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
Author:
De Vito Andrea1ORCID, Colpani Agnese1ORCID, Poliseno Mariacristina2ORCID, Diella Lucia3, Ieva Francesco Rosario Paolo2, Belati Alessandra3, Papale Roberto2, Babudieri Sergio1ORCID, De Santis Laura3, Saracino Annalisa3, Lo Caputo Sergio2ORCID, Madeddu Giordano1ORCID
Affiliation:
1. Unit of Infectious Diseases, Department of Medicine, Surgery, and Pharmacy, University of Sassari, 07100 Sassari, Italy 2. S.C. Malattie Infettive, Dipartimento di Medicina Clinica e Sperimentale, University of Foggia, 71100 Foggia, Italy 3. 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
Abstract
(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 < 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.
Subject
Virology,Infectious Diseases
Reference46 articles.
1. Genomic Characterization of the 2019 Novel Human-Pathogenic Coronavirus Isolated from a Patient with Atypical Pneumonia after Visiting Wuhan;Chan;Emerg. Microbes Infect.,2020 2. SARS-CoV-2, SARS-CoV, and MERS-CoV Viral Load Dynamics, Duration of Viral Shedding, and Infectiousness: A Systematic Review and Meta-Analysis;Cevik;Lancet Microbe,2020 3. Comparison of Confirmed COVID-19 with SARS and MERS Cases—Clinical Characteristics, Laboratory Findings, Radiographic Signs and Outcomes: A Systematic Review and Meta-analysis;Pormohammad;Rev. Med. Virol.,2020 4. SARS-CoV-2 Pathogenesis;Lamers;Nat. Rev. Microbiol.,2022 5. Mittal, A., Manjunath, K., Ranjan, R.K., Kaushik, S., Kumar, S., and Verma, V. (2020). COVID-19 Pandemic: Insights into Structure, Function, and HACE2 Receptor Recognition by SARS-CoV-2. PLoS Pathog., 16.
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