Effectiveness of Sotrovimab and Molnupiravir in community settings in England across the Omicron BA.1 and BA.2 sublineages: emulated target trials using the OpenSAFELY platform

Tazare et al., medRxiv, doi:10.1101/2023.05.12.23289914 (Preprint)

Tazare et al., Effectiveness of Sotrovimab and Molnupiravir in community settings in England across the Omicron BA.1 and BA.2.., medRxiv, doi:10.1101/2023.05.12.23289914 (Preprint)

May 2023 Source PDF

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OpenSAFELY retrospective 75,048 outpatients in the UK, using the clone-censor-weight approach to address immortal time bias, showing lower combined mortality/hospitalization with sotrovimab treatment.

Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 [Liu, Sheward, VanBlargan] and a lack of efficacy for BA.2 [Zhou]. US EUA has been revoked.

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

2. Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354, Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron), https://www.biorxiv.org/content/10.1101/2021.12.19.473354.

3. VanBlargan et al., bioRxiv, doi:10.1101/2021.12.15.472828, An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies, https://www.biorxiv.org/content/10.1101/2021.12.15.472828v1.

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

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This study includes molnupiravir and sotrovimab.

risk of death/hospitalization, 16.0% lower, HR 0.84, p = 0.002, treatment 6,408, control 65,568.

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

Tazare et al., 16 May 2023, retrospective, United Kingdom, preprint, 31 authors, study period 16 December, 2021 - 21 May, 2022.

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