Real-World Effectiveness of Bebtelovimab Versus Nirmatrelvir/Ritonavir in Outpatients with COVID-19

DOI record: { "DOI": "10.1007/s41030-024-00284-w", "ISSN": [ "2364-1754", "2364-1746" ], "URL": "http://dx.doi.org/10.1007/s41030-024-00284-w", "alternative-id": [ "284" ], "assertion": [ { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Received", "name": "received", "order": 1, "value": "17 October 2024" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "Accepted", "name": "accepted", "order": 2, "value": "6 December 2024" }, { "group": { "label": "Article History", "name": "ArticleHistory" }, "label": "First Online", "name": "first_online", "order": 3, "value": "25 December 2024" }, { "group": { "label": "Declarations", "name": "EthicsHeading" }, "name": "Ethics", "order": 1 }, { "group": { "label": "Conflict of Interest", "name": "EthicsHeading" }, "name": "Ethics", "order": 2, "value": "Russell M. Nichols, Jennifer M. Alyea, Baojin Zhu, and Elsie L. Grace are employees and stockholders of Eli Lilly and Company. Neil Dhopeshwarkar and Kinwei Arnold Chan are employees and stockholders of TriNetX, LLC, Cambridge, MA, USA. Christopher G. Rowan served as a consultant for TriNetX, LLC. Sengwee Toh serves as a methods consultant for TriNetX, LLC for this work and unrelated work for Pfizer, Inc, manufacturer of NR." }, { "group": { "label": "Ethical Approval", "name": "EthicsHeading" }, "name": "Ethics", "order": 3, "value": "No ethics committee was consulted for this study, as it is not considered human subjects research. Exemption from an ethics committee is not required by law or TriNetX policies because the data are fully de-identified per the de-identification standard defined in Sect. 164.514(a) of the HIPAA Privacy Rule and as assessed through formal determination by a qualified expert as defined in Sect. 164.514(b)(1) of the HIPAA Privacy Rule. Additionally, this retrospective study is exempt from informed consent." } ], "author": [ { "affiliation": [], "family": "Rowan", "given": "Christopher G.", "sequence": "first" }, { "ORCID": "https://orcid.org/0000-0001-7771-7366", "affiliation": [], "authenticated-orcid": false, "family": "Nichols", "given": "Russell M.", "sequence": "additional" }, { "affiliation": [], "family": "Dhopeshwarkar", "given": "Neil", "sequence": "additional" }, { "affiliation": [], "family": "Alyea", "given": "Jennifer M.", "sequence": "additional" }, { "affiliation": [], "family": "Zhu", "given": "Baojin", "sequence": "additional" }, { "affiliation": [], "family": "Toh", "given": "Sengwee", "sequence": "additional" }, { "affiliation": [], "family": "Chan", "given": "K. Arnold", "sequence": "additional" }, { "affiliation": [], "family": "Grace", "given": "Elsie L.", "sequence": "additional" } ], "container-title": "Pulmonary Therapy", "container-title-short": "Pulm Ther", "content-domain": { "crossmark-restriction": false, "domain": [ "link.springer.com" ] }, "created": { "date-parts": [ [ 2024, 12, 25 ] ], "date-time": "2024-12-25T16:03:38Z", "timestamp": 1735142618000 }, "deposited": { "date-parts": [ [ 2024, 12, 25 ] ], "date-time": "2024-12-25T17:03:57Z", "timestamp": 1735146237000 }, "funder": [ { "DOI": "10.13039/100004312", "doi-asserted-by": "publisher", "id": [ { "asserted-by": "publisher", "id": "10.13039/100004312", "id-type": "DOI" } ], "name": "Eli Lilly and Company" } ], "indexed": { "date-parts": [ [ 2024, 12, 25 ] ], "date-time": "2024-12-25T17:40:17Z", "timestamp": 1735148417332, "version": "3.32.0" }, "is-referenced-by-count": 0, "issued": { "date-parts": [ [ 2024, 12, 25 ] ] }, "language": "en", "license": [ { "URL": "https://creativecommons.org/licenses/by-nc/4.0", "content-version": "tdm", "delay-in-days": 0, "start": { "date-parts": [ [ 2024, 12, 25 ] ], "date-time": "2024-12-25T00:00:00Z", "timestamp": 1735084800000 } }, { "URL": "https://creativecommons.org/licenses/by-nc/4.0", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2024, 12, 25 ] ], "date-time": "2024-12-25T00:00:00Z", "timestamp": 1735084800000 } } ], "link": [ { "URL": "https://link.springer.com/content/pdf/10.1007/s41030-024-00284-w.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/article/10.1007/s41030-024-00284-w/fulltext.html", "content-type": "text/html", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://link.springer.com/content/pdf/10.1007/s41030-024-00284-w.pdf", "content-type": "application/pdf", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "297", "original-title": [], "prefix": "10.1007", "published": { "date-parts": [ [ 2024, 12, 25 ] ] }, "published-online": { "date-parts": [ [ 2024, 12, 25 ] ] }, "publisher": "Springer Science and Business Media LLC", "reference": [ { "key": "284_CR1", "unstructured": "World Health Organization. COVID-19 Public Health Emergency of International Concern (PHEIC) Global research and innovation forum. 2020. https://www.who.int/publications/m/item/covid-19-public-health-emergency-of-international-concern-(pheic)-global-research-and-innovation-forum#:~:text=On%2030%20January%202020%20following,of%20International%20Concern%20(PHEIC). Accessed 13 Dec 2023." }, { "key": "284_CR2", "unstructured": "Food and Drug Administration (FDA). Coronavirus Treatment Acceleration Program (CTAP). 2023. https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap. Accessed 12 Feb 2024." }, { "key": "284_CR3", "unstructured": "Food and Drug Administration (FDA). Emergency Use Authorization 090. 2021. https://www.fda.gov/media/143602/download. Accessed 15 Jan 2023." }, { "key": "284_CR4", "unstructured": "Food and Drug Administration (FDA). Emergency Use Authorization 094. 2022. https://www.fda.gov/media/145801/download. Accessed 16 Jan 2024." }, { "key": "284_CR5", "unstructured": "Food and Drug Administration (FDA). Emergency Use Authorization 091. 2022. https://www.fda.gov/media/145610/download. Accessed 12 Jan 2024." }, { "key": "284_CR6", "unstructured": "Food and Drug Administration (FDA). Emergency Use Authorization 100. 2022. https://www.fda.gov/media/149532/download. Accessed 15 Jan 2024." }, { "key": "284_CR7", "unstructured": "Food and Drug Administration (FDA). FDA revises letter of authorization for the emergency use authorization for Paxlovid. 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-revises-letter-authorization-emergency-use-authorization-paxlovid. Accessed 12 Jun 2024." }, { "key": "284_CR8", "unstructured": "Food and Drug Administration (FDA). Emergency Use Authorization (EUA) for Bebtelovimab (LY-CoV1404). 2022. https://www.fda.gov/media/156396/download. Accessed 16 Jan 2024." }, { "key": "284_CR9", "unstructured": "Food and Drug Administration (FDA). Emergency Use Authorization 090. 2021. https://www.fda.gov/media/147629/download. Accessed 15 Jan 2024." }, { "key": "284_CR10", "unstructured": "Food and Drug administration (FDA). Frequently Asked Questions on the Emergency Use Authorization for Bamlanivimab and Etesevimab. 2022. https://www.fda.gov/media/145808/download. Accessed 12 Feb 2024." }, { "key": "284_CR11", "unstructured": "Food and Drug administration (FDA). Frequently Asked Questions on the Emergency Use Authorization of REGEN-COV (Casirivimab and Imdevimab). 2022. Available https://www.fda.gov/media/143894/download. Accessed 12 Feb 2024." }, { "key": "284_CR12", "unstructured": "Food and Drug Administration (FDA). FDA updates Sotrovimab emergency use authorization. 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization#:~:text=%5B2%2F25%2F2022%5D,not%20susceptible%20to%20this%20treatment. Accessed 15 Jan 2024." }, { "DOI": "10.1093/ofid/ofac517", "author": "EK McCreary", "doi-asserted-by": "publisher", "first-page": "ofac517", "issue": "10", "journal-title": "Open Forum Infect Dis", "key": "284_CR13", "unstructured": "McCreary EK, Kip KE, Collins K, et al. Evaluation of bebtelovimab for treatment of COVID-19 during the SARS-CoV-2 omicron variant era. Open Forum Infect Dis. 2022;9(10):ofac517.", "volume": "9", "year": "2022" }, { "DOI": "10.1093/infdis/jiac346", "author": "RR Razonable", "doi-asserted-by": "publisher", "first-page": "1683", "issue": "10", "journal-title": "J Infect Dis", "key": "284_CR14", "unstructured": "Razonable RR, O’Horo JC, Hanson SN, et al. Comparable outcomes for bebtelovimab and ritonavir-boosted nirmatrelvir treatment in high-risk patients with coronavirus disease-2019 during severe acute respiratory syndrome coronavirus 2 BA.2 omicron epoch. J Infect Dis. 2022;226(10):1683–7.", "volume": "226", "year": "2022" }, { "key": "284_CR15", "unstructured": "Food and Drug Administration (FDA). FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-bebtelovimab-not-currently-authorized-any-us-region. Accessed 6 Jun 2024." }, { "DOI": "10.1097/EDE.0b013e3181a663cc", "author": "S Schneeweiss", "doi-asserted-by": "publisher", "first-page": "512", "issue": "4", "journal-title": "Epidemiology", "key": "284_CR16", "unstructured": "Schneeweiss S, Rassen JA, Glynn RJ, et al. High-dimensional propensity score adjustment in studies of treatment effects using health care claims data. Epidemiology. 2009;20(4):512–22.", "volume": "20", "year": "2009" }, { "key": "284_CR17", "unstructured": "Food and Drug Administration (FDA). Non-Inferiority Clinical Trials to Establish Effectiveness. Guidance for Industry. 2016. https://www.fda.gov/media/78504/download. Accessed 16 Jan 2024." }, { "DOI": "10.1056/NEJMoa2118542", "author": "J Hammond", "doi-asserted-by": "publisher", "first-page": "1397", "issue": "15", "journal-title": "N Engl J Med", "key": "284_CR18", "unstructured": "Hammond J, Leister-Tebbe H, Gardner A, et al. Oral nirmatrelvir for high-risk, nonhospitalized adults with Covid-19. N Engl J Med. 2022;386(15):1397–408.", "volume": "386", "year": "2022" }, { "DOI": "10.1002/jmv.28801", "author": "TH Liu", "doi-asserted-by": "publisher", "issue": "5", "journal-title": "J Med Virol", "key": "284_CR19", "unstructured": "Liu TH, Huang PY, Wu JY, et al. Clinical effectiveness of nirmatrelvir plus ritonavir in patients with COVID-19 and substance use disorders based on real-world data. J Med Virol. 2023;95(5):e28801.", "volume": "95", "year": "2023" } ], "reference-count": 19, "references-count": 19, "relation": {}, "resource": { "primary": { "URL": "https://link.springer.com/10.1007/s41030-024-00284-w" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [], "subtitle": [], "title": "Real-World Effectiveness of Bebtelovimab Versus Nirmatrelvir/Ritonavir in Outpatients with COVID-19", "type": "journal-article", "update-policy": "https://doi.org/10.1007/springer_crossmark_policy" }