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
Andrea De Vito, Agnese Colpani, Mariacristina Poliseno, Lucia Diella, Francesco Rosario Paolo Ieva, Alessandra Belati, Roberto Papale, Sergio Babudieri, Laura De Santis, Annalisa Saracino, Sergio Lo Caputo, Giordano Madeddu
Viruses, doi:10.3390/v15081757
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 )], 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 )] and those with dyspnea at diagnosis [OR 3.63 (95%CI 2.02-6.50)] had an increased risk of death. In contrast, vaccination ] 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.
Conflicts of Interest: G.M. has been advisor for Gilead Sciences, ViiV, and MSD and has received speakers' honoraria from Gilead Sciences, ViiV, MSD, and GSK. A.S. has been advisor for Gilead Sciences, ViiV, Janssen, Astrazeneca, GSK, and MSD and has received speakers' honoraria from Gilead Sciences, ViiV, M.S.D., Janssen, Astrazeneca, and GSK. S.L.C. has been advisor for Gilead Sciences and GSK and has received speakers' honoraria from Gilead Sciences and GSK. The other authors declare no conflict of interest.
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'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 < 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 '
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