CMV Management With Specific Immunoglobulins: A Multicentric Retrospective Analysis on 92 Allotransplanted Patients.

Abstract

CMV represents one of the most serious life-threatening complications of allogeneic stem cell transplantaion (allo-SCT). Pre-emptive treatment is highly effective, but toxicity and repetitive reactivation of CMV represent a major challenge in the clinical practice. The use of anti-CMV specific immunoglobulins (Megalotect) is controversial.
 We retrospectively collected data on 92 patients submitted to allo-SCT for hematological malignancies, in whom Megalotect was used either for prophylaxis (n=14) or with pre-emptive therapy (n=78). All the patients were considered at high-risk of developing CMV reactivation and CMV disease.
 The treatment was well tolerated, with no reported infusion reactions, nor other adverse events. None of the 14 cases treated with Megalotect as prophylaxis developed CMV reactivation. 51/78 (65%) patients who received Megalotect during pre-emptive treatment achieved complete clearance of CMV viremia, and 14/51 patients (29%) developed a breakthroug CMV infection. 7/78 patients (9%) developed CMV disease. The projected 1-year OS, 1-year TRM and 1-year RR is 74%, 15% and 19%, respectively. No differences were observed in terms of OS, TRM and RR by comparing patients who achieved a complete response after treatment versus those who did not..
 These retrospective data suggest that Megalotect is safe and well tolerated. When used as prophylaxis, no CMV reactivation was recorded. We have no conclusive data regarding its efficacy in reducing the cumulative dose of anti-CMV specific drugs in the pre-emptive setting. Further prospective trials are warrented to identify the best setting of patients who can benefit from Megalotect alone or in addition to anti-CMV specific drugs.

Advances in CMV Management: A Single Center Real-Life Experience

“…PET is generally continued for at least 2 weeks, and stopped after at least one (Ljungman et al, 2019) or preferably two consecutive negative tests (Girmenia et al, 2019). Although anti-CMV hyper-immunoglobulins (Megalotect) can be safely used (Malagola et al, 2019), no conclusive data are available to recommend a routine use, and both the ECIL-7 guidelines and the Italian guidelines do not recommend the routine use of anti-CMV hyper-immunoglobulins (Girmenia et al, 2019;Ljungman et al, 2019).…”

Cytomegalovirus reactivation after hematopoietic stem cell transplant with CMV‐IG prophylaxis: A monocentric retrospective analysis

“…A recent study retrospectively analyzed 92 patients from six Italian BMT units, transplanted between 2016 and 2017, for whom CMV‐IG (Megalotect Biotest®) was used either as prophylaxis (14 patients, 15%) or as adjunctive pre‐emptive support (78 patients, 85%). None of the patients under prophylaxis developed CMV reactivation whereas in pre‐emptive context 9% developed CMV disease, while neither differences in OS, nor in TRM nor in RR were observed 30 . Nonetheless, the number of patients considered in the prophylactic approach was too small to draw firm conclusions about its apparently beneficial effect.…”

CMV retinitis in a stem cell transplant recipient treated with foscarnet intravitreal injection and CMV specific immunoglobulins

“…Studies evaluating the efficacy of IVIG in HSCT recipients with CMV infection are lacking. [20][21][22] Since foscarnet is virostatic, 23 we can Table 1. Summary of published cases of adult patients with CMVR following allogeneic HSCT treated with local antiviral therapy.…”

“…Studies evaluating the efficacy of IVIG in HSCT recipients with CMV infection are lacking. 20 – 22 Since foscarnet is virostatic, 23 we can speculate that IVIG might have contributed to control viral replication once systemic treatment with foscarnet has been discontinued.…”