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All Studies   Meta Analysis    Recent:   

Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe covid-19 outcomes in patients in the community: observational cohort study with the OpenSAFELY platform

Zheng et al., BMJ, doi:10.1136/bmj-2022-071932
Nov 2022  
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0 0.5 1 1.5 2+ Death/hospitalization, d.. 50% Improvement Relative Risk Death/hospitalizatio.. (b) 46% Sotrovimab for COVID-19  Zheng et al.  EARLY TREATMENT Is early treatment with sotrovimab beneficial for COVID-19? Retrospective 6,020 patients in the United Kingdom (Dec 2021 - Feb 2022) Study compares with molnupiravir, results vs. placebo may differ Lower death/hosp. with sotrovimab (p=0.0047) c19early.org Zheng et al., BMJ, November 2022 Favors sotrovimab Favors molnupiravir
Sotrovimab for COVID-19
40th treatment shown to reduce risk in May 2023
 
*, now known with p = 0.0017 from 22 studies, recognized in 38 countries. Efficacy is variant dependent.
Lower risk for hospitalization.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
Retrospective 3,331 sotrovimab and 2,689 molnupiravir patients in the UK, showing lower risk of combined hospitalization/death with sotrovimab.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.11-3, BA.4, BA.54, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.15, and no efficacy for BA.26, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.15. US EUA has been revoked.
Study covers sotrovimab and molnupiravir.
risk of death/hospitalization, 50.0% lower, HR 0.50, p = 0.005, treatment 34 of 3,331 (1.0%), control 61 of 2,689 (2.3%), NNT 80, adjusted per study, multivariable, Cox proportional hazards, day 60, model 4.
risk of death/hospitalization, 46.0% lower, HR 0.54, p = 0.01, treatment 32 of 3,331 (1.0%), control 55 of 2,689 (2.0%), NNT 92, adjusted per study, multivariable, Cox proportional hazards, day 28, model 4.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Zheng et al., 16 Nov 2022, retrospective, United Kingdom, peer-reviewed, mean age 52.0, 33 authors, study period 16 December, 2021 - 10 February, 2022, this trial compares with another treatment - results may be better when compared to placebo. Contact: laurie.tomlinson@lshtm.ac.uk.
This PaperSotrovimabAll
Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe covid-19 outcomes in patients in the community: observational cohort study with the OpenSAFELY platform
Bang Zheng, Amelia C A Green, John Tazare, Helen J Curtis, Louis Fisher, Linda Nab, Anna Schultze, Viyaasan Mahalingasivam, Edward P K Parker, William J Hulme, Sebastian C J Bacon, Nicholas J Devito, Christopher Bates, David Evans, Peter Inglesby, Henry Drysdale, Simon Davy, Jonathan Cockburn, Caroline E Morton, George Hickman, Tom Ward, Rebecca M Smith, John Parry, Frank Hester, Sam Harper, Amir Mehrkar, Rosalind M Eggo, Alex J Walker, Stephen J W Evans, Ian J Douglas, Brian Mackenna, Ben Goldacre, Laurie A Tomlinson
BMJ, doi:10.1136/bmj-2022-071932
Objective To compare the effectiveness of sotrovimab (a neutralising monoclonal antibody) with molnupiravir (an antiviral) in preventing severe outcomes of covid-19 in adult patients infected with SARS-CoV-2 in the community and at high risk of severe outcomes from covid-19. Design Observational cohort study with the OpenSAFELY platform. setting With the approval of NHS England, a real world cohort study was conducted with the OpenSAFELY-TPP platform (a secure, transparent, open source software platform for analysis of NHS electronic health records), and 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 SARS-CoV-2 infection and treatments, hospital admission, and death, over a period when both drug treatments were frequently prescribed in community settings. ParticiPants Adult patients with covid-19 in the community at high risk of severe outcomes from covid-19, treated with sotrovimab or molnupiravir from 16 December 2021. interventiOns Sotrovimab or molnupiravir given in the community by covid-19 medicine delivery units. Main OutcOMe Measures Admission to hospital with covid-19 (ie, with covid-19 as the primary diagnosis) or death from covid-19 (ie, with covid-19 as the underlying or contributing cause of death) within 28 days of the start of treatment. results Between 16 December 2021 and 10 February 2022, 3331 and 2689 patients were treated with sotrovimab and molnupiravir, respectively, with no substantial differences in baseline characteristics. Mean age of all 6020 patients was 52 (standard deviation 16) years; 59% were women, 89% were white, and 88% had received three or more covid-19 vaccinations. Within 28 days of the start of treatment, 87 (1.4%) patients were admitted to hospital or died of infection from SARS-CoV-2 (32 treated with sotrovimab and 55 with molnupiravir). Cox proportional hazards models stratified by area showed that after adjusting for demographic information, high risk cohort categories, vaccination status, calendar time, body mass index, and other comorbidities, treatment with sotrovimab was associated with a substantially lower risk than treatment with molnupiravir (hazard ratio 0.54, 95% confidence interval 0.33 to 0.88, P=0.01). Consistent results were found from propensity score weighted Cox models (0.50, 0.31 to 0.81, P=0.005) and when restricted to people who were fully vaccinated (0.53, 0.31 to 0.90, P=0.02). No substantial effect modifications by other characteristics were detected (all P values for interaction >0.10). The findings were
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The primary care data were securely linked with data on SARS-CoV-2 infection ' 'and treatments, hospital admission, and death, over a period when both drug treatments were ' 'frequently prescribed in community settings.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Participants</jats:title>\n' ' <jats:p>Adult patients with covid-19 in the community at high risk of severe ' 'outcomes from covid-19, treated with sotrovimab or molnupiravir from 16 December ' '2021.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Interventions</jats:title>\n' ' <jats:p>Sotrovimab or molnupiravir given in the community by covid-19 medicine ' 'delivery units.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Main outcome measures</jats:title>\n' ' <jats:p>Admission to hospital with covid-19 (ie, with covid-19 as the primary ' 'diagnosis) or death from covid-19 (ie, with covid-19 as the underlying or contributing cause ' 'of death) within 28 days of the start of treatment.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>Between 16 December 2021 and 10 February 2022, 3331 and 2689 patients ' 'were treated with sotrovimab and molnupiravir, respectively, with no substantial differences ' 'in baseline characteristics. Mean age of all 6020 patients was 52 (standard deviation 16) ' 'years; 59% were women, 89% were white, and 88% had received three or more covid-19 ' 'vaccinations. Within 28 days of the start of treatment, 87 (1.4%) patients were admitted to ' 'hospital or died of infection from SARS-CoV-2 (32 treated with sotrovimab and 55 with ' 'molnupiravir). Cox proportional hazards models stratified by area showed that after adjusting ' 'for demographic information, high risk cohort categories, vaccination status, calendar time, ' 'body mass index, and other comorbidities, treatment with sotrovimab was associated with a ' 'substantially lower risk than treatment with molnupiravir (hazard ratio 0.54, 95% confidence ' 'interval 0.33 to 0.88, P=0.01). Consistent results were found from propensity score weighted ' 'Cox models (0.50, 0.31 to 0.81, P=0.005) and when restricted to people who were fully ' 'vaccinated (0.53, 0.31 to 0.90, P=0.02). No substantial effect modifications by other ' 'characteristics were detected (all P values for interaction &gt;0.10). The findings were ' 'similar in an exploratory analysis of patients treated between 16 February and 1 May 2022 ' 'when omicron BA.2 was the predominant variant in England.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>In routine care of adult patients in England with covid-19 in the ' 'community, at high risk of severe outcomes from covid-19, those who received sotrovimab were ' 'at lower risk of severe outcomes of covid-19 than those treated with molnupiravir.</jats:p>\n' ' </jats:sec>', 'DOI': '10.1136/bmj-2022-071932', 'type': 'journal-article', 'created': { 'date-parts': [[2022, 11, 17]], 'date-time': '2022-11-17T01:12:28Z', 'timestamp': 1668647548000}, 'page': 'e071932', 'update-policy': 'http://dx.doi.org/10.1136/crossmarkpolicy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Comparative effectiveness of sotrovimab and molnupiravir for prevention of severe covid-19 ' 'outcomes in patients in the community: observational cohort study with the OpenSAFELY platform', 'prefix': '10.1136', 'author': [ {'given': 'Bang', 'family': 'Zheng', 'sequence': 'first', 'affiliation': []}, {'given': 'Amelia C A', 'family': 'Green', 'sequence': 'additional', 'affiliation': []}, {'given': 'John', 'family': 'Tazare', 'sequence': 'additional', 'affiliation': []}, {'given': 'Helen J', 'family': 'Curtis', 'sequence': 'additional', 'affiliation': []}, {'given': 'Louis', 'family': 'Fisher', 'sequence': 'additional', 'affiliation': []}, {'given': 'Linda', 'family': 'Nab', 'sequence': 'additional', 'affiliation': []}, {'given': 'Anna', 'family': 'Schultze', 'sequence': 'additional', 'affiliation': []}, {'given': 'Viyaasan', 'family': 'Mahalingasivam', 'sequence': 'additional', 'affiliation': []}, {'given': 'Edward P K', 'family': 'Parker', 'sequence': 'additional', 'affiliation': []}, {'given': 'William J', 'family': 'Hulme', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sebastian C J', 'family': 'Bacon', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nicholas J', 'family': 'DeVito', 'sequence': 'additional', 'affiliation': []}, {'given': 'Christopher', 'family': 'Bates', 'sequence': 'additional', 'affiliation': []}, {'given': 'David', 'family': 'Evans', 'sequence': 'additional', 'affiliation': []}, {'given': 'Peter', 'family': 'Inglesby', 'sequence': 'additional', 'affiliation': []}, {'given': 'Henry', 'family': 'Drysdale', 'sequence': 'additional', 'affiliation': []}, {'given': 'Simon', 'family': 'Davy', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jonathan', 'family': 'Cockburn', 'sequence': 'additional', 'affiliation': []}, {'given': 'Caroline E', 'family': 'Morton', 'sequence': 'additional', 'affiliation': []}, {'given': 'George', 'family': 'Hickman', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tom', 'family': 'Ward', 'sequence': 'additional', 'affiliation': []}, {'given': 'Rebecca M', 'family': 'Smith', 'sequence': 'additional', 'affiliation': []}, {'given': 'John', 'family': 'Parry', 'sequence': 'additional', 'affiliation': []}, {'given': 'Frank', 'family': 'Hester', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sam', 'family': 'Harper', 'sequence': 'additional', 'affiliation': []}, {'given': 'Amir', 'family': 'Mehrkar', 'sequence': 'additional', 'affiliation': []}, {'given': 'Rosalind M', 'family': 'Eggo', 'sequence': 'additional', 'affiliation': []}, {'given': 'Alex J', 'family': 'Walker', 'sequence': 'additional', 'affiliation': []}, {'given': 'Stephen J W', 'family': 'Evans', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ian J', 'family': 'Douglas', 'sequence': 'additional', 'affiliation': []}, {'given': 'Brian', 'family': 'MacKenna', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ben', 'family': 'Goldacre', 'sequence': 'additional', 'affiliation': []}, { 'ORCID': 'http://orcid.org/0000-0001-8848-9493', 'authenticated-orcid': False, 'given': 'Laurie A', 'family': 'Tomlinson', 'sequence': 'additional', 'affiliation': []}], 'member': '239', 'published-online': {'date-parts': [[2022, 11, 16]]}, 'reference': [ { 'key': '2022111621001198000_379.nov16_9.e071932.1', 'doi-asserted-by': 'publisher', 'DOI': '10.1136/bmj.m3379'}, { 'key': '2022111621001198000_379.nov16_9.e071932.2', 'doi-asserted-by': 'publisher', 'DOI': '10.1101/2022.03.07.22272026'}, { 'key': '2022111621001198000_379.nov16_9.e071932.3', 'unstructured': 'NHS. 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