Real world Effectiveness of Sotrovimab in Preventing COVID-19–related Hospitalisation or Death in Patients Infected with Omicron BA.2
et al., Journal of Infection and Public Health, doi:10.1016/j.jiph.2023.11.029, Dec 2023
Sotrovimab for COVID-19
44th treatment shown to reduce risk in
August 2022, now with p = 0.00054 from 28 studies, recognized in 42 countries.
Efficacy is variant dependent.
No treatment is 100% effective. Protocols
combine treatments.
6,300+ studies for
210+ treatments. c19early.org
|
Analysis of 1,180 high-risk COVID-19 outpatients infected with Omicron BA.2 showing lower risk of death or ICU admission with sotrovimab treatment.
Confounding by treatment propensity. This study analyzes a population
where only a fraction of eligible patients received the treatment. Patients
receiving treatment may be more likely to follow other recommendations, more
likely to receive additional care, and more likely to use additional
treatments that are not tracked in the data (e.g., nasal/oral hygiene1,2, vitamin D3, etc.) — either because the physician
recommending sotrovimab also recommended them, or
because the patient seeking out sotrovimab is more
likely to be familiar with the efficacy of additional treatments and more
likely to take the time to use them.
Therefore, these kind of studies may
overestimate the efficacy of treatments.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.14-6, BA.4, BA.57, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.18, and no efficacy for BA.29, XBB, XBB.1.5, ХВВ.1.9.110, XBB.1.16, BQ.1.1.45, and CL.18. US EUA has been revoked.
|
risk of death/ICU, 74.4% lower, HR 0.26, p = 0.001, treatment 569, control 611.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
4.
Liu et al., Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2, bioRxiv, doi:10.1101/2021.12.14.472719.
5.
Sheward et al., Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron), bioRxiv, doi:10.1101/2021.12.19.473354.
6.
VanBlargan et al., An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies, bioRxiv, doi:10.1101/2021.12.15.472828.
7.
Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.
8.
Pochtovyi et al., In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1, Vaccines, doi:10.3390/vaccines11101533.
Behzad et al., 4 Dec 2023, retrospective, Bahrain, peer-reviewed, 6 authors, study period 1 January, 2022 - 31 March, 2022.
Contact: mqahtani@rcsi-mub.com, dr.abehzad@gmail.com, dr.aamalmohamed@gmail.com, 19202638@rcsi-mub.com, 20202566@rcsi.com, abutler@rcsi.com.
Real world Effectiveness of Sotrovimab in Preventing COVID-19–related Hospitalisation or Death in Patients Infected with Omicron BA.2
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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