STORRE
STORRE: Stirling Online Research Repository
http://hdl.handle.net/1893/36635| Appears in Collections: | Faculty of Health Sciences and Sport Journal Articles |
| Peer Review Status: | Refereed |
| Title: | Real-world severe COVID-19 outcomes associated with use of antivirals and neutralising monoclonal antibodies in Scotland |
| Author(s): | Tibble, Holly Mueller, Tanja Proud, Euan Hall, Elliott Kurdi, Amanj Robertson, Chris Bennie, Marion Woolford, Lana Laidlaw, Lynn Sterniczuk, Kamil Sheikh, Aziz |
| Contact Email: | elliott.hall@stir.ac.uk |
| Issue Date: | 28-Jun-2024 |
| Date Deposited: | 19-Dec-2024 |
| Citation: | Tibble H, Mueller T, Proud E, Hall E, Kurdi A, Robertson C, Bennie M, Woolford L, Laidlaw L, Sterniczuk K & Sheikh A (2024) Real-world severe COVID-19 outcomes associated with use of antivirals and neutralising monoclonal antibodies in Scotland. <i>npj Primary Care Respiratory Medicine</i>, 34, Art. No.: 17. https://doi.org/10.1038/s41533-024-00374-x |
| Abstract: | We sought to investigate the incidence of severe COVID-19 outcomes after treatment with antivirals and neutralising monoclonal antibodies, and estimate the comparative effectiveness of treatments in community-based individuals. We conducted a retrospective cohort study investigating clinical outcomes of hospitalisation, intensive care unit admission and death, in those treated with antivirals and monoclonal antibodies for COVID-19 in Scotland between December 2021 and September 2022. We compared the effect of various treatments on the risk of severe COVID-19 outcomes, stratified by most prevalent sub-lineage at that time, and controlling for comorbidities and other patient characteristics. We identified 14,365 individuals treated for COVID-19 during our study period, some of whom were treated for multiple infections. The incidence of severe COVID-19 outcomes (inpatient admission or death) in community-treated patients (81% of all treatment episodes) was 1.2% (n = 137/11894, 95% CI 1.0-1.4), compared to 32.8% in those treated in hospital for acute COVID-19 (re-admissions or death; n = 40/122, 95% CI 25.1-41.5). For community-treated patients, there was a lower risk of severe outcomes (inpatient admission or death) in younger patients, and in those who had received three or more COVID-19 vaccinations. During the period in which BA.2 was the most prevalent sub-lineage in the UK, sotrovimab was associated with a reduced treatment effect compared to nirmaltrelvir + ritonavir. However, since BA.5 has been the most prevalent sub-lineage in the UK, both sotrovimab and nirmaltrelvir + ritonavir were associated with similarly lower incidence of severe outcomes than molnupiravir. Around 1% of those treated for COVID-19 with antivirals or neutralising monoclonal antibodies required hospital admission. During the period in which BA.5 was the prevalent sub-lineages in the UK, molnupiravir was associated with the highest incidence of severe outcomes in community-treated patients. |
| DOI Link: | 10.1038/s41533-024-00374-x |
| Rights: | This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. |
| Licence URL(s): | http://creativecommons.org/licenses/by/4.0/ |
| File | Description | Size | Format | |
|---|---|---|---|---|
| Tibble et al. (2024) COVID Outcomes Antivirals.pdf | Fulltext - Published Version | 784.11 kB | Adobe PDF | View/Open |
Understanding Outcomes of COVID-19 Treatments including Antivirals and Antibodies across Scotland
What is it about?
**Background** In response to Covid-19 pandemic, a number of drugs have been introduced or used in different ways. These drugs include antivirals (virus fighting medicines) and neutralising monoclonal antibodies (laboratory made antibodies that mimic natural ones). Over the course of last two years UK guidelines for Covid-19 therapeutics have been updated on the basis of research results. We analysed, collected and linked data to describe clinical outcomes after treatment with the two types of drugs named above. Patients and the public have helped us with the design and interpretation of this study. **Methods and Datasets** This was a study which looked back and observed clinical outcomes of hospitalisation, Intensive Care Unit (ICU) admission and death in people treated for Covid-19 in Scotland. The data used in the study on drug exposure were linked to additional datasets: - The Scottish Morbidity Records inpatient dataset ([SMR01](https://www.ndc.scot.nhs.uk/Data-Dictionary/SMR-Datasets/SMR01-General-Acute-Inpatient-and-Day-Case/Summary-of-Rules/)) - Rapid Preliminary Inpatient Data ([RAPID](https://www.publichealthscotland.scot/services/system-watch/rapid-preliminary-inpatient-data-rapid-datamart/)) - [SICSAG](https://publichealthscotland.scot/publications/audit-of-critical-care-in-nhsscotland/audit-of-critical-care-in-nhsscotland-scottish-intensive-care-society-audit-group-6-september-2022/) episode-level ICU admissions data - National Records of Scotland ([NRS](https://www.nrscotland.gov.uk/statistics-and-data/statistics/statistics-by-theme/vital-events/deaths)) mortality records - SARS-CoV-2 testing data (from the [ECOSS](https://www.hps.scot.nhs.uk/data/our-role-in-national-surveillance/)) - Covid-19 vaccinations ([Turas Vaccination Management Tool](https://turasdashboard.nes.nhs.scot/accessibility/VaccinationManagement/) and GP records) - SARS-CoV-2 virus sequencing (combining qualitative and quantitative) data Comorbidities (presence of two or more illnesses) were estimated from data on: - In-hospital-conducted medical procedures (e.g. transplants and chemotherapy) - GP records - Primary care prescription data ([PIS](https://www.ndc.scot.nhs.uk/National-Datasets/data.asp?SubID=9)) In this study the drugs of interest were: molnupiravir, Paxlovid, remdesivir, sotrovimab, sarilumab and tocilizumab. Information on the prescription or administration of these drugs was provided directly from 13 of 14 Health Boards. Additional data was received by 6 Health Boards from the Hospital Prescribing and Medicines Administration System ([HEPMA](https://www.med.scot.nhs.uk/resources/resources/hepma)). **Study Outcomes** Clinical outcomes we analysed, included hospital and ICU admissions, and deaths (of any cause and Covid-19) within 28 days of starting treatment. The population groups involved in this study were assigned to 1 of 4 groups: - Group 1 – people hospitalised for acute Covid-19 - Group 2 – people who were in hospital for more than 2 weeks or with concurrent (at the same time) Covid-19 - Group 3 – people treated outside of a hospital - Group 4 – uncoded hospital patients who could not be classified as Group 1 or 2 Not all Covid-19 patients were eligible for treatment. Therefore, we did not compare clinical outcomes between the treated and untreated. Eligibility depended on those who had existing health conditions, medication taken and severity of Covid-19. **Results** There were 14,635 Covid-19 treatment events identified in datasets coming from Scotland. 80% of them were in the outpatient or community setting for non-severe Covid-19. 21.8% of those treated for acute Covid-19 in a hospital setting and released within 28 days of starting treatment were admitted again within 28 days. There were only 2.8% patients treated in hospital with hospital-onset or concurrent Covid-19. Of those people treated outside hospital, only 1.1% had an admission within 28 days. Group 3 patients who were treated with combination of therapies (likely to be the highest risk patients) had the highest chances of hospital admission or dying within 28 days of starting treatment. Factors such as having fewer than 3 Covid-19 vaccinations, a diagnosis of blood cancer or chronic kidney disease, taking immunosuppressants, previous chemotherapy or a solid organ transplant were all linked with higher odds of Covid-19 hospitalisation. During the period in which BA.5 has been the most predominant variant in the UK, sotrovimab was associated with the lowest risk of severe outcomes in Group 3 patients. **Conclusions and Limitations** The number of patients given each treatment type have changed over time. It is safe to assume that the characteristics of patients treated with each medication have changed in response to new guidelines and evidence. This study has its limitations. This includes exploring comparisons of clinical outcomes between different treatments may not identify differences in patient characteristics. For example severity, comorbidities and medications taken at the same time. Due to the lack of data on Covid-19 symptoms, we were unable to compare untreated patients. For instance, high-risk patients who did not show symptoms or those who refused treatment. As a result, we could not provide a strong and meaningful evaluation of improvement in clinical outcomes.
This item is protected by original copyright |
A file in this item is licensed under a Creative Commons License
Items in the Repository are protected by copyright, with all rights reserved, unless otherwise indicated.
The metadata of the records in the Repository are available under the CC0 public domain dedication: No Rights Reserved https://creativecommons.org/publicdomain/zero/1.0/
If you believe that any material held in STORRE infringes copyright, please contact library@stir.ac.uk providing details and we will remove the Work from public display in STORRE and investigate your claim.