Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry.
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Salmanton-García J, Marchesi F, Gomes da Silva M, Farina F, Dávila-Valls J, Bilgin YM, Glenthøj A, Falces-Romero I, Van Doesum J, Labrador J, Buquicchio C, El-Ashwah S, Petzer V, Van Praet J, Schönlein M, Dargenio M, Méndez GA, Meers S, Itri F, Giordano A, Pinczés LI, Espigado I, Stojanoski Z, López-García A, Prezioso L, Jaksic O, Vena A, Fracchiolla NS, González-López TJ, Colović N, Delia M, Weinbergerová B, Marchetti M, Marques de Almeida J, Finizio O, Besson C, Biernat MM, Valković T, Lahmer T, Cuccaro A, Ormazabal-Vélez I, Batinić J, Fernández N, De Jonge N, Tascini C, Anastasopoulou AN, Duléry R, Del Principe MI, Plantefeve G, Papa MV, Nucci M, Jiménez M, Aujayeb A, Hernández-Rivas JÁ, Merelli M, Cattaneo C, Blennow O, Nordlander A, Cabirta A, Varricchio G, Sacchi MV, Cordoba R, Arellano E, Gräfe SK, Wolf D, Emarah Z, Ammatuna E, Hersby DS, Martín-Pérez S, Nunes Rodrigues R, Rahimli L, Pagano L, Cornely OA, EPICOVIDEHA registry
EClinicalMedicine 58 (-) 101939 [2023-04-00; online 2023-04-06]
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).
PubMed 37041967
DOI 10.1016/j.eclinm.2023.101939
Crossref 10.1016/j.eclinm.2023.101939
pmc: PMC10078172
pii: S2589-5370(23)00116-5