Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry.
COVID-19
Haematology
Malignancy
Nirmatrelvir
SARS-CoV-2
Journal
EClinicalMedicine
ISSN: 2589-5370
Titre abrégé: EClinicalMedicine
Pays: England
ID NLM: 101733727
Informations de publication
Date de publication:
Apr 2023
Apr 2023
Historique:
received:
29
11
2022
revised:
15
03
2023
accepted:
15
03
2023
medline:
13
4
2023
entrez:
12
4
2023
pubmed:
13
4
2023
Statut:
ppublish
Résumé
Nirmatrelvir/ritonavir treatment decreases the hospitalisation rate in immunocompetent patients with COVID-19, but data on efficacy in patients with haematological malignancy are scarce. Here, we describe the outcome of nirmatrelvir/ritonavir treatment in a large cohort of the latter patients. This is a retrospective cohort study from the multicentre EPICOVIDEHA registry (NCT04733729) on patients with haematological malignancy, who were diagnosed with COVID-19 between January and September 2022. Patients receiving nirmatrelvir/ritonavir were compared to those who did not. A logistic regression was run to determine factors associated with nirmatrelvir/ritonavir administration in our sample. Mortality between treatment groups was assessed with Kaplan-Meier survival plots after matching all the patients with a propensity score. Additionally, a Cox regression was modelled to detect factors associated with mortality in patients receiving nirmatrelvir/ritonavir. A total of 1859 patients were analysed, 117 (6%) were treated with nirmatrelvir/ritonavir, 1742 (94%) were treated otherwise. Of 117 patients receiving nirmatrelvir/ritonavir, 80% had received ≥1 anti-SARS-CoV-2 vaccine dose before COVID-19 onset, 13% of which received a 2nd vaccine booster. 5% were admitted to ICU. Nirmatrelvir/ritonavir treatment was associated with the presence of extrapulmonary symptoms at COVID-19 onset, for example anosmia, fever, rhinitis, or sinusitis (aOR 2.509, 95%CI 1.448-4.347) and 2nd vaccine booster (aOR 3.624, 95%CI 1.619-8.109). Chronic pulmonary disease (aOR 0.261, 95%CI 0.093-0.732) and obesity (aOR 0.105, 95%CI 0.014-0.776) were not associated with nirmatrelvir/ritonavir use. After propensity score matching, day-30 mortality rate in patients treated with nirmatrelvir/ritonavir was 2%, significantly lower than in patients with SARS-CoV-2 directed treatment other than nirmatrelvir/ritonavir (11%, p = 0.036). No factor was observed explaining the mortality difference in patients after nirmatrelvir/ritonavir administration. Haematological malignancy patients were more likely to receive nirmatrelvir/ritonavir when reporting extrapulmonary symptoms or 2nd vaccine booster at COVID-19 onset, as opposed to chronic pulmonary disease and obesity. The mortality rate in patients treated with nirmatrelvir/ritonavir was lower than in patients with targeted drugs other than nirmatrelvir/ritonavir. EPICOVIDEHA has received funds from Optics COMMIT (COVID-19 Unmet Medical Needs and Associated Research Extension) COVID-19 RFP program by GILEAD Science, United States (Project 2020-8223).
Sections du résumé
Background
UNASSIGNED
Nirmatrelvir/ritonavir treatment decreases the hospitalisation rate in immunocompetent patients with COVID-19, but data on efficacy in patients with haematological malignancy are scarce. Here, we describe the outcome of nirmatrelvir/ritonavir treatment in a large cohort of the latter patients.
Methods
UNASSIGNED
This is a retrospective cohort study from the multicentre EPICOVIDEHA registry (NCT04733729) on patients with haematological malignancy, who were diagnosed with COVID-19 between January and September 2022. Patients receiving nirmatrelvir/ritonavir were compared to those who did not. A logistic regression was run to determine factors associated with nirmatrelvir/ritonavir administration in our sample. Mortality between treatment groups was assessed with Kaplan-Meier survival plots after matching all the patients with a propensity score. Additionally, a Cox regression was modelled to detect factors associated with mortality in patients receiving nirmatrelvir/ritonavir.
Findings
UNASSIGNED
A total of 1859 patients were analysed, 117 (6%) were treated with nirmatrelvir/ritonavir, 1742 (94%) were treated otherwise. Of 117 patients receiving nirmatrelvir/ritonavir, 80% had received ≥1 anti-SARS-CoV-2 vaccine dose before COVID-19 onset, 13% of which received a 2nd vaccine booster. 5% were admitted to ICU. Nirmatrelvir/ritonavir treatment was associated with the presence of extrapulmonary symptoms at COVID-19 onset, for example anosmia, fever, rhinitis, or sinusitis (aOR 2.509, 95%CI 1.448-4.347) and 2nd vaccine booster (aOR 3.624, 95%CI 1.619-8.109). Chronic pulmonary disease (aOR 0.261, 95%CI 0.093-0.732) and obesity (aOR 0.105, 95%CI 0.014-0.776) were not associated with nirmatrelvir/ritonavir use. After propensity score matching, day-30 mortality rate in patients treated with nirmatrelvir/ritonavir was 2%, significantly lower than in patients with SARS-CoV-2 directed treatment other than nirmatrelvir/ritonavir (11%, p = 0.036). No factor was observed explaining the mortality difference in patients after nirmatrelvir/ritonavir administration.
Interpretation
UNASSIGNED
Haematological malignancy patients were more likely to receive nirmatrelvir/ritonavir when reporting extrapulmonary symptoms or 2nd vaccine booster at COVID-19 onset, as opposed to chronic pulmonary disease and obesity. The mortality rate in patients treated with nirmatrelvir/ritonavir was lower than in patients with targeted drugs other than nirmatrelvir/ritonavir.
Funding
UNASSIGNED
EPICOVIDEHA has received funds from Optics COMMIT (COVID-19 Unmet Medical Needs and Associated Research Extension) COVID-19 RFP program by GILEAD Science, United States (Project 2020-8223).
Identifiants
pubmed: 37041967
doi: 10.1016/j.eclinm.2023.101939
pii: S2589-5370(23)00116-5
pmc: PMC10078172
doi:
Types de publication
Journal Article
Langues
eng
Pagination
101939Investigateurs
Klára Piukovics
(K)
Cristina De Ramón
(C)
François Danion
(F)
Ayel Yahya
(A)
Anna Guidetti
(A)
Carolina Garcia-Vidal
(C)
Uluhan Sili
(U)
Joseph Meletiadis
(J)
Elizabeth De Kort
(E)
Luisa Verga
(L)
Laura Serrano
(L)
Nurettin Erben
(N)
Roberta Di Blasi
(R)
Athanasios Tragiannidis
(A)
José-María Ribera-Santa Susana
(JM)
Hans-Beier Ommen
(HB)
Alessandro Busca
(A)
Nicola Coppola
(N)
Rui Bergantim
(R)
Giulia Dragonetti
(G)
Marianna Criscuolo
(M)
Luana Fianchi
(L)
Matteo Bonanni
(M)
Andrés Soto-Silva
(A)
Malgorzata Mikulska
(M)
Marina Machado
(M)
Chi Shan Kho
(C)
Nazia Hassan
(N)
Eleni Gavriilaki
(E)
Gregorio Cordini
(G)
Louis Yi Ann Chi
(LYA)
Matthias Eggerer
(M)
Martin Hoenigl
(M)
Juergen Prattes
(J)
María-Josefa Jiménez-Lorenzo
(MJ)
Sofia Zompi
(S)
Giovanni Paolo Maria Zambrotta
(GPM)
Gökçe Melis Çolak
(GM)
Nicole García-Poutón
(N)
Tommaso Francesco Aiello
(TF)
Romane Prin
(R)
Maria Stamouli
(M)
Michail Samarkos
(M)
Informations de copyright
© 2023 The Author(s).
Déclaration de conflit d'intérêts
The authors do not declare conflicts of interest related to the submitted manuscript. The funder of the study had no role in study design, data analysis, interpretation, or writing of the report. All authors had full access to the data and had final responsibility for the decision to submit for publication.
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