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Clinical Efficacy of the Neutralizing Antibody Therapy Sotrovimab in Patients with SARS-CoV-2 Omicron BA.1 and BA.2 Subvariant Infections

Miyashita et al., Viruses, doi:10.3390/v15061300

May 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.

4,000+ studies for 60+ treatments. c19early.org

Retrospective 844 patients treated with sotrovimab and matched controls in Japan, showing lower risk of oxygen therapy with 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 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 US EUA has been revoked.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.

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risk of mechanical ventilation, 60.0% lower, RR 0.40, p = 0.45, treatment 2 of 844 (0.2%), control 5 of 844 (0.6%), NNT 281, all.

risk of mechanical ventilation, 33.3% lower, RR 0.67, p = 1.00, treatment 2 of 642 (0.3%), control 3 of 642 (0.5%), NNT 642, BA.1.

risk of mechanical ventilation, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 202 (0.0%), control 2 of 202 (1.0%), NNT 101, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), BA.2.

risk of oxygen therapy, 55.3% lower, RR 0.45, p < 0.001, treatment 34 of 844 (4.0%), control 76 of 844 (9.0%), NNT 20, all.

risk of oxygen therapy, 53.6% lower, RR 0.46, p < 0.001, treatment 26 of 642 (4.0%), control 56 of 642 (8.7%), NNT 21, BA.1.

risk of oxygen therapy, 60.0% lower, RR 0.40, p = 0.03, treatment 8 of 202 (4.0%), control 20 of 202 (9.9%), NNT 17, BA.2.

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

Miyashita et al., 31 May 2023, retrospective, Japan, peer-reviewed, 7 authors, study period December 2021 - July 2022. Contact: miyashin@hirakata.kmu.ac.jp (corresponding author), ogatam@hirakata.kmu.ac.jp, fukudana@hirakata.kmu.ac.jp, yamuraak@hirakata.kmu.ac.jp, itot@hirakata.kmu.ac.jp, 99nakamori@gmail.com, ishiuray@takii.kmu.ac.jp.

This Paper Sotrovimab All

Clinical Efficacy of the Neutralizing Antibody Therapy Sotrovimab in Patients with SARS-CoV-2 Omicron BA.1 and BA.2 Subvariant Infections

Naoyuki Miyashita, Yasushi Nakamori, Makoto Ogata, Naoki Fukuda, Akihisa Yamura, Yoshihisa Ishiura, Tomoki Ito

Viruses, doi:10.3390/v15061300

Sotrovimab, an antibody active against severe acute respiratory syndrome coronavirus 2 that neutralizes antibodies, reduced the risk of COVID-19-related hospitalization or death in studies conducted before the emergence of the Omicron variant. The objective of this study is to evaluate the clinical efficacy of sotrovimab in patients with mild to moderate COVID-19 Omicron BA.1 and BA.2 subvariant infections using a propensity score matching method. The propensity score-matched cohort study population was derived from patients who received sotrovimab. We derived a comparator group from an age-and sex-matched population who were recuperating in a medical facility after COVID-19 infection or from elderly person entrance facilities during the same period who were eligible for but did not receive sotrovimab treatment. In total, 642 patients in the BA.1 subvariant group and 202 in the BA.2 subvariant group and matched individuals were analyzed. The outcome was the requirement for oxygen therapy. In the treatment group, 26 patients with the BA.1 subvariant and 8 patients with the BA.2 subvariant received oxygen therapy. The administration of oxygen therapy was significantly lower in the treatment group than in the control group (BA.1 subvariant group, 4.0% vs. 8.7%, p = 0.0008; BA.2 subvariant group, 4.0% vs. 9.9%, p = 0.0296). All these patients were admitted to our hospitals and received additional therapy and then recovered. No deaths were observed in either group. Our results demonstrate that the sotrovimab antibody treatment may be associated with a reduction in the requirement for oxygen therapy among high-risk patients with mild to moderate COVID-19 Omicron BA.1 and BA.2 subvariants.

Author Contributions: All the authors conceived the study, participated in its design and coordination, and collected and managed data, including quality control. N.M. and Y.N. drafted the manuscript, and all authors contributed substantially to its revision. All authors have read and agreed to the published version of the manuscript. Funding: This research received no external funding. Institutional Review Board Statement: The study was conducted in accordance with the Declaration of Helsinki, and approved by the Ethics Committee at Kansai Medical University and all participating facilities (protocol code 2020319 and 24 August 2021). Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.

References

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