Comparative effectiveness of Paxlovid versus sotrovimab and molnupiravir for preventing severe COVID-19 outcomes in non-hospitalised patients: observational cohort study using the OpenSAFELY platform
Zheng et al.,
Comparative effectiveness of Paxlovid versus sotrovimab and molnupiravir for preventing severe COVID-19..,
medRxiv, doi:10.1101/2023.01.20.23284849 (Preprint)
OpenSAFELY retrospective 7,683 outpatients in the UK, showing no significant difference in hospitalization/death between paxlovid and sotrovimab.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 [Liu, Sheward, VanBlargan] and a lack of efficacy for BA.2 [Zhou]. US EUA has been revoked.
This study is excluded in the after exclusion results of meta
analysis:
study compares against another treatment showing significant efficacy.
risk of death/hospitalization, 3.8% lower, HR 0.96, p = 0.91, treatment 2,847, control 4,836, inverted to make HR<1 favor treatment, COVID-19 related, propensity score weighting, Cox proportional hazards, day 60, model 4.
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risk of death/hospitalization, 13.6% higher, HR 1.14, p = 0.70, treatment 19 of 2,847 (0.7%), control 33 of 4,836 (0.7%), inverted to make HR<1 favor treatment, COVID-19 related, propensity score weighting, Cox proportional hazards, day 28, model 4.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Zheng et al., 22 Jan 2023, retrospective, United Kingdom, preprint, mean age 54.3, 9 authors, study period 11 February, 2022 - 1 October, 2022, this trial compares with another treatment - results may be better when compared to placebo.
Contact:
laurie.tomlinson@lshtm.ac.uk.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2023.01.20.23284849; this version posted January 22, 2023. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY 4.0 International license .
Comparative effectiveness of Paxlovid versus sotrovimab and
molnupiravir for preventing severe COVID-19 outcomes in nonhospitalised patients: observational cohort study using the
OpenSAFELY platform
Bang Zheng1, John Tazare1, Linda Nab2, Amir Mehrkar2, Brian MacKenna2, Ben Goldacre2, Ian
J Douglas1, Laurie A Tomlinson1, on behalf of The OpenSAFELY Collaborative
1
London School of Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT, UK
2
The DataLab, Nuffield Department of Primary Care Health Sciences, University of Oxford,
Oxford, OX2 6GG, UK
Correspondence to: Laurie A Tomlinson; Email: laurie.tomlinson@lshtm.ac.uk
1
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2023.01.20.23284849; this version posted January 22, 2023. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY 4.0 International license .
Abstract
Objective: To compare the effectiveness of Paxlovid vs. sotrovimab and molnupiravir in
preventing severe COVID-19 outcomes in non-hospitalised high-risk COVID-19 adult patients.
Design: With the approval of NHS England, we conducted a real-world cohort study using the
OpenSAFELY-TPP platform.
Setting: Patient-level electronic health record data were obtained from 24 million people
registered with a general practice in England that uses TPP software. The primary care data
were securely linked with data on COVID-19 infection and therapeutics, hospital admission, and
death within the OpenSAFELY-TPP platform, covering a period where both Paxlovid and
sotrovimab were first-line treatment options in community settings.
Participants: Non-hospitalised adult COVID-19 patients at high risk of severe outcomes treated
with Paxlovid, sotrovimab or molnupiravir between February 11, 2022 and October 1, 2022.
Interventions: Paxlovid, sotrovimab or molnupiravir administered in the community by COVID19 Medicine Delivery Units.
Main outcome measure: COVID-19 related hospitalisation or COVID-19 related death within
28 days after treatment initiation.
Results: A total of 7683 eligible patients treated with Paxlovid (n=4836) and sotrovimab
(n=2847) were included in the main analysis. The mean age was 54.3 (SD=14.9) years; 64%
were female, 93% White and 93% had three or more COVID-19 vaccinations. Within 28 days
after treatment initiation, 52 (0.68%) COVID-19 related hospitalisations/deaths were observed
(33 (0.68%) treated with Paxlovid and 19 (0.67%) with sotrovimab). Cox proportional hazards
model stratified by region showed that after adjusting for demographics, high-risk cohort
categories, vaccination status, calendar time, body mass index and other comorbidities,
treatment with Paxlovid was associated with a similar risk of outcome event as treatment with
sotrovimab (HR=1.14, 95% CI: 0.62 to 2.08; P=0.673). Results from propensity score weighted
Cox model also showed comparable risks in these two..
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