Marcacci Gianpaolo, Coppola Nicola, Madonna Emanuela, Becchimanzi Cristina, De Pascalis Stefania, D'Ovidio Silvia, Crisci Stefania, Maiolino Piera, De Filippi Rosaria, Pinto Antonio
Hematology-Oncology and Stem Cell Transplantation Unit, Istituto Nazionale Tumori, Fondazione 'G. Pascale', IRCCS, Via Mariano Semmola 49, 80131, Naples, Italy.
Department of Mental Health and Public Medicine, Section of Infectious Diseases, University of Campania Luigi Vanvitelli, Naples, Italy.
Infect Agent Cancer. 2022 Aug 3;17(1):41. doi: 10.1186/s13027-022-00454-y.
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).
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.
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.
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.
迄今为止，尚无关于新型抗沙贝病毒单克隆抗体索托维单抗在自体干细胞移植（ASCT）再生障碍期作为暴露后预防措施使用时的安全性和有效性的信息。
我们描述了一名多发性骨髓瘤（MM）患者的情况，该患者在接受大剂量美法仑清髓方案两天后，受到奥密克戎（B.1.1.529）SARS-CoV-2变体的威胁性暴露。该患者符合疾病控制与预防中心（CDC）关于与一名入院后不久鼻咽拭子分子检测呈阳性（奥密克戎；B.1.1.529）的索引患者长期密切接触的所有标准。鉴于在移植再生障碍期发生COVID-19时发病和死亡风险较高，我们采取了基于静脉注射索托维单抗的暴露后预防干预措施。
索托维单抗（静脉注射500mg）在干细胞回输后第2天给药，即清髓化疗后4天，以及与奥密克戎阳性索引病例最后一次密切接触后第5天给药。该患者在整个临床过程中完全受到保护，未感染SARS-CoV-2，在移植后第30天分子检测仍为阴性。我们将接受索托维单抗治疗的患者的植入时间和移植相关毒性与本中心此前移植的15例MM患者进行了比较，未发现意外的安全信号、输液相关反应或对植入动力学的不良影响。
我们首次证明，在ASCT植入前阶段使用索托维单抗是有效、安全的，且与造血恢复延迟无关。与接受相同清髓预处理方案的MM患者相比，在再生障碍期接受索托维单抗治疗的患者在植入动力学和毒性结果方面没有显著差异。对于因刺突蛋白抗原性变化而逃避疫苗诱导免疫的高传染性SARS-CoV-2变体导致的确诊COVID-19病例高风险暴露患者，索托维单抗暴露后预防可能是干细胞移植环境中的一种有价值的方法。
