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

Jon Salmanton-García; Francesco Marchesi; Maria Gomes da Silva; Francesca Farina; Julio Dávila-Valls; Yavuz M Bilgin; Andreas Glenthøj; Iker Falces-Romero; Jaap Van Doesum; Jorge Labrador; Caterina Buquicchio; Shaimaa El-Ashwah; Verena Petzer; Jens Van Praet; Martin Schönlein; Michelina Dargenio; Gustavo-Adolfo Méndez; Stef Meers; Federico Itri; Antonio Giordano; László Imre Pinczés; Ildefonso Espigado; Zlate Stojanoski; Alberto López-García; Lucia Prezioso; Ozren Jaksic; Antonio Vena; Nicola S Fracchiolla; Tomás José González-López; Natasa Colović; Mario Delia; Barbora Weinbergerová; Monia Marchetti; Joyce Marques de Almeida; Olimpia Finizio; Caroline Besson; Monika M Biernat; Toni Valković; Tobias Lahmer; Annarosa Cuccaro; Irati Ormazabal-Vélez; Josip Batinić; Noemí Fernández; Nick De Jonge; Carlo Tascini; Amalia N Anastasopoulou; Rémy Duléry; Maria Ilaria Del Principe; Gaëtan Plantefeve; Ditte Stampe Hersby; EPICOVIDEHA registry

doi:10.1016/j.eclinm.2023.101939

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

Jon Salmanton-García^*, Francesco Marchesi, Maria Gomes da Silva, Francesca Farina, Julio Dávila-Valls, Yavuz M Bilgin, Andreas Glenthøj, Iker Falces-Romero, Jaap Van Doesum, Jorge Labrador, Caterina Buquicchio, Shaimaa El-Ashwah, Verena Petzer, Jens Van Praet, Martin Schönlein, Michelina Dargenio, Gustavo-Adolfo Méndez, Stef Meers, Federico Itri, Antonio GiordanoLászló Imre Pinczés, Ildefonso Espigado, Zlate Stojanoski, Alberto López-García, Lucia Prezioso, Ozren Jaksic, Antonio Vena, Nicola S Fracchiolla, Tomás José González-López, Natasa Colović, Mario Delia, Barbora Weinbergerová, Monia Marchetti, Joyce Marques de Almeida, Olimpia Finizio, Caroline Besson, Monika M Biernat, Toni Valković, Tobias Lahmer, Annarosa Cuccaro, Irati Ormazabal-Vélez, Josip Batinić, Noemí Fernández, Nick De Jonge, Carlo Tascini, Amalia N Anastasopoulou, Rémy Duléry, Maria Ilaria Del Principe, Gaëtan Plantefeve, Ditte Stampe Hersby, EPICOVIDEHA registry

^*Corresponding author af dette arbejde

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23 Citationer (Scopus)

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).

Originalsprog	Engelsk
Artikelnummer	101939
Tidsskrift	EClinicalMedicine
Vol/bind	58
ISSN	2589-5370
DOI	https://doi.org/10.1016/j.eclinm.2023.101939
Status	Udgivet - apr. 2023

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10.1016/j.eclinm.2023.101939

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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, Artikel 101939. https://doi.org/10.1016/j.eclinm.2023.101939

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, Hersby, DS & EPICOVIDEHA registry 2023, 'Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry', EClinicalMedicine, bind 58, 101939. https://doi.org/10.1016/j.eclinm.2023.101939

@article{0a22a7aa784c420cb52167ff8aa95823,

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 Hersby, {Ditte Stampe} and {EPICOVIDEHA registry}",

note = "{\textcopyright} 2023 The Author(s).",

year = "2023",

month = apr,

doi = "10.1016/j.eclinm.2023.101939",

language = "English",

volume = "58",

journal = "EClinicalMedicine",

issn = "2589-5370",

publisher = "Lancet Publishing Group",

}

TY - JOUR

T1 - Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies

T2 - 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 - Hersby, Ditte Stampe

AU - EPICOVIDEHA registry

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).

UR - http://www.scopus.com/inward/record.url?scp=85151507775&partnerID=8YFLogxK

U2 - 10.1016/j.eclinm.2023.101939

DO - 10.1016/j.eclinm.2023.101939

M3 - Journal article

C2 - 37041967

SN - 2589-5370

VL - 58

JO - EClinicalMedicine

JF - EClinicalMedicine

M1 - 101939

ER -

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

Abstract

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