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Comparative effectiveness of sotrovimab versus no treatment in non-hospitalised high-risk COVID-19 patients in north west London: a retrospective cohort study

Drysdale et al., BMJ Open Respiratory Research, doi:10.1136/bmjresp-2023-002238

Jul 2023

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Sotrovimab for COVID-19

38th 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.

4,100+ studies for 60+ treatments. c19early.org

Retrospective 599 high-risk sotrovimab patients and 5,191 untreated controls, showing lower hospitalization/mortality with treatment, without statistical significance in the overall cohort. Efficacy was better for those ≥65, and efficacy was lower in later time periods.

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 hygiene c19early.org, c19early.org (B), vitamin D c19early.org (C), 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.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 US EUA has been revoked.

1. c19early.org, c19early.org/p.c19early.org/p.

2. c19early.org (B), c19early.org/ph.c19early.org/ph.

3. c19early.org (C), c19early.org/d.c19early.org/d.

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.mdpi.com, doi.org.

5. Liu et al., Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2, bioRxiv, doi:10.1101/2021.12.14.472719.biorxiv.org, doi.org.

6. 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.mdpi.com, doi.org.

7. 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.biorxiv.org, doi.org.

8. 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.biorxiv.org, doi.org.

9. Zhou et al., SARS-CoV-2 Omicron BA.2 Variant Evades Neutralization by Therapeutic Monoclonal Antibodies, bioRxiv, doi:10.1101/2022.02.15.480166.biorxiv.org, doi.org.

Important missing comments or errors? Let us know.

risk of death, 29.0% lower, HR 0.71, p = 0.65, treatment 599, control 5,191, propensity score weighting, Cox proportional hazards.

risk of death, 45.0% lower, HR 0.55, p = 0.55, ≥65 years old, propensity score weighting, Cox proportional hazards.

risk of death, 98.0% higher, HR 1.98, p = 0.55, <65 years old, propensity score weighting, Cox proportional hazards.

risk of death, 41.0% lower, HR 0.59, p = 0.62, period 2, propensity score weighting, Cox proportional hazards.

risk of death, 4.0% higher, HR 1.04, p = 0.97, period 3, propensity score weighting, Cox proportional hazards.

risk of death/hospitalization, 50.0% lower, HR 0.50, p = 0.07, treatment 599, control 5,191, propensity score weighting, Cox proportional hazards.

risk of hospitalization, 57.0% lower, HR 0.43, p = 0.05, treatment 599, control 5,191, propensity score weighting, Cox proportional hazards.

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Drysdale et al., 27 Jul 2023, retrospective, United Kingdom, peer-reviewed, 14 authors, study period August 2020 - March 2021. Contact: myriam.g.drysdale@gsk.com.

This Paper Sotrovimab All

Comparative effectiveness of sotrovimab versus no treatment in non-hospitalised high-risk COVID-19 patients in north west London: a retrospective cohort study

Dr Myriam Drysdale, Evgeniy R Galimov, Marcus James Yarwood, Vishal Patel, Bethany Levick, Daniel C Gibbons, Jonathan D Watkins, Sophie Young, Benjamin F Pierce, Emily J Lloyd, William Kerr, Helen J Birch, Tahereh Kamalati, Stephen J Brett

BMJ Open Respiratory Research, doi:10.1136/bmjresp-2023-002238

Background We assessed the effectiveness of sotrovimab vs no early COVID-19 treatment in highest-risk COVID-19 patients during Omicron predominance. Methods Retrospective cohort study using the Discover dataset in North West London. Included patients were nonhospitalised, aged ≥12 years and met ≥1 National Health Service highest-risk criterion for sotrovimab treatment. We used Cox proportional hazards models to compare HRs of 28-day COVID-19-related hospitalisation/death between highest-risk sotrovimab-treated and untreated patients. Age, renal disease and Omicron subvariant subgroup analyses were performed. Results We included 599 sotrovimab-treated patients and 5191 untreated patients. Compared with untreated patients, the risk of COVID-19 hospitalisation/death (HR 0.50, 95% CI 0.24, 1.06; p=0.07) and the risk of COVID-19 hospitalisation (HR 0.43, 95% CI 0.18, 1.00; p=0.051) were both lower in the sotrovimab-treated group; however, statistical significance was not reached. In the ≥65 years and renal disease subgroups, sotrovimab was associated with a significantly reduced risk of COVID-19 hospitalisation, by 89% (HR 0.11, 95% CI 0.02, 0.82; p=0.03) and 82% (HR 0.18, 95% CI 0.05, 0.62; p=0.007), respectively. Conclusions Risk of COVID-19 hospitalisation in sotrovimab-treated patients aged ≥65 years and with renal disease was significantly lower compared with untreated patients. Overall, risk of hospitalisation was also lower for sotrovimab-treated patients, but statistical significance was not reached. ⇒ This study begins to fill the evidence gap in relation to early treatments for mild-to-moderate COVID-19, particularly their effectiveness against disease caused by Omicron variants to date. on April 14,

Contributors MD, MJY, VP, BL, DCG, JDW, SY, BFP, HJB, TK and SJB designed the study; ERG performed inverse probability of treatment weighted survival analysis; MJY performed descriptive analysis; MD, ERG, MJY, BL, DCG, JDW, SY, BFP, EJL, WK, TK and SJB interpreted results. MD is responsible for the overall content as the guarantor. All authors took part in drafting, revising or critically reviewing the manuscript; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work. Competing interests MD, DCG, EJL, WK and HJB are employees of, and/or shareholders in, GSK. VP was an employee of GSK at the time of the study and is now an employee of KVM Analytics. ERG, MJY, JDW, SY, BFP and TK are (or were at time of study) employees of Imperial College Health Partners, which received funding from GSK and Vir Biotechnology to conduct the study. BL is an employee of OPEN Health, which received funding from GSK and Vir Biotechnology, Inc, to conduct the study. A consultancy fee was paid to SJB's institutional account. Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. Patient consent for publication Not applicable. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement Data are available upon reasonable request. The..

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