Antivirals and monoclonal antibody combination therapy in haematological patients in the omicron era Antiviral and monoclonal Antibodies in Haematological Patients in the omicron era
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Abstract
Abstract: Im We describe here a single-center case series of 27 IC COVID-19 inpatients (mostly with haematological disorders) treated with a combined therapy based on tixagevimab/cilgavimab (T/C) plus small-molecule antivirals (AV), between April 1 2022 and November 30 2022.
Keywords: immunocompromised; SARS-CoV-2 infection; monoclonal antibodies; antivirals; persistent infection; viral evolution
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References
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6. D'Abramo A, Vita S, Maffongelli G, Mariano A, Agrati C, Castilletti C, et al. Prolonged and severe SARS-CoV-2 infection in patients under B-cell-depleting drug successfully treated: A tailored approach. Int J Infect Dis, 2021 Jun;107:247-250. doi: 10.1016/j.ijid.2021.04.068.
7. Leung WF, Chorlton S, Tyson J, Al-Rawahi GN, Jassem AN, Prystajecky N, et al. COVID-19 in an immunocompromised host: persistent shedding of viable SARS-CoV-2 and emergence of multiple mutations: a case report. Int J Infect Dis, 2022 Jan;114:178-182. doi: 10.1016/j.ijid.2021.10.045.
8. Nakajima Y, Ogai A, Furukawa K, Arai R, Anan R, Nakano Y, et al. Prolonged viral shedding of SARS-CoV-2 in an immunocompromised patient. J Infect Chemother, 2021 Feb;27(2):387-389. doi: 10.1016/j.jiac.2020.12.001.
9. DeWolf S, Laracy JC, Perales MA, Kamboj M, van den Brink MRM, Vardhana S. SARS-CoV-2 in immunocompromised individuals. Immunity, 2022 Oct 11;55(10):1779-1798. doi: 10.1016/j.immuni.2022.09.006.
10. Ko KKK, Yingtaweesittikul H, Tan TT, Wijaya L, Cao DY, Goh SS, et al. Emergence of SARS-CoV-2 Spike Mutations during Prolonged Infection in Immunocompromised Hosts. Microbiol Spectr, 2022 Jun 29;10(3):e0079122. doi: 10.1128/spectrum.00791-22.
11. D'Abramo A, Vita S, Nicastri E. Correction: The unmet need for COVID-19 treatment in immunocompromised patients. BMC Infect Dis. 2023 Jan 31;23(1):61. doi: 10.1186/s12879-023-08034-0. Erratum for: BMC Infect Dis, 2022 Dec 12;22(1):930.
12. Scaglione V, Rotundo S, Marascio N, De Marco C, Lionello R, Veneziano C, et al. Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study. BMC Infect Dis, 2022 Oct 20;22(1):793. doi: 10.1186/s12879-022-07774-9. Erratum in: BMC Infect Dis. 2022 Nov 24;22(1):883.
13. D'Abramo A, Vita S, Maffongelli G, Beccacece A, Agrati C, Cimini E, et al. Clinical Management of Patients With B-Cell Depletion Agents to Treat or Prevent Prolonged and Severe SARS-COV-2 Infection: Defining a Treatment Pathway. Front Immunol, 2022 May 27;13:911339. doi: 10.3389/fimmu.2022.911339.
14. Montgomery H, Hobbs FDR, Padilla F, Arbetter D, Templeton A, Seegobin S, et al. Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Respir Med, 2022 Oct;10(10):985-996.
15. Berno G, Fabeni L, Matusali G, Gruber CEM, Rueca M, Giombini E, Garbuglia AR. SARS-CoV-2 Variants Identification: Overview of Molecular Existing Methods. Pathogens, 2022 Sep 17;11(9):1058. doi: 10.3390/pathogens11091058. PMID: 36145490; PMCID: PMC9504725
16. Rueca M, Giombini E, Messina F, Bartolini B, Di Caro A, Capobianchi MR, et al. The Easy-to-Use SARS-CoV-2 Assembler for Genome Sequencing: Development Study. JMIR Bioinform Biotech, 2022 Mar 14;3(1):e31536. doi: 10.2196/31536.
17. Fu L, NiuB, Zhu Z, Wu S, & Li W. CD-HIT: accelerated for clustering the next-generation sequencing data. In Bioinformatics, 2012; (Vol. 28, Issue 23, pp. 3150–3152). Oxford University Press (OUP). https://doi.org/10.1093/bioinformatics/bts565
18. Nguyen LT, Schmidt HA, von Haeseler A, Minh BQ. IQ-TREE: a fast and effective stochastic algorithm for estimating maximum-likelihood phylogenies. Mol Biol Evol, 2015 Jan;32(1):268-74. doi: 10.1093/molbev/msu300. Epub 2014 Nov 3. PMID: 25371430; PMCID: PMC4271533.
19. Denkinger, C.M., Janssen, M., Schäkel, U. et al. Anti-SARS-CoV-2 antibody-containing plasma improves outcome in patients with hematologic or solid cancer and severe COVID-19: a randomized clinical trial. Nat Cancer, 4, 96–107 (2023).
20. Senefeld JW, Franchini M, Mengoli C, et al. COVID-19 Convalescent Plasma for the Treatment of Immunocompromised Patients: A Systematic Review and Meta-analysis. JAMA Netw Open, 2023;6(1):e2250647.
21. Vita S, Rosati S, Ascoli Bartoli T, Beccacece A, D'Abramo A, Mariano A, et al. Monoclonal Antibodies for Pre- and Postexposure Prophylaxis of COVID-19: Review of the Literature. Pathogens, 2022 Aug 5;11(8):882. doi: 10.3390/pathogens11080882
22. Juanola-Falgarona M, Peñarrubia L, Jiménez-Guzmán S, Porco R, Congost-Teixidor C, Varo-Velázquez M, et al. Ct values as a diagnostic tool for monitoring SARS-CoV-2 viral load using the QIAstat-Dx® Respiratory SARS-CoV-2 Panel. Int J Infect Dis, 2022 Sep;122:930-935. doi: 10.1016/j.ijid.2022.07.022.
23. Wölfel R, Corman VM, Guggemos W, Seilmaier M, Zange S, Müller MA, et al. Virological assessment of hospitalized patients with COVID-2019. Nature, 2020 May;581(7809):465-469. doi: 10.1038/s41586-020-2196-x. Epub 2020 Apr 1. Erratum in: Nature. 2020 Dec;588(7839):E35.
24. https://covdb.stanford.edu/susceptibility-data/table-mab-susc/ Accessed on June 28, 2023
25. Hammarström L, Abolhassani H, Baldanti F, Marcotte H, Pan-Hammarström Q. Development of Passive Immunity Against SARS-CoV-2 for Management of Immunodeficient Patients—a Perspective. J Allergy Clin Immunol, 2020, 146:58–60. doi: 10.1016/j.jaci.2020.04.043
26. Taylor PC, Adams AC, Hufford MM, de la Torre I, Winthrop K, Gottlieb RL. Neutralizing monoclonal antibodies for treatment of COVID-19. Nat Rev Immunol, 2021 Jun;21(6):382-393. doi: 10.1038/s41577-021-00542-x.
27. Ucciferri C, Vecchiet J, Falasca K. Role of monoclonal antibody drugs in the treatment of COVID-19. World J Clin Cases, 2020 Oct 6;8(19):4280-4285. doi: 10.12998/wjcc.v8.i19.4280.
28. De Forni D, Poddesu B, Cugia G, Chafouleas J, Lisziewicz J, Lori F. Synergistic drug combinations designed to fully suppress SARS-CoV-2 in the lung of COVID-19 patients. PLoS One, 2022 Nov 10;17(11):e0276751. doi: 10.1371/journal.pone.0276751.
29. Pagano L, Salmanton-García J, Marchesi F, Busca A, Corradini P, Hoenigl M, et al. COVID-19 infection in adult patients with hematological malignancies: a European Hematology Association Survey (EPICOVIDEHA). J Hematol Oncol, 2021 Oct 14;14(1):168. doi: 10.1186/s13045-021-01177-0. PMID: 34649563; PMCID: PMC8515781.
30. Farroni C, Aiello A, Picchianti-Diamanti A, Laganà B, Petruccioli E, Agrati C, et al.. Booster dose of SARS-CoV-2 messenger RNA vaccines strengthens the specific immune response of patients with rheumatoid arthritis: A prospective multicenter longitudinal study. Int J Infect Dis, 2022 Dec;125:195-208. doi: 10.1016/j.ijid.2022.10.035. Epub 2022 Nov 1. PMID: 36328289; PMCID: PMC962202528.
31. Focosi D, Maggi F, Franchini M, McConnell S, Casadevall A. Analysis of Immune Escape Variants from Antibody-Based Therapeutics against COVID-19: A Systematic Review. Int J Mol Sci, 2021 Dec 21;23(1):29. doi: 10.3390/ijms23010029.
32. Cox M, Peacock TP, Harvey WT, Hughes J, Wright DW; COVID-19 Genomics UK (COG-UK) Consortium et al. SARS-CoV-2 variant evasion of monoclonal antibodies based on in vitro studies. Nat Rev Microbiol, 2023 Feb;21(2):112-124. doi: 10.1038/s41579-022-00809-7.
33. https://www.fda.gov/media/156152/download , last accessed October 9, 2023
34. Andrés C, González-Sánchez A, Jiménez M, Márquez-Algaba E, Piñana M, Fernández-Naval C, et al. Emergence of Delta and Omicron variants carrying resistance-associated mutations in immunocompromised patients undergoing sotrovimab treatment with long-term viral excretion. Clin Microbiol Infect, 2022 Sep 5:S1198-743X(22)00458-X. doi: 10.1016/j.cmi.2022.08.021. Epub ahead of print. PMID: 36067943.
2. https://ecpc.org/joint-statement-on-the-protection-of-immunocompromised-patients/, accessed on Jan 20, 2023
3. Suárez-García I, Perales-Fraile I, González-García A, Muñoz-Blanco A, Manzano L, Fabregate M, et al. In-hospital mortality among immunosuppressed patients with COVID-19: Analysis from a national cohort in Spain. PLoS One, 2021 Aug 3;16(8):e0255524. doi: 10.1371/journal.pone.0255524.
4. Singson JRC, Kirley PD, Pham H, Rothrock G, Armistead I, Meek Jet al. Factors Associated with Severe Outcomes Among Immunocompromised Adults Hospitalized for COVID-19 - COVID-NET, 10 States, March 2020-February 2022. MMWR Morb Mortal Wkly Rep, 2022 Jul 8;71(27):878-884. doi: 10.15585/mmwr.mm7127a3.
5. Choi B, Choudhary MC, Regan J, Sparks JA, Padera RF, Qiu X, et al. Persistence and Evolution of SARS-CoV-2 in an Immunocompromised Host. N Engl J Med, 2020 Dec 3;383(23):2291-2293. doi: 10.1056/NEJMc2031364.
6. D'Abramo A, Vita S, Maffongelli G, Mariano A, Agrati C, Castilletti C, et al. Prolonged and severe SARS-CoV-2 infection in patients under B-cell-depleting drug successfully treated: A tailored approach. Int J Infect Dis, 2021 Jun;107:247-250. doi: 10.1016/j.ijid.2021.04.068.
7. Leung WF, Chorlton S, Tyson J, Al-Rawahi GN, Jassem AN, Prystajecky N, et al. COVID-19 in an immunocompromised host: persistent shedding of viable SARS-CoV-2 and emergence of multiple mutations: a case report. Int J Infect Dis, 2022 Jan;114:178-182. doi: 10.1016/j.ijid.2021.10.045.
8. Nakajima Y, Ogai A, Furukawa K, Arai R, Anan R, Nakano Y, et al. Prolonged viral shedding of SARS-CoV-2 in an immunocompromised patient. J Infect Chemother, 2021 Feb;27(2):387-389. doi: 10.1016/j.jiac.2020.12.001.
9. DeWolf S, Laracy JC, Perales MA, Kamboj M, van den Brink MRM, Vardhana S. SARS-CoV-2 in immunocompromised individuals. Immunity, 2022 Oct 11;55(10):1779-1798. doi: 10.1016/j.immuni.2022.09.006.
10. Ko KKK, Yingtaweesittikul H, Tan TT, Wijaya L, Cao DY, Goh SS, et al. Emergence of SARS-CoV-2 Spike Mutations during Prolonged Infection in Immunocompromised Hosts. Microbiol Spectr, 2022 Jun 29;10(3):e0079122. doi: 10.1128/spectrum.00791-22.
11. D'Abramo A, Vita S, Nicastri E. Correction: The unmet need for COVID-19 treatment in immunocompromised patients. BMC Infect Dis. 2023 Jan 31;23(1):61. doi: 10.1186/s12879-023-08034-0. Erratum for: BMC Infect Dis, 2022 Dec 12;22(1):930.
12. Scaglione V, Rotundo S, Marascio N, De Marco C, Lionello R, Veneziano C, et al. Lessons learned and implications of early therapies for coronavirus disease in a territorial service centre in the Calabria region: a retrospective study. BMC Infect Dis, 2022 Oct 20;22(1):793. doi: 10.1186/s12879-022-07774-9. Erratum in: BMC Infect Dis. 2022 Nov 24;22(1):883.
13. D'Abramo A, Vita S, Maffongelli G, Beccacece A, Agrati C, Cimini E, et al. Clinical Management of Patients With B-Cell Depletion Agents to Treat or Prevent Prolonged and Severe SARS-COV-2 Infection: Defining a Treatment Pathway. Front Immunol, 2022 May 27;13:911339. doi: 10.3389/fimmu.2022.911339.
14. Montgomery H, Hobbs FDR, Padilla F, Arbetter D, Templeton A, Seegobin S, et al. Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Respir Med, 2022 Oct;10(10):985-996.
15. Berno G, Fabeni L, Matusali G, Gruber CEM, Rueca M, Giombini E, Garbuglia AR. SARS-CoV-2 Variants Identification: Overview of Molecular Existing Methods. Pathogens, 2022 Sep 17;11(9):1058. doi: 10.3390/pathogens11091058. PMID: 36145490; PMCID: PMC9504725
16. Rueca M, Giombini E, Messina F, Bartolini B, Di Caro A, Capobianchi MR, et al. The Easy-to-Use SARS-CoV-2 Assembler for Genome Sequencing: Development Study. JMIR Bioinform Biotech, 2022 Mar 14;3(1):e31536. doi: 10.2196/31536.
17. Fu L, NiuB, Zhu Z, Wu S, & Li W. CD-HIT: accelerated for clustering the next-generation sequencing data. In Bioinformatics, 2012; (Vol. 28, Issue 23, pp. 3150–3152). Oxford University Press (OUP). https://doi.org/10.1093/bioinformatics/bts565
18. Nguyen LT, Schmidt HA, von Haeseler A, Minh BQ. IQ-TREE: a fast and effective stochastic algorithm for estimating maximum-likelihood phylogenies. Mol Biol Evol, 2015 Jan;32(1):268-74. doi: 10.1093/molbev/msu300. Epub 2014 Nov 3. PMID: 25371430; PMCID: PMC4271533.
19. Denkinger, C.M., Janssen, M., Schäkel, U. et al. Anti-SARS-CoV-2 antibody-containing plasma improves outcome in patients with hematologic or solid cancer and severe COVID-19: a randomized clinical trial. Nat Cancer, 4, 96–107 (2023).
20. Senefeld JW, Franchini M, Mengoli C, et al. COVID-19 Convalescent Plasma for the Treatment of Immunocompromised Patients: A Systematic Review and Meta-analysis. JAMA Netw Open, 2023;6(1):e2250647.
21. Vita S, Rosati S, Ascoli Bartoli T, Beccacece A, D'Abramo A, Mariano A, et al. Monoclonal Antibodies for Pre- and Postexposure Prophylaxis of COVID-19: Review of the Literature. Pathogens, 2022 Aug 5;11(8):882. doi: 10.3390/pathogens11080882
22. Juanola-Falgarona M, Peñarrubia L, Jiménez-Guzmán S, Porco R, Congost-Teixidor C, Varo-Velázquez M, et al. Ct values as a diagnostic tool for monitoring SARS-CoV-2 viral load using the QIAstat-Dx® Respiratory SARS-CoV-2 Panel. Int J Infect Dis, 2022 Sep;122:930-935. doi: 10.1016/j.ijid.2022.07.022.
23. Wölfel R, Corman VM, Guggemos W, Seilmaier M, Zange S, Müller MA, et al. Virological assessment of hospitalized patients with COVID-2019. Nature, 2020 May;581(7809):465-469. doi: 10.1038/s41586-020-2196-x. Epub 2020 Apr 1. Erratum in: Nature. 2020 Dec;588(7839):E35.
24. https://covdb.stanford.edu/susceptibility-data/table-mab-susc/ Accessed on June 28, 2023
25. Hammarström L, Abolhassani H, Baldanti F, Marcotte H, Pan-Hammarström Q. Development of Passive Immunity Against SARS-CoV-2 for Management of Immunodeficient Patients—a Perspective. J Allergy Clin Immunol, 2020, 146:58–60. doi: 10.1016/j.jaci.2020.04.043
26. Taylor PC, Adams AC, Hufford MM, de la Torre I, Winthrop K, Gottlieb RL. Neutralizing monoclonal antibodies for treatment of COVID-19. Nat Rev Immunol, 2021 Jun;21(6):382-393. doi: 10.1038/s41577-021-00542-x.
27. Ucciferri C, Vecchiet J, Falasca K. Role of monoclonal antibody drugs in the treatment of COVID-19. World J Clin Cases, 2020 Oct 6;8(19):4280-4285. doi: 10.12998/wjcc.v8.i19.4280.
28. De Forni D, Poddesu B, Cugia G, Chafouleas J, Lisziewicz J, Lori F. Synergistic drug combinations designed to fully suppress SARS-CoV-2 in the lung of COVID-19 patients. PLoS One, 2022 Nov 10;17(11):e0276751. doi: 10.1371/journal.pone.0276751.
29. Pagano L, Salmanton-García J, Marchesi F, Busca A, Corradini P, Hoenigl M, et al. COVID-19 infection in adult patients with hematological malignancies: a European Hematology Association Survey (EPICOVIDEHA). J Hematol Oncol, 2021 Oct 14;14(1):168. doi: 10.1186/s13045-021-01177-0. PMID: 34649563; PMCID: PMC8515781.
30. Farroni C, Aiello A, Picchianti-Diamanti A, Laganà B, Petruccioli E, Agrati C, et al.. Booster dose of SARS-CoV-2 messenger RNA vaccines strengthens the specific immune response of patients with rheumatoid arthritis: A prospective multicenter longitudinal study. Int J Infect Dis, 2022 Dec;125:195-208. doi: 10.1016/j.ijid.2022.10.035. Epub 2022 Nov 1. PMID: 36328289; PMCID: PMC962202528.
31. Focosi D, Maggi F, Franchini M, McConnell S, Casadevall A. Analysis of Immune Escape Variants from Antibody-Based Therapeutics against COVID-19: A Systematic Review. Int J Mol Sci, 2021 Dec 21;23(1):29. doi: 10.3390/ijms23010029.
32. Cox M, Peacock TP, Harvey WT, Hughes J, Wright DW; COVID-19 Genomics UK (COG-UK) Consortium et al. SARS-CoV-2 variant evasion of monoclonal antibodies based on in vitro studies. Nat Rev Microbiol, 2023 Feb;21(2):112-124. doi: 10.1038/s41579-022-00809-7.
33. https://www.fda.gov/media/156152/download , last accessed October 9, 2023
34. Andrés C, González-Sánchez A, Jiménez M, Márquez-Algaba E, Piñana M, Fernández-Naval C, et al. Emergence of Delta and Omicron variants carrying resistance-associated mutations in immunocompromised patients undergoing sotrovimab treatment with long-term viral excretion. Clin Microbiol Infect, 2022 Sep 5:S1198-743X(22)00458-X. doi: 10.1016/j.cmi.2022.08.021. Epub ahead of print. PMID: 36067943.
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Apr 30, 2024
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Vita, S. (2024) “Antivirals and monoclonal antibody combination therapy in haematological patients in the omicron era: Antiviral and monoclonal Antibodies in Haematological Patients in the omicron era”, Mediterranean Journal of Hematology and Infectious Diseases, 16(1), p. e2024043. doi: 10.4084/MJHID.2024.043.
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