Trends, regional variation and clinical characteristics of recipients of antivirals and neutralising monoclonal antibodies

Trends, regional variation and clinical characteristics of recipients of antivirals and neutralising monoclonal antibodies for non-hospitalised COVID-19: a descriptive cohort study of 23.4 million people in OpenSAFELY

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How to cite: Trends, regional variation and clinical characteristics of recipients of antivirals and neutralising monoclonal antibodies for non-hospitalised COVID-19: a descriptive cohort study of 23.4 million people in OpenSAFELY The OpenSAFELY Collaborative, Amelia Green, Helen J Curtis, Rose Higgins, Rebecca Smith, Amir Mehrkar, Peter Inglesby, Viyaasan Mahalingasivam, Henry Drysdale, Nicholas J DeVito, Richard Croker, Christopher T Rentsch, Krishnan Bhaskaran, Colm Andrews, Seb Bacon, Simon Davy, Iain Dillingham, David Evans, Louis Fisher, George Hickman, Lisa Hopcroft, William J Hulme, Linda Nab, Jon Massey, Jessica Morley, Caroline E Morton, Robin Park, Alex J Walker, Tom Ward, Milan Wiedemann, Chris Bates, Jonathan Cockburn, John Parry, Frank Hester, Sam Harper, Ian J Douglas, Stephen JW Evans, Laurie Tomlinson, Brian MacKenna, Ben Goldacre medRxiv 2022.03.07.22272026; doi: https://doi.org/10.1101/2022.03.07.22272026

Abstract

Background: From December 16th 2021, antivirals and neutralising monoclonal antibodies (nMABs) were available to treat high-risk non-hospitalised patients with COVID-19 in England.

Aims: To develop a framework for detailed near real-time monitoring of treatment deployment, to ascertain eligibility status for patients and to describe trends and variation in coverage of treatment between geographic, clinical and demographic groups.

Methods: With the approval of NHS England we conducted a retrospective cohort study using routine clinical data from 23.4m people in the OpenSAFELY-TPP database, approximately 40% of England’s population. We implemented national eligibility criteria and generated descriptive statistics with detailed clinical, demographic and geographic breakdowns for patients receiving an antiviral or nMAB.

Results: We identified 50,730 non-hospitalised patients with COVID-19 between 11th December 2021 and 23rd February 2022 who were potentially eligible for antiviral and/or nMAB treatment. 6420 (15%) received treatment (sotrovimab 3600 (56%); molnupiravir 2680 (42%); nirmatrelvir/ritonavir (Paxlovid) 80 (1%); casirivimab 50 (1%); and remdesivir <5). The proportion treated varied by risk group, with the lowest proportion treated in those with liver disease (10%; 95% CI 9-11). Treatment type also varied, with molnupiravir favoured over sotrovimab in only two high risk cohorts: Down syndrome (67%; 95% CI 59-74) and HIV/AIDS (63%; 95% CI 56-70). The proportion treated varied by ethnicity, from White (14%; 95% CI 13-14) or Asian (13%; 95% CI 12-14) to Black (9%; 95% CI 8-11); by NHS Regions (from 6% (95% CI 5-6) in Yorkshire and the Humber to 17% (95% CI 16-18) in the East of England); and by rurality from 16% (95% CI 14-17) in “Rural - village and dispersed” to 10% (95% CI 10-11) in “Urban - conurbation”. There was also lower coverage among care home residents (4%; 95% CI 3-4), those with dementia (4%; 95% CI 3-5), those with sickle cell disease (7%; 95% CI 5-8), and in the most socioeconomically deprived areas (9%; 95% CI 8-9, vs least deprived: 15%; 95% CI 15-16). Patients who were housebound, or who had a severe mental illness had a slightly reduced chance of being treated (10%; 95% CI 8-11 and 10%; 95% CI 8-12, respectively). Unvaccinated patients were substantially less likely to receive treatment (5%; 95% CI 4-6).

Conclusions: Using the OpenSAFELY platform we have developed and delivered a rapid, near real-time data-monitoring framework for the roll-out of antivirals and nMABs in England that can deliver detailed coverage reports in fine-grained clinical and demographic risk groups, using publicly auditable methods, using linked but pseudonymised patient-level NHS data in a highly secure Trusted Research Environment. Targeted activity may be needed to address apparent lower treatment coverage observed among certain groups, in particular (at present): different NHS regions, socioeconomically deprived areas, and care homes