Evidence map›Paper›PMID 37148526›Full record

ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2023

Exploring the Use of Monoclonal Antibodies and Antiviral Therapies for Early Treatment of COVID-19 Outpatients in a Real-World Setting: A Nationwide Study from England and Italy.

Francesco Ciccimarra, Nicoletta Luxi, Chiara Bellitto, Luca L' Abbate, Pasquale De Nardo, Alessia Savoldi, Alison Yeomans, Mariam Molokhia, Evelina Tacconelli, Gianluca Trifirò

Open access · hybridAbstract read
In one paragraph

Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.2field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 6 citations in OpenAlex.

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  6. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 2 countries.

Francesco Ciccimarra *Department of Diagnostics and Public Health, Section of Pharmacology, University of Verona, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Nicoletta Luxi *Department of Medicine, University of Verona, Verona, Italy.
Chiara BellittoDepartment of Diagnostics and Public Health, Section of Pharmacology, University of Verona, Piazzale L.A. Scuro 10, 37134, Verona, Italy.
Luca L' AbbateDepartment of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy.
Pasquale De NardoInfectious Diseases Division, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
Alessia SavoldiInfectious Diseases Division, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
Alison YeomansDrug Safety Research Unit, Southampton, UK.
Mariam MolokhiaDepartment of Life Sciences and Medicine, King's College London, London, UK.
Evelina TacconelliInfectious Diseases Division, Department of Diagnostics and Public Health, University of Verona, Verona, Italy.
Gianluca TrifiròDepartment of Diagnostics and Public Health, Section of Pharmacology, University of Verona, Piazzale L.A. Scuro 10, 37134, Verona, Italy. gianluca.trifiro@univr.it.ORCID http://orcid.org/0000-0003-1147-7296
University of Verona · ITDrug Safety Research Unit · GBKing's College London · GBUniversity of Messina · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundReal-world data on early treatment of coronavirus disease 2019 (COVID-19) outpatients with newly approved therapies are sparse.

aimTo explore the pattern of use of monoclonal antibodies (mAbs)/antiviral therapies approved for early COVID-19 treatment in non-hospitalized patients from England and Italy from December 2021 to October 2022.

methodsPublic national dashboards on weekly mAb/antiviral use and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection diagnoses from the Italian Medicines Agency, the Italian National Institute of Health, National Health Service in England and the UK Government were explored. Prevalence of antiviral use in outpatients during the entire study period and every two weeks was calculated, as a whole and by class and compounds. An interrupted time-series (ITS) analysis was carried out to assess the impact of predominant SARS-CoV-2 variants over time on the prevalence of use of mAbs/antivirals in England and Italy.

resultsOverall, 77,469 and 195,604 doses of mAbs/antivirals were respectively administered to a total of 10,630,903 (7.3 per 1000) and 18,168,365 (10.8 per 1000) patients diagnosed with SARS-CoV-2 infection in England and Italy. Prevalence of use every two weeks increased from 0.07% to 3.1% in England and 0.9% to 2.3% in Italy during the study period. Regarding individual compounds, sotrovimab (prevalence of use, 1.6%) and nirmatrelvir/ritonavir (1.6%) in England, and nirmatrelvir/ritonavir (1.7%) and molnupiravir (0.5%) in Italy, reported the highest prevalence during a 2-week period. In the ITS analysis, the transition from Delta to Omicron variant predominance was associated with a significant increase in the use of sotrovimab, molnupiravir, remdesivir and nirmatrelvir/ritonavir in both England and Italy, with a reduction of other marketed mAbs. The extent of the increase was higher in England than in Italy for all these drugs except for nirmatrelvir/ritonavir.

conclusionsIn this dual nationwide study, the prevalence of use of mAbs/antivirals against SARS-CoV-2 for early outpatients' treatment increased slowly up to 2.0-3.0% of all patients diagnosed with SARS-CoV-2 infection in both England and Italy from December 2021 to October 2022. The trend of individual drug use varied in relation to predominant SARS-CoV-2 variants with some differences across countries. In line with scientific societies' guidelines, nirmatrelvir/ritonavir was the most frequently prescribed antiviral in both countries in the most recent period.

Indexed as

COVID-19SARS-CoV-2Antibodies, MonoclonalAntiviral AgentsCOVID-19 Drug TreatmentCytidineHumansHydroxylaminesLactamsLeucineNitrilesOutpatientsProlineRitonavirState MedicineAntibodies, MonoclonalAntiviral AgentsCytidineHydroxylaminesLactamsLeucinemolnupiravirnirmatrelvirNitrilesProlineRitonavir

Identifiers

PMID37148526
PMCPMC10163563
OpenAlexW4372354727

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.