Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry.
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Salmanton-García Jon, Marchesi Francesco, Gomes da Silva Maria, Farina Francesca, Dávila-Valls Julio, Bilgin Yavuz M, Glenthøj Andreas, Falces-Romero Iker, Van Doesum Jaap, Labrador Jorge, Buquicchio Caterina, El-Ashwah Shaimaa, Petzer Verena, Van Praet Jens, Schönlein Martin, Dargenio Michelina, Méndez Gustavo-Adolfo, Meers Stef, Itri Federico, Giordano Antonio, Pinczés László Imre, Espigado Ildefonso, Stojanoski Zlate, López-García Alberto, Prezioso Lucia, Jaksic Ozren, Vena Antonio, Fracchiolla Nicola S, González-López Tomás José, Colović Natasa, Delia Mario, Weinbergerová Barbora, Marchetti Monia, Marques de Almeida Joyce, Finizio Olimpia, Besson Caroline, Biernat Monika M, Valković Toni, Lahmer Tobias, Cuccaro Annarosa, Ormazabal-Vélez Irati, Batinić Josip, Fernández Noemí, De Jonge Nick, Tascini Carlo, Anastasopoulou Amalia N, Duléry Rémy, Del Principe Maria Ilaria, Plantefeve Gaëtan, Papa Mario Virgilio, Nucci Marcio, Jiménez Moraima, Aujayeb Avinash, Hernández-Rivas José-Ángel, Merelli Maria, Cattaneo Chiara, Blennow Ola, Nordlander Anna, Cabirta Alba, Varricchio Gina, Sacchi Maria Vittoria, Cordoba Raul, Arellano Elena, Gräfe Stefanie K, Wolf Dominik, Emarah Ziad, Ammatuna Emanuele, Hersby Ditte Stampe, Martín-Pérez Sonia, Nunes Rodrigues Raquel, Rahimli Laman, Pagano Livio, Cornely Oliver A, EPICOVIDEHA registry
Аннотация
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).