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The interplay between Epstein-Barr Virus and Cytomegalovirus reactivation following allogeneic hematopoietic cell transplantation in the era of primary CMV prophylaxis.
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Department of Infectious Diseases, Infection Control and Employee Health, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Objectives: Epstein-Barr virus (EBV) reactivation following allogeneic hematopoietic cell transplantation (allo-HCT) is associated with increased mortality and possible post-transplant lymphoproliferative disorder (PTLD). With the lack of prophylactic agents, identifying modifiable risk factors to prevent EBV-related mortality is desired. Cytomegalovirus (CMV) DNAemia has been previously associated with EBV DNAemia; the impact of letermovir prophylaxis on this association remains unclear.
View Article and Find Full Text PDFPopulation pharmacokinetic analysis of letermovir in adult hematopoietic cell transplant recipients.
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Division of Pediatric Pharmacology and Pharmacometrics, University of Basel Children's Hospital, Basel, Switzerland.
We analyzed previously reported oral letermovir plasma concentration measurements from 40 allogeneic hematopoietic cell transplant (HCT) recipients using model-based pharmacometrics analysis. This analysis highlighted that the industry-sponsored phase III study model significantly over-predicted observed letermovir concentrations. Covariates associated with increased oral clearance (CL/F), possibly contributing to this observation, included: higher weight, younger age, and early use after HCT.
View Article and Find Full Text PDFCytomegalovirus prophylaxis with letermovir in pediatric (birth to <18 years of age) hematopoietic cell transplant recipients: pharmacokinetics, efficacy, and safety results of a Phase 2b study.
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Merck & Co., Inc., Rahway, New Jersey, USA.
Letermovir, a cytomegalovirus (CMV) terminase complex inhibitor, was first approved for prophylaxis of CMV infection and disease in adult CMV-seropositive allogeneic hematopoietic cell transplant (HCT) recipients (R+). This study evaluated the pharmacokinetics (PK), efficacy, and safety of letermovir in pediatric R+ allogeneic HCT recipients. In this Phase 2b, single-arm, open-label study, 65 participants were enrolled sequentially in three age groups (AG; AG1, 12 to <18 years; AG2, 2 to <12 years; and AG3, birth to <2 years).
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Microbiology Department, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Universitat Autònoma de Barcelona, Barcelona, Spain.
This study introduces a new procedure for antiviral resistance analysis and genetic classification of human cytomegalovirus (HCMV) using next-generation sequencing (NGS) adapted to existing methodologies, aiming for more targets due to the recent use of new antivirals. It expands the classical investigation of mutations in UL54 and UL97 genes, associated with resistance to (val)ganciclovir, foscarnet and cidofovir, to include UL27, UL56 and UL89 genes, which target newer antivirals like maribavir and letermovir. Additionally, it includes the genetic analysis of UL55 (glycoprotein B) for genotype classification.
View Article and Find Full Text PDFManagement of Cytomegalovirus Infection in Allogeneic Hematopoietic Stem Cell and in Solid Organ Transplantation: Updated Recommendations by the GITMO, SITO, SIMIT, and AMCLI Italian Societies.
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Infectious and Tropical Diseases Unit, Department of Medicine and Surgery, University of Insubria, ASST Sette Laghi, Varese, Italy.
New options for prevention and therapy of cytomegalovirus (CMV) infection and new tests for antiviral immune reconstitution are leading to increased complexity in the management of CMV after allogeneic hematopoietic stem cell (allo-HSCT) and solid organ transplantation (SOT) recipients. To inform the optimal care of these patients, under the auspices of the Italian GITMO, SITO, SIMIT, and AMCLI transplant, infectious, and clinical microbiology societies, we updated the guidelines published in 2019. New recommendations were produced using a consensus-building methodology after a comprehensive review of articles released from 2019 to 2025 (March).
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