Post-exposure prophylaxis with sotrovimab for Omicron (B.1.1.529) SARS-CoV-2 variant during the aplastic phase of autologous stem cell transplantation

Abstract Background To date, there is no information on the safety and efficacy of the novel anti-sarbecoviruses monoclonal antibody sotrovimab administered, as a post-exposure prophylactic measure, during the aplastic phase of autologous stem cell transplantation (ASCT). Methods We describe the out...

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Main Authors: Gianpaolo Marcacci, Nicola Coppola, Emanuela Madonna, Cristina Becchimanzi, Stefania De Pascalis, Silvia D’Ovidio, Stefania Crisci, Piera Maiolino, Rosaria De Filippi, Antonio Pinto
Format: Article
Language:English
Published: BMC 2022-08-01
Series:Infectious Agents and Cancer
Subjects:
Online Access:https://doi.org/10.1186/s13027-022-00454-y
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author Gianpaolo Marcacci
Nicola Coppola
Emanuela Madonna
Cristina Becchimanzi
Stefania De Pascalis
Silvia D’Ovidio
Stefania Crisci
Piera Maiolino
Rosaria De Filippi
Antonio Pinto
author_facet Gianpaolo Marcacci
Nicola Coppola
Emanuela Madonna
Cristina Becchimanzi
Stefania De Pascalis
Silvia D’Ovidio
Stefania Crisci
Piera Maiolino
Rosaria De Filippi
Antonio Pinto
author_sort Gianpaolo Marcacci
collection DOAJ
description Abstract Background To date, there is no information on the safety and efficacy of the novel anti-sarbecoviruses monoclonal antibody sotrovimab administered, as a post-exposure prophylactic measure, during the aplastic phase of autologous stem cell transplantation (ASCT). Methods We describe the outcomes of a Multiple Myeloma (MM) patient, who was threateningly exposed to the Omicron (B.1.1.529) SARS-CoV-2 variant, two days after having received a myeloablative regimen of high-dose melphalan. The patient fulfilled all CDC criteria for prolonged close contacts with an index patient who tested positive for a molecular nasopharyngeal swab (Omicron; B.1.1.529) soon after admission to the ward. Given the high risks of morbidity and mortality in the case of COVID-19 developing during the aplastic phase of transplantation, we adopted a post-exposure prophylaxis intervention based on intravenous (i.v.) sotrovimab. Results Sotrovimab (500 mg i.v.) was administered at day + 2 from stem cells reinfusion, i.e. 4 days after myeloablative chemotherapy, and at day + 5 from the last close contact with the Omicron-positive index case. The patient was fully protected from SARS-CoV-2 infection throughout his clinical course and remained molecularly negative at the day + 30 from the transplant. We compared times to engraftment and transplant-related toxicities of the sotrovimab-treated patient with the last 15 MM patients transplanted at our Centre, evidencing no unexpected safety signals, infusion-related reactions, or alarming effects on engraftment kinetics. Conclusions We have shown here for the first time that administration of sotrovimab during the pre-engraftment phase of ASCT is effective, safe, and not associated with delays in hemopoietic recovery. As compared to MM patients who received the same myeloablative conditioning regimen, the patient given sotrovimab during the aplastic phase did not show any significant differences in engraftment kinetics and toxicity outcomes. Post-exposure prophylaxis with sotrovimab may represent a valuable approach in the stem cell transplantation setting for patients with high-risk exposure to a confirmed COVID-19 case sustained by highly infectious SARS-CoV-2 variants escaping the vaccine-derived immunity due to antigenic shifts in the spike proteins.
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spelling doaj.art-cd5de9fa28e448ed9273f321154ab6762022-12-22T02:48:43ZengBMCInfectious Agents and Cancer1750-93782022-08-011711710.1186/s13027-022-00454-yPost-exposure prophylaxis with sotrovimab for Omicron (B.1.1.529) SARS-CoV-2 variant during the aplastic phase of autologous stem cell transplantationGianpaolo Marcacci0Nicola Coppola1Emanuela Madonna2Cristina Becchimanzi3Stefania De Pascalis4Silvia D’Ovidio5Stefania Crisci6Piera Maiolino7Rosaria De Filippi8Antonio Pinto9Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione ‘G. Pascale’, IRCCSDepartment of Mental Health and Public Medicine, Section of Infectious Diseases, University of Campania Luigi VanvitelliHematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione ‘G. Pascale’, IRCCSHematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione ‘G. Pascale’, IRCCSDepartment of Mental Health and Public Medicine, Section of Infectious Diseases, University of Campania Luigi VanvitelliHematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione ‘G. Pascale’, IRCCSHematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione ‘G. Pascale’, IRCCSPharmacy Unit, Istituto Nazionale Tumori, Fondazione ‘G. Pascale’, IRCCSDepartment of Clinical Medicine and Surgery, Università Degli Studi Federico IIHematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione ‘G. Pascale’, IRCCSAbstract Background To date, there is no information on the safety and efficacy of the novel anti-sarbecoviruses monoclonal antibody sotrovimab administered, as a post-exposure prophylactic measure, during the aplastic phase of autologous stem cell transplantation (ASCT). Methods We describe the outcomes of a Multiple Myeloma (MM) patient, who was threateningly exposed to the Omicron (B.1.1.529) SARS-CoV-2 variant, two days after having received a myeloablative regimen of high-dose melphalan. The patient fulfilled all CDC criteria for prolonged close contacts with an index patient who tested positive for a molecular nasopharyngeal swab (Omicron; B.1.1.529) soon after admission to the ward. Given the high risks of morbidity and mortality in the case of COVID-19 developing during the aplastic phase of transplantation, we adopted a post-exposure prophylaxis intervention based on intravenous (i.v.) sotrovimab. Results Sotrovimab (500 mg i.v.) was administered at day + 2 from stem cells reinfusion, i.e. 4 days after myeloablative chemotherapy, and at day + 5 from the last close contact with the Omicron-positive index case. The patient was fully protected from SARS-CoV-2 infection throughout his clinical course and remained molecularly negative at the day + 30 from the transplant. We compared times to engraftment and transplant-related toxicities of the sotrovimab-treated patient with the last 15 MM patients transplanted at our Centre, evidencing no unexpected safety signals, infusion-related reactions, or alarming effects on engraftment kinetics. Conclusions We have shown here for the first time that administration of sotrovimab during the pre-engraftment phase of ASCT is effective, safe, and not associated with delays in hemopoietic recovery. As compared to MM patients who received the same myeloablative conditioning regimen, the patient given sotrovimab during the aplastic phase did not show any significant differences in engraftment kinetics and toxicity outcomes. Post-exposure prophylaxis with sotrovimab may represent a valuable approach in the stem cell transplantation setting for patients with high-risk exposure to a confirmed COVID-19 case sustained by highly infectious SARS-CoV-2 variants escaping the vaccine-derived immunity due to antigenic shifts in the spike proteins.https://doi.org/10.1186/s13027-022-00454-yMultiple myelomaAutologous stem cell transplantationSARS-CoV-2 Omicron variantSotrovimab
spellingShingle Gianpaolo Marcacci
Nicola Coppola
Emanuela Madonna
Cristina Becchimanzi
Stefania De Pascalis
Silvia D’Ovidio
Stefania Crisci
Piera Maiolino
Rosaria De Filippi
Antonio Pinto
Post-exposure prophylaxis with sotrovimab for Omicron (B.1.1.529) SARS-CoV-2 variant during the aplastic phase of autologous stem cell transplantation
Infectious Agents and Cancer
Multiple myeloma
Autologous stem cell transplantation
SARS-CoV-2 Omicron variant
Sotrovimab
title Post-exposure prophylaxis with sotrovimab for Omicron (B.1.1.529) SARS-CoV-2 variant during the aplastic phase of autologous stem cell transplantation
title_full Post-exposure prophylaxis with sotrovimab for Omicron (B.1.1.529) SARS-CoV-2 variant during the aplastic phase of autologous stem cell transplantation
title_fullStr Post-exposure prophylaxis with sotrovimab for Omicron (B.1.1.529) SARS-CoV-2 variant during the aplastic phase of autologous stem cell transplantation
title_full_unstemmed Post-exposure prophylaxis with sotrovimab for Omicron (B.1.1.529) SARS-CoV-2 variant during the aplastic phase of autologous stem cell transplantation
title_short Post-exposure prophylaxis with sotrovimab for Omicron (B.1.1.529) SARS-CoV-2 variant during the aplastic phase of autologous stem cell transplantation
title_sort post exposure prophylaxis with sotrovimab for omicron b 1 1 529 sars cov 2 variant during the aplastic phase of autologous stem cell transplantation
topic Multiple myeloma
Autologous stem cell transplantation
SARS-CoV-2 Omicron variant
Sotrovimab
url https://doi.org/10.1186/s13027-022-00454-y
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