Change in Effectiveness of Sotrovimab for Preventing Hospitalization and Mortality for At-risk COVID-19 Outpatients During an Omicron BA.1 and BA.1.1-Predominant Phase
et al., International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.10.002, Jun 2022 (preprint)
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.
6,200+ studies for
200+ treatments. c19early.org
|
Retrospective 30,247 outpatients in the USA, showing no significant differences with sotrovimab with omicron BA.1.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.11-3, BA.4, BA.54, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.15, and no efficacy for BA.26, XBB, XBB.1.5, ХВВ.1.9.17, XBB.1.16, BQ.1.1.45, and CL.15. US EUA has been revoked.
Although the 38% lower mortality is not statistically significant, it is consistent with the significant 46% lower mortality [6‑69%] from meta analysis of the 14 mortality results to date.
Standard of Care (SOC) for COVID-19 in the study country,
the USA, is very poor with very low average efficacy for approved treatments8.
Only expensive, high-profit treatments were approved for early treatment. Low-cost treatments were excluded, reducing the probability of early treatment due to access and cost barriers, and eliminating complementary and synergistic benefits seen with many low-cost treatments.
|
risk of death, 38.0% lower, RR 0.62, p = 0.62, treatment 1 of 1,542 (0.1%), control 7 of 3,663 (0.2%), odds ratio converted to relative risk.
|
|
risk of hospitalization, 17.5% lower, RR 0.82, p = 0.32, treatment 39 of 1,542 (2.5%), control 116 of 3,663 (3.2%), NNT 157, odds ratio converted to relative risk, primary outcome.
|
|
risk of progression, 2.8% higher, RR 1.03, p = 0.83, treatment 93 of 1,542 (6.0%), control 224 of 3,663 (6.1%), NNT 1189, odds ratio converted to relative risk, ED visit.
|
| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
1.
Liu et al., Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2, bioRxiv, doi:10.1101/2021.12.14.472719.
2.
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.
3.
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.
4.
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.
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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.
6.
Zhou et al., SARS-CoV-2 Omicron BA.2 Variant Evades Neutralization by Therapeutic Monoclonal Antibodies, bioRxiv, doi:10.1101/2022.02.15.480166.
Aggarwal et al., 18 Jun 2022, retrospective, USA, peer-reviewed, 10 authors, study period 26 December, 2021 - 10 March, 2022.
Contact: neil.aggarwal@cuanschutz.edu.
Change in effectiveness of sotrovimab for preventing hospitalization and mortality for at-risk COVID-19 outpatients during an Omicron BA.1 and BA.1.1-predominant phase
International Journal of Infectious Diseases, doi:10.1016/j.ijid.2022.10.002
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Conflict of interest The authors do not have a commercial or other association that might pose a conflict of interest (e.g., pharmaceutical stock ownership, consultancy, advisory board membership, relevant patents, or research funding)
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