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All Studies   Meta Analysis    Recent:   

Treatment with sotrovimab for SARS-CoV-2 infection in a cohort of high-risk kidney transplant recipients

Villanego et al., Clinical Kidney Journal, doi:10.1093/ckj/sfac177
Jul 2022  
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Sotrovimab for COVID-19
40th treatment shown to reduce risk in May 2023
 
*, now with p = 0.0052 from 23 studies, recognized in 38 countries. Efficacy is variant dependent.
Lower risk for hospitalization.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,300+ studies for 77 treatments. c19early.org
Retrospective 82 kidney transplant recipients treated with sotrovimab, showing lower risk of serious COVID-19 outcomes with early treatment.
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 US EUA has been revoked.
Villanego et al., 28 Jul 2022, retrospective, Spain, peer-reviewed, median age 63.0, 25 authors, study period 1 December, 2021 - 28 February, 2022. Contact: mauxiliadora.mazuecos.sspa@juntadeandalucia.es.
This PaperSotrovimabAll
Treatment with sotrovimab for SARS-CoV-2 infection in a cohort of high-risk kidney transplant recipients
Florentino Villanego, Auxiliadora Mazuecos, Beatriz Cubillo, M José Merino, Inmaculada Poveda, Isabel M Saura, Óscar Segurado, Leónidas Cruzado, Myriam Eady, Sofía Zárraga, M José Aladrén, Sheila Cabello, Verónica López, Esther González, Inmaculada Lorenzo, Jordi Espí-Reig, Constantino Fernández, July Osma, M Carmen Ruiz-Fuentes, Néstor Toapanta, Antonio Franco, Carla C Burballa, Miguel A Muñoz, Marta Crespo, Julio Pascual
Clinical Kidney Journal, doi:10.1093/ckj/sfac177
Background. Sotrovimab is a neutralizing monoclonal antibody (mAb) that seems to remain active against recent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants. The evidence on its use in kidney transplant (KT) recipients, however, is limited. Methods. We performed a multicenter, retrospective cohort study of 82 KT patients with SARS-CoV-2 infection {coronavirus disease 2019 [COVID-19]} treated with sotrovimab. Results. Median age was 63 years. Diabetes was present in 43.9% of patients, and obesity in 32.9% of patients; 48.8% of patients had an estimated glomerular filtration rate under 30 mL/minute/1.73 m 2 . Additional anti-COVID-19 therapies were administered to 56 patients, especially intravenous steroids (65.9%). Sotrovimab was administered early (<5 days from the onset of the symptoms) in 46 patients (56%). Early-treated patients showed less likely progression to severe COVID-19 than those treated later, represented as a lower need for ventilator support (2.2% vs 36.1%; P < .001) or intensive care admission (2.2% vs 25%; P = .002) and COVID-19-related mortality (2.2% vs 16.7%; P = .020). In the multivariable analysis, controlling for baseline risk factors to severe COVID-19 in KT recipients, early use of sotrovimab remained as a protective factor for a composite outcome, including need for ventilator support, intensive care, and COVID-19-related mortality. No anaphylactic reactions, acute rejection episodes, impaired kidney function events, or non-kidney side effects related to sotrovimab were observed. Conclusions. Sotrovimab had an excellent safety profile, even in high-comorbidity patients and advanced chronic kidney disease stages. Earlier administration could prevent progression to severe disease, while clinical outcomes were poor in patients treated later. Larger controlled studies enrolling KT recipients are warranted to elucidate the true efficacy of monoclonal antibody therapies.
SUPPLEMENTARY DATA Supplementary data are available at ckj online. AUTHORS' CONTRIBUTIONS F.V., A.M., M.C., and J.P. designed the study, analyzed the data, and drafted the article. All authors revised the article, made substantial contributions, and approved the final version of the article. F.V. and A.M. have contributed equally to this work. M.C. and J.P. share senior authorship to this work. CONFLICT OF INTEREST STATEMENT None declared.
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The evidence on its use in kidney transplant (KT) recipients, however, is ' 'limited.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>We performed a multicenter, retrospective cohort study of 82 KT ' 'patients with SARS-CoV-2 infection {coronavirus disease 2019 [COVID-19]} treated with ' 'sotrovimab.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>Median age was 63 years. Diabetes was present in 43.9% of patients, ' 'and obesity in 32.9% of patients; 48.8% of patients had an estimated glomerular filtration ' 'rate under 30\xa0mL/minute/1.73\xa0m2. Additional anti–COVID-19 therapies were administered ' 'to 56 patients, especially intravenous steroids (65.9%). Sotrovimab was administered early ' '(&amp;lt;5 days from the onset of the symptoms) in 46 patients (56%). 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Meeting of the Committee for ' 'Medicinal Products for Human Use in December 2021 [in Spanish]. January 4, ' '2022.'}, { 'key': '2022092209482088600_bib23', 'author': 'Spanish Agency of Medicines and Medical Devices'}, {'key': '2022092209482088600_bib24', 'author': 'European Medicines Agency'}, {'key': '2022092209482088600_bib25', 'author': 'Government of Spain Ministry of Health'}, { 'key': '2022092209482088600_bib26', 'author': 'The Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC)'}, { 'key': '2022092209482088600_bib27', 'doi-asserted-by': 'crossref', 'first-page': 'c179', 'DOI': '10.1159/000339789', 'article-title': 'KDIGO clinical practice guideline for acute kidney injury', 'volume': '120', 'author': 'Khwaja', 'year': '2012', 'journal-title': 'Nephron Clin Pract'}, { 'key': '2022092209482088600_bib28', 'doi-asserted-by': 'crossref', 'first-page': '265', 'DOI': '10.1016/j.nefroe.2020.03.017', 'article-title': 'Recommendations on management of the SARS-CoV-2 coronavirus pandemic ' '(Covid-19) in kidney transplant patients', 'volume': '40', 'author': 'López', 'year': '2020', 'journal-title': 'Nefrologia (Engl Ed)'}, { 'key': '2022092209482088600_bib29', 'doi-asserted-by': 'crossref', 'first-page': '435', 'DOI': '10.3390/medicina57050435', 'article-title': 'The management of immunosuppression in kidney transplant recipients ' 'with COVID-19 disease: an update and systematic review of the ' 'literature', 'volume': '57', 'author': 'Angelico', 'year': '2021', 'journal-title': 'Medicina (Kaunas)'}, { 'key': '2022092209482088600_bib30', 'doi-asserted-by': 'crossref', 'first-page': '2573', 'DOI': '10.1111/ajt.16579', 'article-title': 'Predictors of severe COVID-19 in kidney transplant recipients in the ' 'different epidemic waves: analysis of the Spanish Registry', 'volume': '21', 'author': 'Villanego', 'year': '2021', 'journal-title': 'Am J Transplant'}, { 'key': '2022092209482088600_bib31', 'first-page': '622', 'article-title': 'Efficacy and safety of two neutralising monoclonal antibody therapies, ' 'sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with ' 'COVID-19 (TICO): a randomised controlled trial', 'volume': '22', 'author': 'ACTIV-3/Therapeutics for Inpatients with COVID-19 (TICO) Study Group', 'year': '2021', 'journal-title': 'Lancet Infect Dis.'}, { 'key': '2022092209482088600_bib32', 'doi-asserted-by': 'crossref', 'first-page': '2305', 'DOI': '10.1016/j.ekir.2021.06.023', 'article-title': 'Use and safety of remdesivir in kidney transplant recipients with ' 'COVID-19', 'volume': '6', 'author': 'Buxeda', 'year': '2021', 'journal-title': 'Kidney Int Rep'}, { 'key': '2022092209482088600_bib33', 'doi-asserted-by': 'crossref', 'first-page': '2083', 'DOI': '10.1111/ajt.17027', 'article-title': 'Early clinical experience with nirmatrelvir/ritonavir for the treatment ' 'of COVID-19 in solid organ transplant recipients', 'volume': '22', 'author': 'Salerno', 'year': '2022', 'journal-title': 'Am J Transplant'}, { 'key': '2022092209482088600_bib34', 'doi-asserted-by': 'crossref', 'article-title': 'Comparative effectiveness of sotrovimab and molnupiravir for prevention ' 'of severe COVID-19 outcomes in non-hospitalised patients: an ' 'observational cohort study using the OpenSAFELY platform', 'author': 'Zheng', 'DOI': '10.1101/2022.05.22.22275417'}, { 'key': '2022092209482088600_bib35', 'doi-asserted-by': 'crossref', 'first-page': '1475', 'DOI': '10.1056/NEJMc2201933', 'article-title': 'Efficacy of antiviral agents against the SARS-CoV-2 omicron subvariant ' 'BA.2', 'volume': '386', 'author': 'Takashita', 'year': '2022', 'journal-title': 'N Eng J Med'}, { 'key': '2022092209482088600_bib36', 'doi-asserted-by': 'crossref', 'first-page': '3824', 'DOI': '10.1038/s41467-022-31615-7', 'article-title': 'Resilience of S309 and AZD7442 monoclonal antibody treatments against ' 'infection by SARS-CoV-2 omicron lineage strains', 'volume': '13', 'author': 'Case', 'year': '2022', 'journal-title': 'Nat Commun'}, { 'key': '2022092209482088600_bib37', 'article-title': 'Characterization and antiviral susceptibility of SARS-CoV-2 ' 'omicron/BA.2', 'author': 'Kawaoka', 'journal-title': 'Res Sq'}, { 'key': '2022092209482088600_bib38', 'article-title': 'Omicron BA.2 (B.1.1.529.2): high potential to becoming the next ' 'dominating variant', 'author': 'Chen', 'journal-title': 'Res Sq'}, {'key': '2022092209482088600_bib39', 'author': 'US Food and Drug Administration'}, { 'key': '2022092209482088600_bib40', 'author': 'National Institutes of Health COVID-19 Treatment Guidelines'}], 'container-title': 'Clinical Kidney Journal', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://academic.oup.com/ckj/advance-article-pdf/doi/10.1093/ckj/sfac177/45505732/sfac177.pdf', 'content-type': 'application/pdf', 'content-version': 'am', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/ckj/article-pdf/15/10/1847/45972170/sfac177.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/ckj/article-pdf/15/10/1847/45972170/sfac177.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 9, 22]], 'date-time': '2022-09-22T09:50:25Z', 'timestamp': 1663840225000}, 'score': 1, 'resource': {'primary': {'URL': 'https://academic.oup.com/ckj/article/15/10/1847/6651282'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 7, 28]]}, 'references-count': 40, 'journal-issue': { 'issue': '10', 'published-online': {'date-parts': [[2022, 7, 28]]}, 'published-print': {'date-parts': [[2022, 9, 22]]}}, 'URL': 'http://dx.doi.org/10.1093/ckj/sfac177', 'relation': {}, 'ISSN': ['2048-8505', '2048-8513'], 'subject': ['Transplantation', 'Nephrology'], 'published-other': {'date-parts': [[2022, 10]]}, 'published': {'date-parts': [[2022, 7, 28]]}}
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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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