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Real-World Experience With Maribavir for Treatment of Refractory or Resistant Cytomegalovirus Infection in Hematopoietic Cell Transplant Recipients and Hematologic Malignancy Patients.
Transpl Infect Dis
January 2025
Department of Infectious Diseases, Infection Control and Employee Health, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Background: Refractory and/or resistant (R/R) cytomegalovirus (CMV) infection is a serious complication after allogeneic hematopoietic cell transplantation (HCT). Maribavir, an oral antiviral agent, was approved in November 2021 for the treatment of R/R CMV in transplant recipients. However, real-world data on the use of maribavir in HCT recipients and hematologic malignancy (HM) patients are limited.
View Article and Find Full Text PDFReal-world safety of maribavir: a retrospective study based on signal detection in the FDA adverse event reporting system.
Int J Clin Pharm
January 2025
Department of Pharmacology, The First People's Hospital of Yancheng, Yancheng, 224000, Jiangsu, China.
Background: Maribavir is a novel antiviral agent targeting cytomegalovirus through inhibition of the UL97 protein kinase, exhibiting a distinct mechanism of action. However, limited data are available on its safety profile post-marketing.
Aim: This study aimed to evaluate the adverse events (AEs) associated with maribavir using the Food and Drug Administration's Adverse Event Reporting System (FAERS), providing insights to inform clinical practice.
Maribavir for refractory cytomegalovirus infection (with or without resistance) in solid organ transplant recipients: Subgroup analysis of the phase 3 randomized SOLSTICE study.
J Heart Lung Transplant
November 2024
Division of Infectious Diseases and Geographic Medicine, University of Texas Southwestern Medical Center, Dallas, TX 75390.
Background: In the phase 3 SOLSTICE study (NCT02931539), maribavir was superior to investigator-assigned therapy (IAT) for confirmed cytomegalovirus viremia clearance at study week 8 in hematopoietic cell/solid organ transplant (HCT/SOT) recipients. We report additional efficacy and safety analyses from the SOT subgroup.
Methods: Eligible SOT recipients (n=211) received maribavir 400 mg twice daily (n=142) or IAT (n=69) for 8 weeks (12 weeks' follow-up).
[Challenges and advances in the management of HCMV infections].
Virologie (Montrouge)
October 2024
Institut toulousain des Maladies infectieuses et inflammatoires (Infinity), Université de Toulouse, Inserm, CNRS, UPS, Toulouse, France.
Human cytomegalovirus (HCMV) is one of the most important causes of complications in immunocompromised patients and congenital infections. HCMV could also represent an interesting target for treatment to limit the progression of glioblastoma, a highly aggressive tumor. Ganciclovir, foscarnet and cidofovir, which interfere with the activity of the viral polymerase pUL54, are widely used in the treatment of transplant patients.
View Article and Find Full Text PDFEvaluating Real-World Experience With Maribavir for Treatment of Refractory/Resistant Cytomegalovirus in Renal Transplant Recipients.
Clin Transplant
October 2024
Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA.
Introduction: Maribavir was recently approved by the FDA, expanding treatment options for post-solid-organ transplant refractory/resistant CMV. We sought to describe the post-marketing experience with maribavir at a large academic transplant center.
Methods: This was a retrospective observational study of all renal transplant recipients treated with maribavir for refractory/resistant CMV DNAemia/disease.
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