pharmacy, University of Sassari, 07100 Sassari, Italy'}]}, { 'ORCID': 'http://orcid.org/0000-0002-9896-489X', 'authenticated-orcid': False, 'given': 'Mariacristina', 'family': 'Poliseno', 'sequence': 'additional', 'affiliation': [ { 'name': 'S.C. Malattie Infettive, Dipartimento di Medicina Clinica e ' 'Sperimentale, University of Foggia, 71100 Foggia, Italy'}]}, { 'given': 'Lucia', 'family': 'Diella', 'sequence': 'additional', 'affiliation': [ { 'name': 'Clinic of Infectious Diseases, Department of Precision and ' 'Regenerative Medicine and Ionian Area—(DiMePRe-J), University of ' 'Bari “Aldo Moro”, Piazza Giulio Cesare n. 11, 70100 Bari, ' 'Italy'}]}, { 'given': 'Francesco Rosario Paolo', 'family': 'Ieva', 'sequence': 'additional', 'affiliation': [ { 'name': 'S.C. Malattie Infettive, Dipartimento di Medicina Clinica e ' 'Sperimentale, University of Foggia, 71100 Foggia, Italy'}]}, { 'given': 'Alessandra', 'family': 'Belati', 'sequence': 'additional', 'affiliation': [ { 'name': 'Clinic of Infectious Diseases, Department of Precision and ' 'Regenerative Medicine and Ionian Area—(DiMePRe-J), University of ' 'Bari “Aldo Moro”, Piazza Giulio Cesare n. 11, 70100 Bari, ' 'Italy'}]}, { 'given': 'Roberto', 'family': 'Papale', 'sequence': 'additional', 'affiliation': [ { 'name': 'S.C. Malattie Infettive, Dipartimento di Medicina Clinica e ' 'Sperimentale, University of Foggia, 71100 Foggia, Italy'}]}, { 'ORCID': 'http://orcid.org/0000-0001-7291-8687', 'authenticated-orcid': False, 'given': 'Sergio', 'family': 'Babudieri', 'sequence': 'additional', 'affiliation': [ { 'name': 'Unit of Infectious Diseases, Department of Medicine, Surgery, ' 'and Pharmacy, University of Sassari, 07100 Sassari, Italy'}]}, { 'given': 'Laura', 'family': 'De Santis', 'sequence': 'additional', 'affiliation': [ { 'name': 'Clinic of Infectious Diseases, Department of Precision and ' 'Regenerative Medicine and Ionian Area—(DiMePRe-J), University of ' 'Bari “Aldo Moro”, Piazza Giulio Cesare n. 11, 70100 Bari, ' 'Italy'}]}, { 'given': 'Annalisa', 'family': 'Saracino', 'sequence': 'additional', 'affiliation': [ { 'name': 'Clinic of Infectious Diseases, Department of Precision and ' 'Regenerative Medicine and Ionian Area—(DiMePRe-J), University of ' 'Bari “Aldo Moro”, Piazza Giulio Cesare n. 11, 70100 Bari, ' 'Italy'}]}, { 'ORCID': 'http://orcid.org/0000-0002-4729-7548', 'authenticated-orcid': False, 'given': 'Sergio', 'family': 'Lo Caputo', 'sequence': 'additional', 'affiliation': [ { 'name': 'S.C. Malattie Infettive, Dipartimento di Medicina Clinica e ' 'Sperimentale, University of Foggia, 71100 Foggia, Italy'}]}, { 'ORCID': 'http://orcid.org/0000-0001-6099-2273', 'authenticated-orcid': False, 'given': 'Giordano', 'family': 'Madeddu', 'sequence': 'additional', 'affiliation': [ { 'name': 'Unit of Infectious Diseases, Department of Medicine, Surgery, ' 'and Pharmacy, University of Sassari, 07100 Sassari, Italy'}]}], 'member': '1968', 'published-online': {'date-parts': [[2023, 8, 17]]}, 'reference': [ { 'key': 'ref_1', 'doi-asserted-by': 'crossref', 'first-page': '221', 'DOI': '10.1080/22221751.2020.1719902', 'article-title': 'Genomic Characterization of the 2019 Novel Human-Pathogenic Coronavirus ' 'Isolated from a Patient with Atypical Pneumonia after Visiting Wuhan', 'volume': '9', 'author': 'Chan', 'year': '2020', 'journal-title': 'Emerg. 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