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

J 2023

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

SALMANTON-GARCIA, Jon, Francesco MARCHESI, da Silva Maria GOMES, Francesca FARINA, Julio DAVILA-VALLS et. al.

Basic information

Original name

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

Authors

SALMANTON-GARCIA, Jon, Francesco MARCHESI, da Silva Maria GOMES, Francesca FARINA, Julio DAVILA-VALLS, Yavuz M BILGIN, Andreas GLENTHOJ, Iker FALCES-ROMERO, Van Doesum JAAP, Jorge LABRADOR, Caterina BUQUICCHIO, Shaimaa EL-ASHWAH, Verena PETZER, Van Praet JENS, Martin SCHOENLEIN, Michelina DARGENIO, Gustavo-Adolfo MENDEZ, Stef MEERS, Federico ITRI, Antonio GIORDANO, Laszlo Imre PINCZES, Ildefonso ESPIGADO, Zlate STOJANOSKI, Alberto LOPEZ-GARCIA, Lucia PREZIOSO, Ozren JAKSIC, Antonio VENA, Nicola S FRACCHIOLLA, Tomas Jose GONZALEZ-LOPEZ, Natasa COLOVIC, Mario DELIA, Barbora WEINBERGEROVÁ (203 Czech Republic, belonging to the institution), Monia MARCHETTI, de Almeida Joyce MARQUES, Olimpia FINIZIO, Caroline BESSON, Monika M BIERNAT, Toni VALKOVIC, Tobias LAHMER, Annarosa CUCCARO, Irati ORMAZABAL-VELEZ, Josip BATINIC, Noemi FERNANDEZ, De Jonge NICK, Carlo TASCINI, Amalia N ANASTASOPOULOU, Remy DULERY, Del Principe Maria ILARIA, Gaetan PLANTEFEVE, Mario Virgilio PAPA, Marcio NUCCI, Moraima JIMENEZ, Avinash AUJAYEB, Jose-angel HERNANDEZ-RIVAS, Maria MERELLI, Chiara CATTANEO, Ola BLENNOW, Anna NORDLANDER, Alba CABIRTA, Gina VARRICCHIO, Maria Vittoria SACCHI, Raul CORDOBA, Elena ARELLANO, Stefanie K GRAFE, Dominik WOLF, Ziad EMARAH, Emanuele AMMATUNA, Ditte Stampe HERSBY, Sonia MARTIN-PEREZ, Raquel Nunes RODRIGUES, Laman RAHIMLI, Livio PAGANO and Oliver A CARTNEY

Edition

EClinicalMedicine, AMSTERDAM, ELSEVIER, 2023, 2589-5370

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30205 Hematology

Country of publisher

Netherlands

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 15.100 in 2022

RIV identification code

RIV/00216224:14110/23:00133408

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.eclinm.2023.101939

UT WoS

000999279400001

Keywords in English

Nirmatrelvir; SARS-CoV-2; Haematology; Malignancy; COVID-19

Abstract

V originále

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 pa-tients 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 Asso-ciated Research Extension) COVID-19 RFP program by GILEAD Science, United States (Project 2020-8223). Copyright (c) 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Citovat

SALMANTON-GARCIA, Jon, Francesco MARCHESI, da Silva Maria GOMES, Francesca FARINA, Julio DAVILA-VALLS, Yavuz M BILGIN, Andreas GLENTHOJ, Iker FALCES-ROMERO, Van Doesum JAAP, Jorge LABRADOR, Caterina BUQUICCHIO, Shaimaa EL-ASHWAH, Verena PETZER, Van Praet JENS, Martin SCHOENLEIN, Michelina DARGENIO, Gustavo-Adolfo MENDEZ, Stef MEERS, Federico ITRI, Antonio GIORDANO, Laszlo Imre PINCZES, Ildefonso ESPIGADO, Zlate STOJANOSKI, Alberto LOPEZ-GARCIA, Lucia PREZIOSO, Ozren JAKSIC, Antonio VENA, Nicola S FRACCHIOLLA, Tomas Jose GONZALEZ-LOPEZ, Natasa COLOVIC, Mario DELIA, Barbora WEINBERGEROVÁ, Monia MARCHETTI, de Almeida Joyce MARQUES, Olimpia FINIZIO, Caroline BESSON, Monika M BIERNAT, Toni VALKOVIC, Tobias LAHMER, Annarosa CUCCARO, Irati ORMAZABAL-VELEZ, Josip BATINIC, Noemi FERNANDEZ, De Jonge NICK, Carlo TASCINI, Amalia N ANASTASOPOULOU, Remy DULERY, Del Principe Maria ILARIA, Gaetan PLANTEFEVE, Mario Virgilio PAPA, Marcio NUCCI, Moraima JIMENEZ, Avinash AUJAYEB, Jose-angel HERNANDEZ-RIVAS, Maria MERELLI, Chiara CATTANEO, Ola BLENNOW, Anna NORDLANDER, Alba CABIRTA, Gina VARRICCHIO, Maria Vittoria SACCHI, Raul CORDOBA, Elena ARELLANO, Stefanie K GRAFE, Dominik WOLF, Ziad EMARAH, Emanuele AMMATUNA, Ditte Stampe HERSBY, Sonia MARTIN-PEREZ, Raquel Nunes RODRIGUES, Laman RAHIMLI, Livio PAGANO and Oliver A CARTNEY. Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry. EClinicalMedicine. AMSTERDAM: ELSEVIER, 2023, vol. 58, April 2023, p. 1-19. ISSN 2589-5370. Available from: https://dx.doi.org/10.1016/j.eclinm.2023.101939.

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   author = {SalmantonandGarcia, Jon and Marchesi, Francesco and Gomes, da Silva Maria and Farina, Francesca and DavilaandValls, Julio and Bilgin, Yavuz M and Glenthoj, Andreas and FalcesandRomero, Iker and Jaap, Van Doesum and Labrador, Jorge and Buquicchio, Caterina and ElandAshwah, Shaimaa and Petzer, Verena and Jens, Van Praet and Schoenlein, Martin and Dargenio, Michelina and Mendez, GustavoandAdolfo and Meers, Stef and Itri, Federico and Giordano, Antonio and Pinczes, Laszlo Imre and Espigado, Ildefonso and Stojanoski, Zlate and LopezandGarcia, Alberto and Prezioso, Lucia and Jaksic, Ozren and Vena, Antonio and Fracchiolla, Nicola S and GonzalezandLopez, Tomas Jose and Colovic, Natasa and Delia, Mario and Weinbergerová, Barbora and Marchetti, Monia and Marques, de Almeida Joyce and Finizio, Olimpia and Besson, Caroline and Biernat, Monika M and Valkovic, Toni and Lahmer, Tobias and Cuccaro, Annarosa and OrmazabalandVelez, Irati and Batinic, Josip and Fernandez, Noemi and Nick, De Jonge and Tascini, Carlo and Anastasopoulou, Amalia N and Dulery, Remy and Ilaria, Del Principe Maria and Plantefeve, Gaetan and Papa, Mario Virgilio and Nucci, Marcio and Jimenez, Moraima and Aujayeb, Avinash and HernandezandRivas, Joseandangel and Merelli, Maria and Cattaneo, Chiara and Blennow, Ola and Nordlander, Anna and Cabirta, Alba and Varricchio, Gina and Sacchi, Maria Vittoria and Cordoba, Raul and Arellano, Elena and Grafe, Stefanie K and Wolf, Dominik and Emarah, Ziad and Ammatuna, Emanuele and Hersby, Ditte Stampe and MartinandPerez, Sonia and Rodrigues, Raquel Nunes and Rahimli, Laman and Pagano, Livio and Cartney, Oliver A},
   article_location = {AMSTERDAM},
   article_number = {April 2023},
   doi = {http://dx.doi.org/10.1016/j.eclinm.2023.101939},
   keywords = {Nirmatrelvir; SARS-CoV-2; Haematology; Malignancy; COVID-19},
   language = {eng},
   issn = {2589-5370},
   journal = {EClinicalMedicine},
   title = {Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry},
   url = {https://www.sciencedirect.com/science/article/pii/S2589537023001165?via%3Dihub},
   volume = {58},
   year = {2023}
}

TY  - JOUR
ID  - 2368980
AU  - Salmanton-Garcia, Jon - Marchesi, Francesco - Gomes, da Silva Maria - Farina, Francesca - Davila-Valls, Julio - Bilgin, Yavuz M - Glenthoj, Andreas - Falces-Romero, Iker - Jaap, Van Doesum - Labrador, Jorge - Buquicchio, Caterina - El-Ashwah, Shaimaa - Petzer, Verena - Jens, Van Praet - Schoenlein, Martin - Dargenio, Michelina - Mendez, Gustavo-Adolfo - Meers, Stef - Itri, Federico - Giordano, Antonio - Pinczes, Laszlo Imre - Espigado, Ildefonso - Stojanoski, Zlate - Lopez-Garcia, Alberto - Prezioso, Lucia - Jaksic, Ozren - Vena, Antonio - Fracchiolla, Nicola S - Gonzalez-Lopez, Tomas Jose - Colovic, Natasa - Delia, Mario - Weinbergerová, Barbora - Marchetti, Monia - Marques, de Almeida Joyce - Finizio, Olimpia - Besson, Caroline - Biernat, Monika M - Valkovic, Toni - Lahmer, Tobias - Cuccaro, Annarosa - Ormazabal-Velez, Irati - Batinic, Josip - Fernandez, Noemi - Nick, De Jonge - Tascini, Carlo - Anastasopoulou, Amalia N - Dulery, Remy - Ilaria, Del Principe Maria - Plantefeve, Gaetan - Papa, Mario Virgilio - Nucci, Marcio - Jimenez, Moraima - Aujayeb, Avinash - Hernandez-Rivas, Jose-angel - Merelli, Maria - Cattaneo, Chiara - Blennow, Ola - Nordlander, Anna - Cabirta, Alba - Varricchio, Gina - Sacchi, Maria Vittoria - Cordoba, Raul - Arellano, Elena - Grafe, Stefanie K - Wolf, Dominik - Emarah, Ziad - Ammatuna, Emanuele - Hersby, Ditte Stampe - Martin-Perez, Sonia - Rodrigues, Raquel Nunes - Rahimli, Laman - Pagano, Livio - Cartney, Oliver A
PY  - 2023
TI  - Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry
JF  - EClinicalMedicine
VL  - 58
IS  - April 2023
SP  - 1-19
EP  - 1-19
PB  - ELSEVIER
SN  - 25895370
KW  - Nirmatrelvir
KW  - SARS-CoV-2
KW  - Haematology
KW  - Malignancy
KW  - COVID-19
UR  - https://www.sciencedirect.com/science/article/pii/S2589537023001165?via%3Dihub
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 pa-tients 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 Asso-ciated Research Extension) COVID-19 RFP program by GILEAD Science, United States (Project 2020-8223). Copyright (c) 2023 The Author(s). Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
ER  -

SALMANTON-GARCIA, Jon, Francesco MARCHESI, da Silva Maria GOMES, Francesca FARINA, Julio DAVILA-VALLS, Yavuz M BILGIN, Andreas GLENTHOJ, Iker FALCES-ROMERO, Van Doesum JAAP, Jorge LABRADOR, Caterina BUQUICCHIO, Shaimaa EL-ASHWAH, Verena PETZER, Van Praet JENS, Martin SCHOENLEIN, Michelina DARGENIO, Gustavo-Adolfo MENDEZ, Stef MEERS, Federico ITRI, Antonio GIORDANO, Laszlo Imre PINCZES, Ildefonso ESPIGADO, Zlate STOJANOSKI, Alberto LOPEZ-GARCIA, Lucia PREZIOSO, Ozren JAKSIC, Antonio VENA, Nicola S FRACCHIOLLA, Tomas Jose GONZALEZ-LOPEZ, Natasa COLOVIC, Mario DELIA, Barbora WEINBERGEROVÁ, Monia MARCHETTI, de Almeida Joyce MARQUES, Olimpia FINIZIO, Caroline BESSON, Monika M BIERNAT, Toni VALKOVIC, Tobias LAHMER, Annarosa CUCCARO, Irati ORMAZABAL-VELEZ, Josip BATINIC, Noemi FERNANDEZ, De Jonge NICK, Carlo TASCINI, Amalia N ANASTASOPOULOU, Remy DULERY, Del Principe Maria ILARIA, Gaetan PLANTEFEVE, Mario Virgilio PAPA, Marcio NUCCI, Moraima JIMENEZ, Avinash AUJAYEB, Jose-angel HERNANDEZ-RIVAS, Maria MERELLI, Chiara CATTANEO, Ola BLENNOW, Anna NORDLANDER, Alba CABIRTA, Gina VARRICCHIO, Maria Vittoria SACCHI, Raul CORDOBA, Elena ARELLANO, Stefanie K GRAFE, Dominik WOLF, Ziad EMARAH, Emanuele AMMATUNA, Ditte Stampe HERSBY, Sonia MARTIN-PEREZ, Raquel Nunes RODRIGUES, Laman RAHIMLI, Livio PAGANO and Oliver A CARTNEY. Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry. \textit{EClinicalMedicine}. AMSTERDAM: ELSEVIER, 2023, vol.~58, April 2023, p.~1-19. ISSN~2589-5370. Available from: https://dx.doi.org/10.1016/j.eclinm.2023.101939.

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