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0 0.5 1 1.5 2+ Death/hospitalization 41% Improvement Relative Risk Paxlovid for COVID-19  Evans et al.  EARLY TREATMENT Is early treatment with paxlovid beneficial for COVID-19? Retrospective 5,575 patients in the United Kingdom (Dec 2021 - Apr 2022) Lower death/hosp. with paxlovid (p=0.037) c19early.org Evans et al., J. Infection, January 2023 Favors paxlovid Favors control

Real-world effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab on preventing hospital admission among higher-risk patients with COVID-19 in Wales: A retrospective cohort study

Evans et al., Journal of Infection, doi:10.1016/j.jinf.2023.02.012
Jan 2023  
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Retrospective high risk outpatients in the UK, showing lower hospitalization/death with paxlovid treatment. Residual confounding is likely with adjustments having no detail on specific comorbidities. Patients with contraindications for paxlovid were not excluded.
Confounding by contraindication. Hoertel et al. find that over 50% of patients that died had a contraindication for the use of Paxlovid Hoertel. Retrospective studies that do not exclude contraindicated patients may significantly overestimate efficacy.
Black box warning. The FDA notes that "severe, life-threatening, and/or fatal adverse reactions due to drug interactions have been reported in patients treated with paxlovid" FDA.
Study covers molnupiravir, sotrovimab, and paxlovid.
risk of death/hospitalization, 41.0% lower, HR 0.59, p = 0.04, treatment 602, control 4,973, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Evans et al., 25 Jan 2023, retrospective, United Kingdom, peer-reviewed, 11 authors, study period 16 December, 2021 - 22 April, 2022. Contact: andrew.evans@gov.wales, cathy.qi@swansea.ac.uk, j.o.adebayo@swansea.ac.uk, underwoodj7@cardiff.ac.uk, coulsonjm@cardiff.ac.uk, r.bailey@swansea.ac.uk, gareth.john@wales.nhs.uk, edwardsag@cardiff.ac.uk, coopera8@cardiff.ac.uk, r.a.lyons@swansea.ac.uk, a.akbari@swansea.ac.uk.
This PaperPaxlovidAll
Real-world effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab on preventing hospital admission among higher-risk patients with COVID-19 in Wales: A retrospective cohort study
Andrew Evans, Cathy Qi, Jubril Omololu Adebayo, Jonathan Underwood, James Coulson, Rowena Bailey, Ronan Lyons, Adrian Edwards, Alison Cooper, Gareth John, Ashley Akbari
Journal of Infection, doi:10.1016/j.jinf.2023.02.012
Objective: To compare the effectiveness of molnupiravir, nirmatrelvir-ritonavir, and sotrovimab with no treatment in preventing hospital admission or death in higher-risk patients infected with SARS-CoV-2 in the community. Design: Retrospective cohort study of non-hospitalized adult patients with COVID-19 using the Secure Anonymised Information Linkage (SAIL) Databank. Setting: A real-world cohort study was conducted within the SAIL Databank (a secure trusted research environment containing anonymised, individual, population-scale electronic health record (EHR) data) for the population of Wales, UK. Participants: Adult patients with COVID-19 in the community, at higher risk of hospitalization and death, testing positive for SARS-CoV-2 between 16th December 2021 and 22nd April 2022. Interventions: Molnupiravir, nirmatrelvir-ritonavir, and sotrovimab given in the community by local health boards and the National Antiviral Service in Wales. Main outcome measures: All-cause admission to hospital or death within 28 days of a positive test for SARS-CoV-2. Statistical analysis: Cox proportional hazard model with treatment status (treated/untreated) as a timedependent covariate and adjusted for age, sex, number of comorbidities, Welsh Index of Multiple Deprivation, and vaccination status. Secondary subgroup analyses were by treatment type, number of comorbidities, and before and on or after 20th February 2022, when omicron BA.1 and omicron BA.2 were the dominant subvariants in Wales. Results: Between 16th December 2021 and 22nd April 2022, 7013 higher-risk patients were eligible for inclusion in the study. Of these, 2040 received treatment with molnupiravir (359, 17.6%), nirmatrelvir-ritonavir (602, 29.5%), or sotrovimab (1079, 52.9%). Patients in the treatment group were younger (mean age 53 vs 57 years), had fewer comorbidities, and a higher proportion had received four or more doses of the COVID-19 vaccine (36.3% vs 17.6%). Within 28 days of a positive test, 628 (9.0%) patients were admitted to hospital or died (84 treated and 544 untreated). The primary analysis indicated a lower risk of hospitalization or death at any point within 28 days in treated participants compared to those not receiving treatment. The adjusted hazard rate was 35% (95% CI: 18-49%) lower in treated than untreated participants. There was no indication of the superiority of one treatment over another and no evidence of a reduction in Journal of Infection xxx (xxxx) xxx-xxx
Ethics approval This project uses anonymised individual-level data sources held within the Trusted Research Environment provided by the SAIL Databank at Swansea University, Swansea, UK. All proposals to use SAIL data are subject to review by the independent Information Governance Review Panel (IGRP). This work was approved under proposal number 0911 after careful considerations by IGRP Panel. Access to data is gained through a privacy-protecting safe haven and remote access system referred to as the SAIL Gateway. CRediT authorship contribution statement All authors were involved in the Conceptualization and design of the study. AE, GJ, AA, CQ, LA and RB contributed to the acquisition of data. CQ, LA and RB carried out the statistical analysis. AE, CQ and LA drafted the original version of the manuscript. All authors contributed to the interpretation of the results and critical revision of the manuscript. All authors approved the final manuscript. AE is the guarantor for this study. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. Reporting We used the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) checklist to guide our transparent reporting of our work. A completed STROBE Statement -Checklist of items that should be included in reports of cohort studies is provided. Appendix A. Supplementary material Supplementary data associated with this article..
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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