Molnupiravir compared to nirmatrelvir/ritonavir for COVID-19 in high-risk patients with haematological malignancy in Europe. A matched-paired analysis from the EPICOVIDEHA registry
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Molnupiravir compared to nirmatrelvir/ritonavir for COVID-19 in high-risk patients with haematological malignancy in Europe. A matched-paired analysis from the EPICOVIDEHA registry. / Salmanton-García, Jon; Marchesi, Francesco; Koehler, Philipp; Weinbergerová, Barbora; Čolović, Natasa; Falces-Romero, Iker; Buquicchio, Caterina; Farina, Francesca; van Praet, Jens; Biernat, Monika M.; Itri, Federico; Prezioso, Lucia; Tascini, Carlo; Vena, Antonio; Romano, Alessandra; Delia, Mario; Dávila-Valls, Julio; Martín-Pérez, Sonia; Lavilla-Rubira, Esperanza; Adžić-vukičević, Tatjana; García-Bordallo, Daniel; López-García, Alberto; Criscuolo, Mariana; Petzer, Verena; Fracchiolla, Nicola S.; Espigado, Ildefonso; Sili, Uluhan; Meers, Stef; Erben, Nurettin; Cattaneo, Chiara; Tragiannidis, Athanasios; Gavriilaki, Eleni; Schönlein, Martin; Mitrovic, Mirjana; Pantic, Nikola; Merelli, Maria; Labrador, Jorge; Hernández-Rivas, José Ángel; Glenthøj, Andreas; Fouquet, Guillemette; del Principe, Maria Ilaria; Dargenio, Michelina; Calbacho, María; Besson, Caroline; Kohn, Milena; Gräfe, Stefanie; Hersby, Ditte Stampe; Arellano, Elena; Çolak, Gökçe Melis; Wolf, Dominik; Marchetti, Monia; Nordlander, Anna; Blennow, Ola; Cordoba, Raul; Mišković, Bojana; Mladenović, Miloš; Bavastro, Martina; Limongelli, Alessandro; Rahimli, Laman; Pagano, Livio; Cornely, Oliver A.
I: International Journal of Antimicrobial Agents, Bind 62, Nr. 4, 106952, 2023.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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T1 - Molnupiravir compared to nirmatrelvir/ritonavir for COVID-19 in high-risk patients with haematological malignancy in Europe. A matched-paired analysis from the EPICOVIDEHA registry
AU - Salmanton-García, Jon
AU - Marchesi, Francesco
AU - Koehler, Philipp
AU - Weinbergerová, Barbora
AU - Čolović, Natasa
AU - Falces-Romero, Iker
AU - Buquicchio, Caterina
AU - Farina, Francesca
AU - van Praet, Jens
AU - Biernat, Monika M.
AU - Itri, Federico
AU - Prezioso, Lucia
AU - Tascini, Carlo
AU - Vena, Antonio
AU - Romano, Alessandra
AU - Delia, Mario
AU - Dávila-Valls, Julio
AU - Martín-Pérez, Sonia
AU - Lavilla-Rubira, Esperanza
AU - Adžić-vukičević, Tatjana
AU - García-Bordallo, Daniel
AU - López-García, Alberto
AU - Criscuolo, Mariana
AU - Petzer, Verena
AU - Fracchiolla, Nicola S.
AU - Espigado, Ildefonso
AU - Sili, Uluhan
AU - Meers, Stef
AU - Erben, Nurettin
AU - Cattaneo, Chiara
AU - Tragiannidis, Athanasios
AU - Gavriilaki, Eleni
AU - Schönlein, Martin
AU - Mitrovic, Mirjana
AU - Pantic, Nikola
AU - Merelli, Maria
AU - Labrador, Jorge
AU - Hernández-Rivas, José Ángel
AU - Glenthøj, Andreas
AU - Fouquet, Guillemette
AU - del Principe, Maria Ilaria
AU - Dargenio, Michelina
AU - Calbacho, María
AU - Besson, Caroline
AU - Kohn, Milena
AU - Gräfe, Stefanie
AU - Hersby, Ditte Stampe
AU - Arellano, Elena
AU - Çolak, Gökçe Melis
AU - Wolf, Dominik
AU - Marchetti, Monia
AU - Nordlander, Anna
AU - Blennow, Ola
AU - Cordoba, Raul
AU - Mišković, Bojana
AU - Mladenović, Miloš
AU - Bavastro, Martina
AU - Limongelli, Alessandro
AU - Rahimli, Laman
AU - Pagano, Livio
AU - Cornely, Oliver A.
N1 - Publisher Copyright: © 2023 The Author(s)
PY - 2023
Y1 - 2023
N2 - Introduction: Molnupiravir and nirmatrelvir/ritonavir are antivirals used to prevent progression to severe SARS-CoV-2 infections and decrease hospitalisation and mortality rates. Nirmatrelvir/ritonavir was authorised in Europe in December 2021, whereas molnupiravir is not yet licensed in Europe as of February 2022. Molnupiravir may be an alternative to nirmatrelvir/ritonavir because it is associated with fewer drug-drug interactions and contraindications. A caveat for molnupiravir is the mode of action induces viral mutations. Mortality rate reduction with molnupiravir was less pronounced than that with nirmatrelvir/ritonavir in patients without haematological malignancy. Little is known about the comparative efficacy of the two drugs in patients with haematological malignancy at high-risk of severe COVID-19. Thus, molnupiravir and nirmatrelvir/ritonavir were compared in a cohort of patients with haematological malignancies. Methods: Clinical data from patients treated with molnupiravir or nirmatrelvir/ritonavir monotherapy for COVID-19 were retrieved from the EPICOVIDEHA registry. Patients treated with molnupiravir were matched by sex, age (±10 years), and severity of baseline haematological malignancy to controls treated with nirmatrelvir/ritonavir. Results: A total of 116 patients receiving molnupiravir for the clinical management of COVID-19 were matched to an equal number of controls receiving nirmatrelvir/ritonavir. In each of the groups, 68 (59%) patients were male; with a median age of 64 years (interquartile range [IQR] 53-74) for molnupiravir recipients and 64 years (IQR 54-73) for nirmatrelvir/ritonavir recipients; 56.9% (n=66) of the patients had controlled baseline haematological malignancy, 12.9% (n=15) had stable disease, and 30.2% (n=35) had active disease at COVID-19 onset in each group. During COVID-19 infection, one third of patients from each group were admitted to hospital. Although a similar proportion of patients in the two groups were vaccinated (molnupiravir n=77, 66% vs. nirmatrelvir/ritonavir n=87, 75%), more of those treated with nirmatrelvir/ritonavir had received four vaccine doses (n=27, 23%) compared with those treated with molnupiravir (n=5, 4%) (P<0.001). No differences were detected in COVID-19 severity (P=0.39) or hospitalisation (P=1.0). No statistically significant differences were identified in overall mortality rate (P=0.78) or survival probability (d30 P=0.19, d60 P=0.67, d90 P=0.68, last day of follow up P=0.68). Deaths were either attributed to COVID-19, or the infection was judged by the treating physician to have contributed to death. Conclusions: Hospitalisation and mortality rates with molnupiravir were comparable to those with nirmatrelvir/ritonavir in high-risk patients with haematological malignancies and COVID-19. Molnupiravir is a plausible alternative to nirmatrelvir/ritonavir for COVID-19 treatment in patients with haematological malignancy.
AB - Introduction: Molnupiravir and nirmatrelvir/ritonavir are antivirals used to prevent progression to severe SARS-CoV-2 infections and decrease hospitalisation and mortality rates. Nirmatrelvir/ritonavir was authorised in Europe in December 2021, whereas molnupiravir is not yet licensed in Europe as of February 2022. Molnupiravir may be an alternative to nirmatrelvir/ritonavir because it is associated with fewer drug-drug interactions and contraindications. A caveat for molnupiravir is the mode of action induces viral mutations. Mortality rate reduction with molnupiravir was less pronounced than that with nirmatrelvir/ritonavir in patients without haematological malignancy. Little is known about the comparative efficacy of the two drugs in patients with haematological malignancy at high-risk of severe COVID-19. Thus, molnupiravir and nirmatrelvir/ritonavir were compared in a cohort of patients with haematological malignancies. Methods: Clinical data from patients treated with molnupiravir or nirmatrelvir/ritonavir monotherapy for COVID-19 were retrieved from the EPICOVIDEHA registry. Patients treated with molnupiravir were matched by sex, age (±10 years), and severity of baseline haematological malignancy to controls treated with nirmatrelvir/ritonavir. Results: A total of 116 patients receiving molnupiravir for the clinical management of COVID-19 were matched to an equal number of controls receiving nirmatrelvir/ritonavir. In each of the groups, 68 (59%) patients were male; with a median age of 64 years (interquartile range [IQR] 53-74) for molnupiravir recipients and 64 years (IQR 54-73) for nirmatrelvir/ritonavir recipients; 56.9% (n=66) of the patients had controlled baseline haematological malignancy, 12.9% (n=15) had stable disease, and 30.2% (n=35) had active disease at COVID-19 onset in each group. During COVID-19 infection, one third of patients from each group were admitted to hospital. Although a similar proportion of patients in the two groups were vaccinated (molnupiravir n=77, 66% vs. nirmatrelvir/ritonavir n=87, 75%), more of those treated with nirmatrelvir/ritonavir had received four vaccine doses (n=27, 23%) compared with those treated with molnupiravir (n=5, 4%) (P<0.001). No differences were detected in COVID-19 severity (P=0.39) or hospitalisation (P=1.0). No statistically significant differences were identified in overall mortality rate (P=0.78) or survival probability (d30 P=0.19, d60 P=0.67, d90 P=0.68, last day of follow up P=0.68). Deaths were either attributed to COVID-19, or the infection was judged by the treating physician to have contributed to death. Conclusions: Hospitalisation and mortality rates with molnupiravir were comparable to those with nirmatrelvir/ritonavir in high-risk patients with haematological malignancies and COVID-19. Molnupiravir is a plausible alternative to nirmatrelvir/ritonavir for COVID-19 treatment in patients with haematological malignancy.
KW - Antiviral
KW - COVID-19
KW - Haematology
KW - Malignancy
KW - Molnupiravir
KW - Nirmatrelvir
KW - Ritonavir
KW - SARS-CoV-2
U2 - 10.1016/j.ijantimicag.2023.106952
DO - 10.1016/j.ijantimicag.2023.106952
M3 - Journal article
C2 - 37582478
AN - SCOPUS:85170083215
VL - 62
JO - International Journal of Antimicrobial Agents
JF - International Journal of Antimicrobial Agents
SN - 0924-8579
IS - 4
M1 - 106952
ER -
ID: 396980884