TY - JOUR
T1 - Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies
T2 - a report from the EPICOVIDEHA registry
AU - EPICOVIDEHA registry
AU - Salmanton-García, Jon
AU - Marchesi, Francesco
AU - Gomes da Silva, Maria
AU - Farina, Francesca
AU - Dávila-Valls, Julio
AU - Bilgin, Yavuz M.
AU - Glenthøj, Andreas
AU - Falces-Romero, Iker
AU - Van Doesum, Jaap
AU - Labrador, Jorge
AU - Buquicchio, Caterina
AU - El-Ashwah, Shaimaa
AU - Petzer, Verena
AU - Van Praet, Jens
AU - Schönlein, Martin
AU - Dargenio, Michelina
AU - Méndez, Gustavo Adolfo
AU - Meers, Stef
AU - Itri, Federico
AU - Giordano, Antonio
AU - Pinczés, László Imre
AU - Espigado, Ildefonso
AU - Stojanoski, Zlate
AU - López-García, Alberto
AU - Prezioso, Lucia
AU - Jaksic, Ozren
AU - Vena, Antonio
AU - Fracchiolla, Nicola S.
AU - González-López, Tomás José
AU - Colović, Natasa
AU - Delia, Mario
AU - Weinbergerová, Barbora
AU - Marchetti, Monia
AU - Marques de Almeida, Joyce
AU - Finizio, Olimpia
AU - Besson, Caroline
AU - Biernat, Monika M.
AU - Valković, Toni
AU - Lahmer, Tobias
AU - Cuccaro, Annarosa
AU - Ormazabal-Vélez, Irati
AU - Batinić, Josip
AU - Fernández, Noemí
AU - De Jonge, Nick
AU - Tascini, Carlo
AU - Anastasopoulou, Amalia N.
AU - Duléry, Rémy
AU - Del Principe, Maria Ilaria
AU - Plantefeve, Gaëtan
AU - Ammatuna, Emanuele
N1 - Funding Information:
The authors thank all participating institutions for their utmost contributions and support to the project during a pandemic situation. In addition, we would like to express our gratitude to Professor Francisco Javier Martín-Vallejo (Department of Statistics, Faculty of Medicine, University of Salamanca, Salamanca, Spain) for his guidance in performing the statistical analyses of this manuscript. 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 ).
Publisher Copyright:
© 2023 The Author(s)
PY - 2023/4
Y1 - 2023/4
N2 - Background: 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: 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: 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: 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: 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).
AB - Background: 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: 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: 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: 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: 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).
KW - COVID-19
KW - Haematology
KW - Malignancy
KW - Nirmatrelvir
KW - SARS-CoV-2
U2 - 10.1016/j.eclinm.2023.101939
DO - 10.1016/j.eclinm.2023.101939
M3 - Article
AN - SCOPUS:85151507775
SN - 2589-5370
VL - 58
JO - EClinicalMedicine
JF - EClinicalMedicine
M1 - 101939
ER -