Hybrid Ganciclovir/Valacyclovir Prophylaxis Reduces CMV Reactivation in High-Risk Allogeneic Stem Cell Transplant Recipients

Maryam  Barkhordar; Amirabbas  Rashidi; Mohammad  Vaezi; Neda  Alijani; Seied Asadollah  Mousavi; Sahar Tavakoli  Shiraji; Mojtaba Azari  Alanjeq; Mehrdad  Abbaszadeh; Hosein Kamranzadeh  Fumani; Tanaz  Bahri

doi:10.18502/ijhoscr.v19i4.19979

Maryam Barkhordar Hematologic Malignancies Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran
Amirabbas Rashidi Hematologic Malignancies Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran
Mohammad Vaezi Hematologic Malignancies Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran
Neda Alijani Department of Infectious Diseases, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
Seied Asadollah Mousavi Hematologic Malignancies Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran
Sahar Tavakoli Shiraji Department of Infectious Diseases, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
Mojtaba Azari Alanjeq Independent Researcher, Tehran, Iran
Mehrdad Abbaszadeh Hematologic Malignancies Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran
Hosein Kamranzadeh Fumani Hematologic Malignancies Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran
Tanaz Bahri Hematologic Malignancies Research Center, Research Institute for Oncology, Hematology and Cell Therapy, Tehran University of Medical Sciences, Tehran, Iran

DOI: https://doi.org/10.18502/ijhoscr.v19i4.19979

Keywords: Cytomegalovirus prophylaxis; Allogeneic stem cell transplantation; Ganciclovir; Valacyclovir; Hybrid regimen; Preemptive therapy; CMV reactivation; Haploidentical transplant

Abstract

Background: Cytomegalovirus (CMV) reactivation remains a critical concern following allogeneic hematopoietic stem cell transplantation (allo-HSCT), particularly in CMV-seropositive patients undergoing allo-HSCT from alternative donors. This study explored whether a hybrid CMV prophylaxis regimen would be more effective than the standard preemptive regimen in resource-limited settings where Letermovir is unavailable or cost-prohibitive.

Materials and Methods: This prospective single-center cohort study included adult patients with acute leukemia who received allo-HSCT from alternative donors between November 2018 and May 2022. The primary outcome was the evaluation of the CMV reactivation incidence in allo-HSCT patients receiving the hybrid CMV prophylaxis regimen comprising pretransplant ganciclovir followed by high-dose valacyclovir compared with the control patients who received the preemptive regimen. Secondary outcomes included overall survival (OS), disease-free survival (DFS), GVHD-free relapse-free survival (GRFS), and non-relapse mortality (NRM) between the two groups.

Results: A total of 80 patients, 34 receiving hybrid CMV prophylaxis and 46 received the preemptive protocol. The hybrid prophylaxis group exhibited a significantly lower incidence of CMV reactivation at 90 days post-transplantation (34% vs. 82%, P = 0.000). However, no statistically significant differences were observed in the overall survival, disease-free survival, or non-relapse mortality.

Conclusion: The hybrid regimen reduced CMV reactivation in high-risk HSCT recipients but did not improve survival outcomes, offering a practical alternative in settings with limited access to Letermovir.