Letermovir Prophylaxis for Cytomegalovirus Infection in Children After Hematopoietic Cell Transplantation

Richert-Przygońska, Monika; Jaremek, Kamila; Dębski, Robert; Konieczek, Joanna; Łęcka, Monika; Dziedzic, Magdalena; Bogiel, Tomasz; Styczyński, Jan; Czyżewski, K

doi:10.21873/anticanres.15848

Cited by 23 publications

(23 citation statements)

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“…This confirms that our control group was representative and comparable and emphasizes the high efficacy of letermovir as CMV prophylaxis with much lower rates of CMV reactivation. Recently, letermovir has also been shown to be safe to use in children and effective in preventing CMV reactivation and associated complications (18). Mori et al, in their multicenter retrospective analysis, have seen similar rates of CMV reactivations compared to our retrospective analysis.…”

Section: Discussionsupporting

confidence: 68%

Letermovir Prophylaxis for CMV Reactivation in Allogeneic Stem Cell Recipients: A Retrospective Single Center Analysis

et al. 2022

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Background/Aim: Cytomegalovirus (CMV) reactivation is one of the most clinically significant complications in allogeneic stem cell recipients and a frequent cause for transplantation related mortality. Letermovir is a newly available and recently approved drug for CMV prophylaxis. In a retrospective single center analysis, we investigated the benefit of letermovir as CMV prophylaxis in allogeneic stem cell recipients. Patients and Methods: We included 48 CMV-seropositive transplant recipients from January 2017 to August 2020 from our department. We compared the rate of CMV reactivation in patients who received letermovir as prophylaxis from day 0 after allogeneic stem cell transplantation (alloSCT) with a control group that did not receive CMV prophylaxis. The primary endpoint was CMV reactivation and was defined as an increase of CMV copies over 1250 Ul/ml in the peripheral blood; secondary endpoints were overall survival (OS) up to 180 days, engraftment and all-cause mortality. Results: We included 21 patients in the control group and 27 patients in the letermovir group. Letermovir treatment led to a significantly reduced incidence of CMV reactivation after alloSCT (33.3% in the letermovir group versus 76.2% in the control group, p<0.001). The OS at day 180 was 80.9% in the control group versus 92.6% in the letermovir group (p<0.05). The median duration of letermovir prophylaxis was 192±104 days. Conclusion: Our results indicate that letermovir prophylaxis is associated with a significant lower risk of CMV reactivation and improved overall survival in CMV-seropositive stem cell recipients. Moreover, a prolonged use of letermovir prophylaxis might be a survival benefit.

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Section: Discussionsupporting

confidence: 68%

Letermovir Prophylaxis for CMV Reactivation in Allogeneic Stem Cell Recipients: A Retrospective Single Center Analysis

et al. 2022

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“…We found nine reports that fulfilled the search criteria, published between 2019 and 2022 (Table I) [1,[4][5][6][7][8][10][11][12]. The total number of cases involved in research was 46, with the patients' ages ranging from 2 to 19 years.…”

Section: Resultsmentioning

confidence: 99%

“…The most common clinical manifestations of CMVi in HSCT patients include pneumonia, hepatitis, enteritis, retinitis and bone marrow suppression. Moreover, CMVi increases the risk of life-threatening secondary bacterial and fungal infections as well as graft-versus-host disease (GvHD) development and graft failure [2,6,7]. Documented high risk factors of CMVi include: CMV-seronegative donor/recipient, CMV positive serostatus (D-/R+) [odds ratio (OR) = 11.0], grade 3-4 of acute GvHD (aGVDH) (OR = 5.4), and unrelated (OR = 6.0) and mismatched donors (OR = 4.2) [8,9].…”

Section: Introductionmentioning

confidence: 99%

“…Studies on LMV used as primary prophylaxis proved its high efficacy at reducing the incidence of CMV disease and the number of deaths caused by CMVi [2][3][4][5][6][7]11]. In 2017, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved LMV for primary prophylaxis in CMV-seropositive adult patients undergoing allogeneic HSCT (allo-HSCT) [2-8, 10, 11].…”

Section: Introductionmentioning

confidence: 99%

“…However, it was not registered for CMVi preemptive treatment, CMVi secondary prophylaxis, or the treatment of CMV disease [2,3,7]. There is very limited data regarding LMV's use in pediatric patients as it has not been approved so far as any kind of treatment in children, with its use remaining off label [1][2][3][4][5][6][7][8][10][11][12]. The aim of this study was to summarize reported data on the efficacy and safety of LMV in pediatric patients.…”

Section: Introductionmentioning

confidence: 99%

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Letermovir use in children after hematopoietic cell transplantation: summary of reported data

Styczyński

Sadlok²,

Richert-Przygońska³

et al. 2023

Acta Haematol Pol.

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Immunovirology of cytomegalovirus infection in allogeneic stem cell transplant recipients undergoing prophylaxis with letermovir: A narrative review

Solano

Giménez

Albert

et al. 2023

Journal of Medical Virology

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On November 7, 2017, the US Food and Drug Administration approved the use of letermovir (LMV) for prophylaxis of cytomegalovirus (CMV) infection in adult CMV‐seropositive allogeneic stem cell transplant recipients. After 6 years of use, a large body of real‐world experience has been accumulated that validates the Phase III clinical trial results, in which LMV was shown to significantly reduce the risk of clinically significant CMV infection—defined as CMV end‐organ disease or CMV DNAemia requiring pre‐emptive antiviral therapy (PET)—and increase survival up to Week 24 after treatment inception. Notwithstanding, several issues still need to be settled, thus further investigation is required. First, since viral DNA may accumulate as a result of LMV‐driven abortive CMV infection, what is the optimal viral load threshold in the blood that would prompt LMV prophylaxis interruption and PET inception? Should this be adapted to the patient's risk? Second, what is the impact of LMV prophylaxis on the reconstitution of functional CMV‐specific T‐cell responses? Would it be a wise approach to individually tailor the duration of LMV treatment according to the number of peripheral blood CMV‐specific T cells at the end of regular prophylaxis? Third, how frequently do LMV‐resistant strains arise while patients are on LMV prophylaxis and how could this be minimized? Here, we discuss the literature addressing these topics.

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Letermovir Prophylaxis for Cytomegalovirus Infection in Children After Hematopoietic Cell Transplantation

Cited by 23 publications

References 0 publications

Letermovir Prophylaxis for CMV Reactivation in Allogeneic Stem Cell Recipients: A Retrospective Single Center Analysis

Letermovir Prophylaxis for CMV Reactivation in Allogeneic Stem Cell Recipients: A Retrospective Single Center Analysis

Letermovir use in children after hematopoietic cell transplantation: summary of reported data

Immunovirology of cytomegalovirus infection in allogeneic stem cell transplant recipients undergoing prophylaxis with letermovir: A narrative review

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