Real world Effectiveness of Sotrovimab in Preventing COVID-19–related Hospitalisation or Death in Patients Infected with Omicron BA.2
Alwaleed Behzad, Aamal Mohamed, Ahmed Ali, Sara Niinuma, Alexandra E Butler, Manaf Alqahtani
Journal of Infection and Public Health, doi:10.1016/j.jiph.2023.11.029
Background. Laboratory-based evidence indicates that neutralization of the BA.2 (Omicron) variant by sotrovimab is reduced versus previous SARS-CoV-2 variants. Since there is a lack of real-world data, we investigated whether sotrovimab has reduced clinical efficacy against the BA.2 variant. Methods. We performed a prospective cohort study using real-world data from 1180 randomlyselected BA.2 variant-infected patients. Follow-up to study endpoints averaged 29 days. For mild cases (not requiring oxygen-supplementation), primary outcomes were requiring O2supplementation, intensive care unit (ICU) admission or death. For moderate-to-severe COVID-19 cases (requiring oxygen-supplementation other than mechanical ventilation), the primary outcome was ICU admission or death. Results. Patients in the sotrovimab group (n=569) and control patients (n=611) were included. Sotrovimab-treated patients versus controls had reduced risk of death (0.4% vs 6.4%, p<0.001), need for oxygen supplementation (3.5% vs 12.8%, p<0.001) and ICU admission (0.2% vs 4.9%, p<0.001). The adjusted-odds ratio for developing any of these outcomes was 0.090 (95% CI 0.049-0.165, p<0.001). Subgroup analysis of moderate-to-severe sotrovimab-treated patients versus controls revealed reduced mortality (17.7% vs 37.2%, p=0.006) and ICU admission (0.0% vs 37.2%, p<0.001). Adjusted-hazards ratio for death or ICU admission was 0.256 (95% CI 0.111-0.593, p<0.001).
Conclusion. Sotrovimab was effective in reducing COVID-19 progression risk in high-risk BA.2 variant-infected patients. This finding may alleviate concerns about its clinical efficacy.
Ethics approval and consent to participate: The study was approved by the National COVID-19 Research Committee and the Bahrain Defence Force Hospital Ethics committee (Study code: CRT-COVID2022-155, approved on January 24, 2022). The study was conducted according to the Declaration of Helsinki, the International Conference on Harmonization Good Clinical Practices guidelines (ICH-GCP E6) and local regulations. All patients enrolled in the study provided written informed consent. Consent for publication: All authors gave their consent for publication.
Conflict of interest: None of the authors have any conflict of interest to declare.
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. a Mortality is significantly higher in the moderate-to-severe cases as compared to controls. b Oxygen supplementation was significantly lower in the moderate-to-severe cases as compared to control. c ICU admission was significantly lower in the moderate-to-severe cases as compared to control. d Main outcome of any of the three above was not significantly different between the moderate-to-severe cases and the control. *Significant difference at the level of p<0.05. J o u r n a l P r e -p r o o f
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