Overview

This OpenSAFELY report has been developed to support monitoring the ongoing roll-out of antivirals and neutralising monoclonal antibodies (nMABs) for the treatment of COVID-19, based on the population of 25.1m people registered with practices that use TPP SystmOne software. Since January 2022 this report has been updated several times to include new data. Consequently, there are likely to be small changes between some versions.

Between December 2021 and June 2023 the delivery of antivirals and nMABS was undertaken in COVID-19 Medicine Delivery Units (CMDUs). The COVID-19 therapeutics dataset captured information about COVID-19 treatments during this period, and is utilised in the generation of this reports. The final publication of that dataset included data up to the end of June 2023. Therefore, the reporting below covers the period December 2021 to June 2023.

Note that currently the clinician-assigned risk group for patients receiving Paxlovid or Remdesivir is not available. While we’re able to assign high risk groups to about 70% of these patients by implementing the NHS Digital logic, the other 30% are most likely identified via non-digital routes. For now, where results are broken down by high risk cohort and no high risk cohort is able to assigned, these patients are excluded.

The code and data for this report can be found in the OpenSAFELY antibody-and-antiviral-deployment repository. The accompanying manuscript is published in BMJ Medicine doi:10.1136/bmjmed-2022-000276.

Update: The release date of this report can be found at the top. If you have any questions about this report please contact team@opensafely.org.

Introduction

While vaccines remain the best strategy to prevent COVID-19, evidence suggests neutralising monoclonal antibodies (nMABs) or antivirals could potentially benefit certain vulnerable populations before or after exposure to SARS-CoV-2, such as the unvaccinated or recently vaccinated high-risk patients. On 11th December 2021, COVID-19 Medicine Delivery Units (CMDUs) were launched across England, offering antiviral medicines and neutralising monoclonal antibodies (nMABs) as treatment to patients with COVID-19 at high risk of severe outcomes in outpatient clinics or their own home.

With the roll-out of nMABs and antivirals, there is a need to assess the coverage of these new treatments amongst these patients, such as factors of relevance in determining nMAB and antiviral treatment and the impact of nMAB and antiviral treatment in the community and hospital settings.

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.

Full methods in code form can be found in the accompanying antibody-and-antiviral-deployment repository and are also described in our paper doi:10.1136/bmjmed-2022-000276. Brief methods can be found at the end of this report.

Results

Overall coverage of COVID-19 treatment

Between 11-Dec-2021 and 30-Jun-2023, a total of 169,980 non-hospitalised patients registered at a TPP practice in England were identified as potentially being eligible for receiving an antiviral or nMAB for treating COVID-19. Of the 169,980 potentially eligible patients, (17%) were classified into more than one high risk cohort (high risk cohort count range 1 - 7). The number of patients potentially eligible in each high risk cohort is described in Figure 1 and Table 1 below.

Of the 169,980 potentially eligible patients, 47,660 (28%) received treatment from a CMDU (Table 1, Figure 2);

• Paxlovid: 18,830;
• Sotrovimab: 17,420;
• Remdesivir: 210;
• Molnupiravir: 11,150;
• Casirivimab: 50.

Figure 1 Cumulative total of potentially eligible patients for receiving an antiviral or nMABs for treating COVID-19 since 11th December 2021, stratified by high risk cohort. Patients are considered eligible on the date of their positive SARS-CoV-2 test. Note, patients can appear in more than one high risk group, and the overall number in each group is likely to be an overestimation due to including SARS-CoV-2 infection confirmed by either lateral flow or PCR test (where only PCR-confirmed infections should have been treated according to guidance in effect prior to 10th February 2022), and potentially including non-symptomatic patients.

Figure 2 Cumulative total of patients who received an antiviral or nMAB for treating COVID-19 since 11th December 2021, stratified by (a) treatment type and (b) high risk cohorts. Shorter lines for Paxlovid and casirivimab reflect availability and guidance. Note, treated patients can appear in more than one high risk group.

Table 1 Count and proportion of potentially eligible patients in OpenSAFELY-TPP who have received treatment for COVID-19 since 11th December 2021, broken down by high risk cohort and treatment type. Patient counts of 0-7 are shown as <8 with remaining counts rounded to the nearest 10; as a result percentages may not add up to 100%

High risk patient cohorts

The proportion of potentially eligible patients receiving treatment varied over time and by high risk cohort (Figure 3).

Figure 3 Weekly proportion of eligible patients receiving an antiviral or nMAB for treating COVID-19 since 11th December 2021, stratified by high risk cohort. Proportions are rounded to 2 decimal places.

Key demographic and clinical characteristics of treated patients

Table 2 shows the count and proportion of potentially eligible patients who received treatment for COVID-19 by 30-Jun-2023, broken down by demographic and clinical categories and by treatment type. The proportion treated varied by ethnicity, NHS Regions and by rurality. There was also lower coverage among care home residents, those with dementia, those with sickle cell disease, unvaccinated patients and in the most socioeconomically deprived areas. Patients who were housebound, or who had a severe mental illness also had a slightly reduced chance of being treated.

Table 2 Count and proportion of potentially eligible patients in OpenSAFELY-TPP who have received treatment for COVID-19 since 11th December 2021, broken down by demographic and clinical categories and by treatment type. Patient counts of 0-7 are shown as <8 with remaining counts rounded to the nearest 10; as a result percentages may not add up to 100%.