Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry. (April 2023)

• Record Type: Journal Article
• Authors: 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.; Piukovics, Klára; De Ramón, Cristina; Danion, François; Yahya, Ayel; Guidetti, Anna; Garcia-Vidal, Carolina; Sili, Uluhan; Meletiadis, Joseph; De Kort, Elizabeth; Verga, Luisa; Serrano, Laura; Erben, Nurettin; Di Blasi, Roberta; Tragiannidis, Athanasios; Ribera-Santa Susana, José-María; Ommen, Hans-Beier; Busca, Alessandro; Coppola, Nicola; Bergantim, Rui; Dragonetti, Giulia; Criscuolo, Marianna; Fianchi, Luana; Bonanni, Matteo; Soto-Silva, Andrés; Mikulska, Malgorzata; Machado, Marina; Shan Kho, Chi; Hassan, Nazia; Gavriilaki, Eleni; Cordini, Gregorio; Chi, Louis Yi Ann; Eggerer, Matthias; Hoenigl, Martin; Prattes, Juergen; Jiménez-Lorenzo, María-Josefa; Zompi, Sofia; Zambrotta, Giovanni Paolo Maria; Çolak, Gökçe Melis; García-Poutón, Nicole; Aiello, Tommaso Francesco; Prin, Romane; Stamouli, Maria; Samarkos, Michail;
• Is Part Of: EClinicalMedicine. Volume 58(2023)
• Publication Date: 2023-04
• Subjects: Nirmatrelvir -- SARS-CoV-2 -- Haematology -- Malignancy -- COVID-19; Medicine -- Research -- Periodicals; Medical policy -- Periodicals; Clinical Medicine; Health Policy; Public Health; Medical policy; Medicine -- Research; Periodical; Electronic journals; Periodicals; 613
• DOI: 10.1016/j.eclinm.2023.101939
• Languages: English
• ISSNs: 2589-5370

Abstract

Summary: 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 ).