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1. Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies

Author

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., Registry, EPICOVIDEHA, 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, Hematology, Institut Català de la Salut, [Salmanton-García J] University of Cologne, Faculty of Medicine, and University Hospital Cologne, Chair Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany. University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM), Cologne, Germany. German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne, Cologne, Germany. [Marchesi F] Hematology and Stem Cell Transplant Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy. [Gomes da Silva M] Portuguese Institute of Oncology, Lisbon, Portugal. [Farina F] IRCCS Ospedale San Raffaele, Milan, Italy. [Dávila-Valls J] Hospital Nuestra Señora de Sonsoles, Ávila, Spain. [Bilgin YM] Department of Internal Medicine, ADRZ, Goes, the Netherlands. [Jiménez M] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Sang - Càncer, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Other subheadings::Other subheadings::/drug therapy [Other subheadings], COVID-19 (Malaltia) - Tractament, Medicine and Health Sciences, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Medicaments antivírics - Ús terapèutic, Other subheadings::/therapeutic use [Other subheadings], 03.02. Klinikai orvostan, neoplasias::neoplasias por localización::neoplasias hematológicas [ENFERMEDADES], BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences. Internal Medicine, BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti. Interna medicina, Otros calificadores::/uso terapéutico [Otros calificadores], SARS-CoV-2, COVID-19, Malignancy, Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], General Medicine, Neoplasms::Neoplasms by Site::Hematologic Neoplasms [DISEASES], BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences. Infectology, Settore MED/15, Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents [CHEMICALS AND DRUGS], Settore MED/15 - MALATTIE DEL SANGUE, acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos [COMPUESTOS QUÍMICOS Y DROGAS], BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti. Infektologija, Haematology, Nirmatrelvir
Abstract

COVID-19; Haematology; Nirmatrelvir COVID-19; Hematología; Nirmatrelvir COVID-19; Hematologia; Nirmatrelvir 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. 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).

Published
2023
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2. Outcome of COVID-19 in allogeneic stem cell transplant recipients: Results from the EPICOVIDEHA registry

Author

Busca, Alessandro, Salmanton-García, Jon, Marchesi, Francesco, Farina, Francesca, Seval, Guldane Cengiz, Van Doesum, Jaap, De Jonge, Nick, Bahr, Nathan C., Maertens, Johan, Meletiadis, Joseph, Fracchiolla, Nicola S., Weinbergerová, Barbora, Verga, Luisa, Ráčil, Zdeněk, Jiménez, Moraima, Glenthøj, Andreas, Blennow, Ola, Tanase, Alina Daniela, Schönlein, Martin, Prezioso, Lucia, Khanna, Nina, Duarte, Rafael F., Žák, Pavel, Nucci, Marcio, Machado, Marina, Kulasekararaj, Austin, Espigado, Ildefonso, De Kort, Elizabeth, Ribera-Santa Susana, José-María, Marchetti, Monia, Magliano, Gabriele, Falces-Romero, Iker, Ilhan, Osman, Ammatuna, Emanuele, Zompi, Sofia, Tsirigotis, Panagiotis, Antoniadou, Anastasia, Zambrotta, Giovanni Paolo Maria, Nordlander, Anna, Karlsson, Linda Katharina, Hanakova, Michaela, Dragonetti, Giulia, Cabirta, Alba, Berg Venemyr, Caroline, Gräfe, Stefanie, Van Praet, Jens, Tragiannidis, Athanasios, Petzer, Verena, López-García, Alberto, Itri, Federico, Groh, Ana, Gavriilaki, Eleni, Dargenio, Michelina, Rahimli, Laman, Cornely, Oliver A., Pagano, Livio, EPICOVIDEHA Consortium, [missing], Hematology, Institut Català de la Salut, [Busca A] Stem Cell Transplant Center, AOU Citta’ della Salute e della Scienza, Turin, Italy. [Salmanton-García J] University of Cologne, Faculty of Medicine and University Hospital Cologne, Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany. University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Cologne, Germany. [Marchesi F] Hematology and Stem Cell Transplant Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy. [Farina F] IRCCS Ospedale San Raffaele, Milan, Italy. [Seval GC] Ankara University, Ankara, Türkiye. [Van Doesum J] University Medical Center Groningen, Groningen, Netherlands. [Jiménez M] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
hematological malignances, Cèl·lules mare hematopoètiques - Trasplantació, SARS-CoV-2, Hemic and Lymphatic Diseases::Hematologic Diseases [DISEASES], Immunology, allogeneic HSCT, Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], COVID-19 (Malaltia), COVID-19 infection, Cancer development and immune defence Radboud Institute for Health Sciences [Radboudumc 2], enfermedades hematológicas y linfáticas::enfermedades hematológicas [ENFERMEDADES], Settore MED/15 - MALATTIE DEL SANGUE, All institutes and research themes of the Radboud University Medical Center, Allogeneic HSCT, Sang - Malalties, immunocompromised patients, Medicine and Health Sciences, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Hematological malignances, Immunocompromised patients, Immunology and Allergy, Therapeutics::Biological Therapy::Cell- and Tissue-Based Therapy::Cell Transplantation::Stem Cell Transplantation::Hematopoietic Stem Cell Transplantation [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], terapéutica::terapia biológica::tratamientos basados en células y tejidos::trasplante de células::trasplante de células madre::trasplante de células madre hematopoyéticas [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS]
Abstract

COVID-19 infection; Hematological malignances; Immunocompromised patients Infecció per COVID-19; Neoplasies hematològiques; Pacients immunodeprimits Infección por COVID-19; Neoplasias hematológicas; Pacientes inmunodeprimidos Background: The outcome of COVID-19 in allogeneic hematopoietic stem cell transplantation (HSCT) recipients is almost uniformely considered poor. The aim of present study was to retrospectively analyse the outcome and risk factors for mortality in a large series of patients who developed COVID-19 infection after an allogeneic HSCT. Methods: This multicenter retrospective study promoted by the European Hematology Association – Infections in Hematology Study Working Group, included 326 adult HSCT patients who had COVID-19 between January 2020 and March 2022. Results: The median time from HSCT to the diagnosis of COVID-19 was 268 days (IQR 86-713; range 0-185 days). COVID-19 severity was mild in 21% of the patients, severe in 39% and critical in 16% of the patients. In multivariable analysis factors associated with a higher risk of mortality were, age above 50 years, presence of 3 or more comorbidities, active hematologic disease at time of COVID-19 infection, development of COVID-19 within 12 months of HSCT, and severe/critical infections. Overall mortality rate was 21% (n=68): COVID-19 was the main or secondary cause of death in 16% of the patients (n=53). Conclusions: Mortality in HSCT recipients who develop COVID-19 is high and largely dependent on age, comorbidities, active hematologic disease, timing from transplant and severity of the infection. EPICOVIDEHA has received funds from Optics COMMITTM (COVID-19 Unmet Medical Needs and Associated Research Extension) COVID-19 RFP program by GILEAD Science, United States (Project 2020-8223). The funder of the study had no role in study design, data analysis, interpretation, or writing of the report. All authors had full access to the data and had final responsibility for the decision to submit for publication.

Published
2023
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3. COVID-19 in adult acute myeloid leukemia patients: a long-term followup study from the European Hematology Association survey (EPICOVIDEHA)

Author

Marchesi, Francesco, Salmanton-García, Jon, Emarah, Ziad, Piukovics, Klára, Nucci, Marcio, López-García, Alberto, Rácil, Zdenék, Farina, Francesca, Popova, Marina, Zompi, Sofia, Audisio, Ernesta, Ledoux, Marie-Pierre, Verga, Luisa, Weinbergerová, Barbora, Szotkovski, Tomas, Da Silva, Maria Gomes, Fracchiolla, Nicola, De Jonge, Nick, Collins, Graham, Marchetti, Monia, Magliano, Gabriele, Garcia-Vidal, Carolina, Biernat, Monika M., Van Doesum, Jaap, Machado, Marina, Demirkan, Fatih, Al-Khabori, Murtadha, Žák, Pavel, Víšek, Benjamín, Stoma, Igor, Méndez, Gustavo-Adolfo, Maertens, Johan, Khanna, Nina, Espigado, Ildefonso, Dragonetti, Giulia, Fianchi, Luana, Del Principe, Maria Ilaria, Cabirta, Alba, Ormazabal-Vélez, Irati, Jakšić, Ozren, Buquicchio, Caterina, Bonuomo, Valentina, Batinié, Josip, Omrani, Ali S., Lamure, Sylvain, Finizio, Olimpia, Fernández, Noemí, Falces-Romero, Iker, Blennow, Ola, Bergantim, Rui, Ali, Natasha, Win, Sein, Van Praet, Jens, Tisi, Maria Chiara, Shirinova, Ayten, Schönlein, Martin, Prattes, Juergen, Piedimonte, Monica, Petzer, Verena, Navrátil, Milan, Kulasekararaj, Austin, Jindra, Pavel, Sramek, Jirí, Glenthøj, Andreas, Fazzi, Rita, De Ramón-Sánchez, Cristina, Cattaneo, Chiara, Calbacho, Maria, Bahr, Nathan C., El-Ashwah, Shaimaa, Cordoba, Raul, Hanakova, Michaela, Zambrotta, Giovanni, Sciumè, Mariarita, Booth, Stephen, Rodrigues, Raquel Nunes, Sacchi, Maria Vittoria, García-Poutón, Nicole, Martín-González, Juan-Alberto, Khostelidi, Sofya, Gräfe, Stefanie, Rahimli, Laman, Ammatuna, Emanuele, Busca, Alessandro, Corradini, Paolo, Hoenigl, Martin, Klimko, Nikolai, Koehler, Philipp, Pagliuca, Antonio, Passamonti, Francesco, Cornely, Oliver A., Pagano, Livio, Universitat Autònoma de Barcelona, Institut Català de la Salut, [Marchesi F] Hematology and Stem Cell Transplant Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy. [Salmanton-García J] University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany. University of Cologne, Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM), Cologne, Germany. [Emarah Z] Oncology Center, Mansoura University, Mansoura, Egypt. [Piukovics K] Department of Internal Medicine, South Division Faculty of Medicine University of Szeged, Szeged, Hungary. [Nucci M] Department of Internal Medicine, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. [López-García A] Fundacion Jimenez Diaz University Hospital, Health Research Institute IIS-FJD, Madrid, Spain. [Cabirta A] Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Settore MED/15 - MALATTIE DEL SANGUE, Leucèmia mieloide aguda, neoplasias::neoplasias por tipo histológico::leucemia::leucemia mieloide::leucemia mieloide aguda::leucemia monocítica aguda [ENFERMEDADES], Medicine and Health Sciences, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], Hematology, Neoplasms::Neoplasms by Histologic Type::Leukemia::Leukemia, Myeloid::Leukemia, Myeloid, Acute::Leukemia, Monocytic, Acute [DISEASES], 03.02. Klinikai orvostan, Settore MED/15, Infection, COVID-19 (Malaltia), AML, COVID19
Abstract

COVID-19; Acute myeloid leukemia; Survey COVID-19; Leucemia mieloide aguda; Encuesta COVID-19; Leucèmia mieloide aguda; Enquesta Patients with acute myeloid leukemia (AML) are at high risk of dying from coronavirus disease 2019 (COVID-19). The optimal management of AML patients with COVID-19 has not been established. Our multicenter study included 388 adult AML patients diagnosed with COVID-19 between February 2020 and October 2021. The vast majority were receiving or had received AML treatment in the preceding 3 months. COVID-19 was severe in 41.2% and critical in 21.1% of cases. The chemotherapeutic schedule was modified in 174 patients (44.8%), delayed in 68 and permanently discontinued in 106. After a median follow-up of 325 days, 180 patients (46.4%) had died; death was attributed to COVID-19 (43.3%), AML (26.1%) or to a combination of both (26.7%), whereas in 3.9% of cases the reason was unknown. Active disease, older age, and treatment discontinuation were associated with death, whereas AML treatment delay was protective. Seventy-nine patients had a simultaneous AML and COVID-19 diagnosis, with better survival when AML treatment could be delayed (80%; P

Published
2022

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