Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry

Standard

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

In: ECLINICALMEDICINE, Vol. 58, 04.2023, p. 101939.

Research output: SCORING: Contribution to journalSCORING: Journal articleResearchpeer-review

Harvard

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, G-A, 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, J-Á, 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 2023, 'Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry', ECLINICALMEDICINE, vol. 58, pp. 101939. https://doi.org/10.1016/j.eclinm.2023.101939

APA

Salmanton-García, J., Marchesi, F., Gomes da Silva, M., Farina, F., Dávila-Valls, J., Bilgin, Y. M., 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, G-A., Meers, S., Itri, F., ... EPICOVIDEHA registry (2023). Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry. ECLINICALMEDICINE, 58, 101939. https://doi.org/10.1016/j.eclinm.2023.101939

Vancouver

Salmanton-García J, Marchesi F, Gomes da Silva M, Farina F, Dávila-Valls J, Bilgin YM et al. Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry. ECLINICALMEDICINE. 2023 Apr;58:101939. https://doi.org/10.1016/j.eclinm.2023.101939

Bibtex

@article{116d0515aad1447b9e6303fb17b469d1,
title = "Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry",
abstract = "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).",
author = "Jon Salmanton-Garc{\'i}a and Francesco Marchesi and {Gomes da Silva}, Maria and Francesca Farina and Julio D{\'a}vila-Valls and Bilgin, {Yavuz M} and Andreas Glenth{\o}j and Iker Falces-Romero and {Van Doesum}, Jaap and Jorge Labrador and Caterina Buquicchio and Shaimaa El-Ashwah and Verena Petzer and {Van Praet}, Jens and Martin Sch{\"o}nlein and Michelina Dargenio and Gustavo-Adolfo M{\'e}ndez and Stef Meers and Federico Itri and Antonio Giordano and Pincz{\'e}s, {L{\'a}szl{\'o} Imre} and Ildefonso Espigado and Zlate Stojanoski and Alberto L{\'o}pez-Garc{\'i}a and Lucia Prezioso and Ozren Jaksic and Antonio Vena and Fracchiolla, {Nicola S} and Gonz{\'a}lez-L{\'o}pez, {Tom{\'a}s Jos{\'e}} and Natasa Colovi{\'c} and Mario Delia and Barbora Weinbergerov{\'a} and Monia Marchetti and {Marques de Almeida}, Joyce and Olimpia Finizio and Caroline Besson and Biernat, {Monika M} and Toni Valkovi{\'c} and Tobias Lahmer and Annarosa Cuccaro and Irati Ormazabal-V{\'e}lez and Josip Batini{\'c} and Noem{\'i} Fern{\'a}ndez and {De Jonge}, Nick and Carlo Tascini and Anastasopoulou, {Amalia N} and R{\'e}my Dul{\'e}ry and {Del Principe}, {Maria Ilaria} and Ga{\"e}tan Plantefeve and Papa, {Mario Virgilio} and Marcio Nucci and Moraima Jim{\'e}nez and Avinash Aujayeb and Jos{\'e}-{\'A}ngel Hern{\'a}ndez-Rivas and Maria Merelli and Chiara Cattaneo and Ola Blennow and Anna Nordlander and Alba Cabirta and Gina Varricchio and Sacchi, {Maria Vittoria} and Raul Cordoba and Elena Arellano and Gr{\"a}fe, {Stefanie K} and Dominik Wolf and Ziad Emarah and Emanuele Ammatuna and Hersby, {Ditte Stampe} and Sonia Mart{\'i}n-P{\'e}rez and {Nunes Rodrigues}, Raquel and Laman Rahimli and Livio Pagano and Cornely, {Oliver A} and {EPICOVIDEHA registry}",
note = "{\textcopyright} 2023 The Author(s).",
year = "2023",
month = apr,
doi = "10.1016/j.eclinm.2023.101939",
language = "English",
volume = "58",
pages = "101939",
journal = "ECLINICALMEDICINE",
issn = "2589-5370",
publisher = "Lancet Publishing Group",

}

RIS

TY - JOUR

T1 - Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the 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 - Papa, Mario Virgilio

AU - Nucci, Marcio

AU - Jiménez, Moraima

AU - Aujayeb, Avinash

AU - Hernández-Rivas, José-Ángel

AU - Merelli, Maria

AU - Cattaneo, Chiara

AU - Blennow, Ola

AU - Nordlander, Anna

AU - Cabirta, Alba

AU - Varricchio, Gina

AU - Sacchi, Maria Vittoria

AU - Cordoba, Raul

AU - Arellano, Elena

AU - Gräfe, Stefanie K

AU - Wolf, Dominik

AU - Emarah, Ziad

AU - Ammatuna, Emanuele

AU - Hersby, Ditte Stampe

AU - Martín-Pérez, Sonia

AU - Nunes Rodrigues, Raquel

AU - Rahimli, Laman

AU - Pagano, Livio

AU - Cornely, Oliver A

AU - EPICOVIDEHA registry

N1 - © 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).

U2 - 10.1016/j.eclinm.2023.101939

DO - 10.1016/j.eclinm.2023.101939

M3 - SCORING: Journal article

C2 - 37041967

VL - 58

SP - 101939

JO - ECLINICALMEDICINE

JF - ECLINICALMEDICINE

SN - 2589-5370

ER -