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0 0.5 1 1.5 2+ Mortality 81% Improvement Relative Risk Oxygen therapy 92% Sotrovimab  De Vito et al.  EARLY TREATMENT Is early treatment with sotrovimab beneficial for COVID-19? Retrospective 689 patients in Italy (January - December 2022) Lower mortality (p=0.00051) and lower oxygen therapy (p<0.0001) De Vito et al., Viruses, August 2023 Favors sotrovimab Favors control

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

De Vito et al., Viruses, doi:10.3390/v15081757
Aug 2023  
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Sotrovimab for COVID-19
39th treatment shown to reduce risk in May 2023
*, now known with p = 0.0017 from 22 studies, recognized in 37 countries. Efficacy is variant dependent.
Lower risk for hospitalization.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,000+ studies for 60+ treatments.
Retrospective 689 COVID-19 patients in Italy, showing lower mortality with sotrovimab treatment.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 Liu, Sheward, VanBlargan, BA.4, BA.5 Haars, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.1 Pochtovyi, and no efficacy for BA.2 Zhou, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.1 Pochtovyi. US EUA has been revoked.
risk of death, 81.1% lower, RR 0.19, p < 0.001, treatment 18 of 341 (5.3%), control 63 of 348 (18.1%), NNT 7.8, odds ratio converted to relative risk.
risk of oxygen therapy, 91.8% lower, RR 0.08, p < 0.001, treatment 17 of 341 (5.0%), control 144 of 348 (41.4%), NNT 2.7, odds ratio converted to relative risk.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
De Vito et al., 17 Aug 2023, retrospective, Italy, peer-reviewed, 12 authors, study period 1 January, 2022 - 31 December, 2022, average treatment delay 1.0 days. Contact: (corresponding author),,,,,,,
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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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