RT Journal Article
SR Electronic
T1 Trends, variation, and clinical characteristics of recipients of antiviral drugs and neutralising monoclonal antibodies for covid-19 in community settings: retrospective, descriptive cohort study of 23.4 million people in OpenSAFELY
JF BMJ Medicine
JO bmjmed
FD BMJ Publishing Group Ltd
SP e000276
DO 10.1136/bmjmed-2022-000276
VO 2
IS 1
A1 Amelia C A Green
A1 Helen J Curtis
A1 Rose Higgins
A1 Linda Nab
A1 Viyaasan Mahalingasivam
A1 Rebecca M Smith
A1 Amir Mehrkar
A1 Peter Inglesby
A1 Henry Drysdale
A1 Nicholas J DeVito
A1 Richard Croker
A1 Christopher T Rentsch
A1 Krishnan Bhaskaran
A1 John Tazare
A1 Bang Zheng
A1 Colm D Andrews
A1 Sebastian C J Bacon
A1 Simon Davy
A1 Iain Dillingham
A1 David Evans
A1 Louis Fisher
A1 George Hickman
A1 Lisa E M Hopcroft
A1 William J Hulme
A1 Jon Massey
A1 Orla MacDonald
A1 Jessica Morley
A1 Caroline E Morton
A1 Robin Y Park
A1 Alex J Walker
A1 Tom Ward
A1 Milan Wiedemann
A1 Christopher Bates
A1 Jonathan Cockburn
A1 John Parry
A1 Frank Hester
A1 Sam Harper
A1 Ian J Douglas
A1 Stephen J W Evans
A1 Ben Goldacre
A1 Laurie A Tomlinson
A1 Brian MacKenna
YR 2023
UL http://bmjmedicine.bmj.com/content/2/1/e000276.abstract
AB Objective To ascertain patient eligibility status and describe coverage of antiviral drugs and neutralising monoclonal antibodies (nMAB) as treatment for covid-19 in community settings in England.Design Retrospective, descriptive cohort study, approved by NHS England.Setting Routine clinical data from 23.4 million people linked to data on covid-19 infection and treatment, within the OpenSAFELY-TPP database.Participants Outpatients with covid-19 at high risk of severe outcomes.Interventions Nirmatrelvir/ritonavir (paxlovid), sotrovimab, molnupiravir, casirivimab/imdevimab, or remdesivir, used in the community by covid-19 medicine delivery units.Results 93 870 outpatients with covid-19 were identified between 11 December 2021 and 28 April 2022 to be at high risk of severe outcomes and therefore potentially eligible for antiviral or nMAB treatment (or both). Of these patients, 19 040 (20%) received treatment (sotrovimab, 9660 (51%); molnupiravir, 4620 (24%); paxlovid, 4680 (25%); casirivimab/imdevimab, 50 (<1%); and remdesivir, 30 (<1%)). The proportion of patients treated increased from 9% (190/2220) in the first week of treatment availability to 29% (460/1600) in the latest week. The proportion treated varied by high risk group, being lowest in those with liver disease (16%; 95% confidence interval 15% to 17%); by treatment type, with sotrovimab favoured over molnupiravir and paxlovid in all but three high risk groups (Down's syndrome (35%; 30% to 39%), rare neurological conditions (45%; 43% to 47%), and immune deficiencies (48%; 47% to 50%)); by age, ranging from ≥80 years (13%; 12% to 14%) to 50-59 years (23%; 22% to 23%); by ethnic group, ranging from black (11%; 10% to 12%) to white (21%; 21% to 21%); by NHS region, ranging from 13% (12% to 14%) in Yorkshire and the Humber to 25% (24% to 25%) in the East of England); and by deprivation level, ranging from 15% (14% to 15%) in the most deprived areas to 23% (23% to 24%) in the least deprived areas. Groups that also had lower coverage included unvaccinated patients (7%; 6% to 9%), those with dementia (6%; 5% to 7%), and care home residents (6%; 6% to 7%).Conclusions Using the OpenSAFELY platform, we were able to identify patients with covid-19 at high risk of severe outcomes who were potentially eligible to receive treatment and assess the coverage of these new treatments among these patients. In the context of a rapid deployment of a new service, the NHS analytical code used to determine eligibility could have been over-inclusive and some of the eligibility criteria not fully captured in healthcare data. However targeted activity might be needed to resolve apparent lower treatment coverage observed among certain groups, in particular (at present): different NHS regions, ethnic groups, people aged ≥80 years, those living in socioeconomically deprived areas, and care home residents.Data may be obtained from a third party and are not publicly available. Access to the underlying identifiable and potentially re-identifiable pseudonymised electronic health record data is tightly governed by various legislative and regulatory frameworks, and restricted by best practice. The data in OpenSAFELY are drawn from general practice data across England where TPP is the data processor. TPP developers (CB, JC, and SH) initiate an automated process to create pseudonymised records in the core OpenSAFELY database, which are copies of key structured data tables in the identifiable records. These are linked onto key external data resources that have also been pseudonymised via SHA-512 one-way hashing of NHS numbers using a shared salt. Bennett Institute for Applied Data Science developers and principal investigators (BG, CEM, SCJB, AJW, WJH, HJC, DE, PI, SD, GH, RMS, ID, TW, JM, MW, RYP, KB and CTR) holding contracts with NHS England have access to the OpenSAFELY pseudonymised data tables as needed to develop the OpenSAFELY tools. These tools in turn enable researchers with OpenSAFELY Data Access Agreements to write and execute code for data management and data analysis without direct access to the underlying raw pseudonymised patient data, and to review the outputs of this code. All code for the full data management pipeline—from raw data to completed results for this analysis—and for the OpenSAFELY platform as a whole is available for review at github.com/OpenSAFELY.