Viral load decrease in SARS‐CoV‐2 BA.1 and BA.2 Omicron sublineages infection after treatment with monoclonal antibodies and direct antiviral agents

DOI record: { "DOI": "10.1002/jmv.28186", "ISSN": [ "0146-6615", "1096-9071" ], "URL": "http://dx.doi.org/10.1002/jmv.28186", "abstract": "<jats:title>Abstract</jats:title><jats:sec><jats:label/><jats:p>The efficacy on the Omicron variant of the approved early coronavirus disease‐2019 (COVID‐19) therapies, especially monoclonal antibodies, has been challenged by in vitro neutralization data, while data on in vivo antiviral activity are lacking. We assessed potential decrease from Day 1 to Day 7 viral load (VL) in nasopharyngeal swabs of outpatients receiving Sotrovimab, Molnupiravir, Remdesivir, or Nirmatrelvir/ritonavir for mild‐to‐moderate COVID‐19 due to sublineages BA.1 or BA.2, and average treatment effect by weighted marginal linear regression models. A total of 521 patients (378 BA.1 [73%], 143 [27%] BA.2) received treatments (Sotrovimab 202, Molnupiravir 117, Nirmatrelvir/ritonavir 84, and Remdesivir 118): median age 66 years, 90% vaccinated, median time from symptoms onset 3 days. Day 1 mean VL was 4.12 log2 (4.16 for BA.1 and 4.01 for BA.2). The adjusted analysis showed that Nirmatrelvir/ritonavir significantly reduced VL compared to all the other drugs, except versus Molnupiravir in BA.2. Molnupiravir was superior to Remdesivir in both BA.1 and BA.2, and to Sotrovimab in BA.2. Sotrovimab had better activity than Remdesivir only against BA.1. Nirmatrelvir/ritonavir showed the greatest antiviral activity against Omicron variant, comparable to Molnupiravir only in the BA.2 subgroup. VL decrease could be a valuable surrogate of drug activity in the context of the high prevalence of vaccinated people and low probability of hospital admission.</jats:p></jats:sec>", "alternative-id": [ "10.1002/jmv.28186" ], "assertion": [ { "group": { "label": "Publication History", "name": "publication_history" }, "label": "Received", "name": "received", "order": 0, "value": "2022-07-16" }, { "group": { "label": "Publication History", "name": "publication_history" }, "label": "Accepted", "name": "accepted", "order": 1, "value": "2022-09-26" }, { "group": { "label": "Publication History", "name": "publication_history" }, "label": "Published", "name": "published", "order": 2, "value": "2022-10-07" } ], "author": [ { "ORCID": "https://orcid.org/0000-0002-0240-7504", "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" }, { "name": "PhD course in Microbiology, Immunology, Infectious Diseases, and Transplants (MIMIT) University of Rome Tor Vergata Rome Italy" } ], "authenticated-orcid": false, "family": "Mazzotta", "given": "Valentina", "sequence": "first" }, { "affiliation": [ { "name": "Centre for Clinical Research, Epidemiology, Modelling and Evaluation (CREME), UCL London UK" } ], "family": "Cozzi Lepri", "given": "Alessandro", "sequence": "additional" }, { "affiliation": [ { "name": "Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Colavita", "given": "Francesca", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Rosati", "given": "Silvia", "sequence": "additional" }, { "affiliation": [ { "name": "Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Lalle", "given": "Eleonora", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical Epidemiology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Cimaglia", "given": "Claudia", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Paulicelli", "given": "Jessica", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Mastrorosa", "given": "Ilaria", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Vita", "given": "Serena", "sequence": "additional" }, { "affiliation": [ { "name": "Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Fabeni", "given": "Lavinia", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0001-6944-0686", "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "authenticated-orcid": false, "family": "Vergori", "given": "Alessandra", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Maffongelli", "given": "Gaetano", "sequence": "additional" }, { "affiliation": [ { "name": "Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Carletti", "given": "Fabrizio", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Lanini", "given": "Simone", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Caraffa", "given": "Emanuela", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Milozzi", "given": "Eugenia", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Libertone", "given": "Raffaella", "sequence": "additional" }, { "ORCID": "https://orcid.org/0000-0002-7342-0263", "affiliation": [ { "name": "Clinical Epidemiology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "authenticated-orcid": false, "family": "Piselli", "given": "Pierluca", "sequence": "additional" }, { "affiliation": [ { "name": "Scientific Direction, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Girardi", "given": "Enrico", "sequence": "additional" }, { "affiliation": [ { "name": "Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Garbuglia", "given": "AnnaRosa", "sequence": "additional" }, { "affiliation": [ { "name": "General Direction, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Vaia", "given": "Francesco", "sequence": "additional" }, { "affiliation": [ { "name": "Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Maggi", "given": "Fabrizio", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Nicastri", "given": "Emanuele", "sequence": "additional" }, { "affiliation": [ { "name": "Clinical and Research Infectious Diseases Department National Institute for Infectious Diseases Lazzaro Spallanzani IRCCS Rome Italy" } ], "family": "Antinori", "given": "Andrea", "sequence": "additional" }, { "affiliation": [], "name": "INMI COVID‐19 Outpatient Treatment Study Group", "sequence": "additional" } ], "container-title": "Journal of Medical Virology", "container-title-short": "Journal of Medical Virology", "content-domain": { "crossmark-restriction": true, "domain": [ "onlinelibrary.wiley.com" ] }, "created": { "date-parts": [ [ 2022, 10, 3 ] ], "date-time": "2022-10-03T06:53:05Z", "timestamp": 1664779985000 }, "deposited": { "date-parts": [ [ 2024, 7, 2 ] ], "date-time": "2024-07-02T13:12:59Z", "timestamp": 1719925979000 }, "funder": [ { "DOI": "10.13039/501100000780", "doi-asserted-by": "publisher", "id": [ { "asserted-by": "publisher", "id": "10.13039/501100000780", "id-type": "DOI" } ], "name": "European Commission" }, { "DOI": "10.13039/501100003196", "doi-asserted-by": "publisher", "id": [ { "asserted-by": "publisher", "id": "10.13039/501100003196", "id-type": "DOI" } ], "name": "Ministero della Salute" } ], "indexed": { "date-parts": [ [ 2025, 2, 21 ] ], "date-time": "2025-02-21T02:15:41Z", "timestamp": 1740104141007, "version": "3.37.3" }, "is-referenced-by-count": 18, "issue": "1", "issued": { "date-parts": [ [ 2022, 10, 7 ] ] }, "journal-issue": { "issue": "1", "published-print": { "date-parts": [ [ 2023, 1 ] ] } }, "language": "en", "license": [ { "URL": "http://creativecommons.org/licenses/by-nc-nd/4.0/", "content-version": "vor", "delay-in-days": 0, "start": { "date-parts": [ [ 2022, 10, 7 ] ], "date-time": "2022-10-07T00:00:00Z", "timestamp": 1665100800000 } } ], "link": [ { "URL": "https://onlinelibrary.wiley.com/doi/pdf/10.1002/jmv.28186", "content-type": "application/pdf", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://onlinelibrary.wiley.com/doi/full-xml/10.1002/jmv.28186", "content-type": "application/xml", "content-version": "vor", "intended-application": "text-mining" }, { "URL": "https://onlinelibrary.wiley.com/doi/pdf/10.1002/jmv.28186", "content-type": "unspecified", "content-version": "vor", "intended-application": "similarity-checking" } ], "member": "311", "original-title": [], "prefix": "10.1002", "published": { "date-parts": [ [ 2022, 10, 7 ] ] }, "published-online": { "date-parts": [ [ 2022, 10, 7 ] ] }, "published-print": { "date-parts": [ [ 2023, 1 ] ] }, "publisher": "Wiley", "reference": [ { "key": "e_1_2_10_2_1", "unstructured": "CoVariants. Overview of variants/mutations. April 4 2022.https://covariants.org/per-variant" }, { "DOI": "10.1038/s41586-022-04594-4", "doi-asserted-by": "publisher", "key": "e_1_2_10_3_1" }, { "DOI": "10.1016/j.cell.2021.12.046", "doi-asserted-by": "publisher", "key": "e_1_2_10_4_1" }, { "DOI": "10.1038/s41586-021-04385-3", "doi-asserted-by": "publisher", "key": "e_1_2_10_5_1" }, { "DOI": "10.1038/s41586-021-04389-z", "doi-asserted-by": "publisher", "key": "e_1_2_10_6_1" }, { "DOI": "10.1038/s41586-021-04386-2", "doi-asserted-by": "publisher", "key": "e_1_2_10_7_1" }, { "DOI": "10.1038/s41586-022-04594-4", "doi-asserted-by": "publisher", "key": "e_1_2_10_8_1" }, { "DOI": "10.1038/s41591-022-01792-5", "doi-asserted-by": "publisher", "key": "e_1_2_10_9_1" }, { "DOI": "10.1016/j.antiviral.2022.105252", "doi-asserted-by": "publisher", "key": "e_1_2_10_10_1" }, { "DOI": "10.1056/NEJMc2119407", "doi-asserted-by": "publisher", "key": "e_1_2_10_11_1" }, { "DOI": "10.1056/NEJMc2201933", "doi-asserted-by": "publisher", "key": "e_1_2_10_12_1" }, { "DOI": "10.1056/NEJMoa2102685", "doi-asserted-by": "publisher", "key": "e_1_2_10_13_1" }, { "DOI": "10.1056/NEJMoa2108163", "doi-asserted-by": "publisher", "key": "e_1_2_10_14_1" }, { "DOI": "10.1056/NEJMoa2107934", "doi-asserted-by": "publisher", "key": "e_1_2_10_15_1" }, { "DOI": "10.1056/NEJMoa2116044", "doi-asserted-by": "publisher", "key": "e_1_2_10_16_1" }, { "DOI": "10.1056/NEJMoa2118542", "doi-asserted-by": "publisher", "key": "e_1_2_10_17_1" }, { "DOI": "10.1056/NEJMoa2116846", "doi-asserted-by": "publisher", "key": "e_1_2_10_18_1" }, { "DOI": "10.1016/S0140-6736(22)00462-7", "doi-asserted-by": "publisher", "key": "e_1_2_10_19_1" }, { "article-title": "Comparative evaluation of authorized drugs for treating Covid‐19 patients. health", "author": "Islam T", "journal-title": "Sci Rep", "key": "e_1_2_10_20_1", "volume": "5", "year": "2022" }, { "DOI": "10.1002/jmv.27633", "doi-asserted-by": "publisher", "key": "e_1_2_10_21_1" }, { "DOI": "10.1001/jama.2021.0202", "doi-asserted-by": "publisher", "key": "e_1_2_10_22_1" }, { "DOI": "10.1056/NEJMoa2035002", "doi-asserted-by": "publisher", "key": "e_1_2_10_23_1" }, { "DOI": "10.1016/j.jcv.2021.104869", "doi-asserted-by": "publisher", "key": "e_1_2_10_24_1" }, { "DOI": "10.1016/j.ijid.2022.06.032", "doi-asserted-by": "publisher", "key": "e_1_2_10_25_1" }, { "DOI": "10.1016/j.jcv.2020.104539", "doi-asserted-by": "publisher", "key": "e_1_2_10_26_1" }, { "DOI": "10.1515/cclm-2021-0700", "doi-asserted-by": "publisher", "key": "e_1_2_10_27_1" }, { "DOI": "10.1111/biom.12071", "doi-asserted-by": "publisher", "key": "e_1_2_10_28_1" }, { "DOI": "10.1002/sim.4273", "doi-asserted-by": "publisher", "key": "e_1_2_10_29_1" }, { "DOI": "10.21203/rs.3.rs-1705061/v1", "doi-asserted-by": "crossref", "key": "e_1_2_10_30_1", "unstructured": "ArbelR SagyYW HoshenM et al. Oral Nirmatrelvir and Severe Covid‐19 Outcomes During the Omicron Surge. Research Square. [Preprint posted June 1 2022]. doi:10.21203/rs.3.rs-1705061/v1" }, { "DOI": "10.1101/2022.07.18.500332", "doi-asserted-by": "crossref", "key": "e_1_2_10_31_1", "unstructured": "CaoY SongW WangL et al. Characterizations of enhanced infectivity and antibody evasion of Omicron BA.2.75. 2022. bioRxiv. doi:10.1101/2022.07.18.500332" } ], "reference-count": 30, "references-count": 30, "relation": { "has-preprint": [ { "asserted-by": "object", "id": "10.1101/2022.06.23.22276509", "id-type": "doi" } ] }, "resource": { "primary": { "URL": "https://onlinelibrary.wiley.com/doi/10.1002/jmv.28186" } }, "score": 1, "short-title": [], "source": "Crossref", "subject": [], "subtitle": [], "title": "Viral load decrease in SARS‐CoV‐2 BA.1 and BA.2 Omicron sublineages infection after treatment with monoclonal antibodies and direct antiviral agents", "type": "journal-article", "update-policy": "https://doi.org/10.1002/crossmark_policy", "volume": "95" }