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Efficacy and Safety of Delayed, Low-Dose Valganciclovir in High-Risk Cytomegalovirus Liver Transplant Recipients

S. Anders1, A. Freeman1, L. Hutchinson1, U. Kaszubski1, M. Janusek1, A. Hooter2, D. Raymond2, C. Nguyen2

1Ochsner Medical Center, New Orleans, LA, 2Xavier University, New Orleans, LA

Meeting: 2022 American Transplant Congress

Abstract number: 1664

Keywords: Cytomeglovirus, Economics, Liver transplantation, Outcome

Topic: Clinical Science » Pharmacy » 30 - Non-Organ Specific: Clinical Pharmacy/Transplant Pharmacotherapy

Session Information

Session Name: Pharmacy II

Session Type: Poster Abstract

Date: Tuesday, June 7, 2022

Session Time: 7:00pm-8:00pm

 Presentation Time: 7:00pm-8:00pm

Location: Hynes Halls C & D

*Purpose: The goal of this study was to compare the safety and efficacy of a delayed valganciclovir (VGCV) dosing protocol for cytomegalovirus (CMV) prophylaxis in liver transplant (LT) recipients who are high risk for CMV (D+/R-).

*Methods: This was a single-center, retrospective review of adult CMV high risk LT recipients that evaluated a 4/2019 protocol change that delayed the initiation of VGCV. All CMV high risk recipients received VGCV 450mg/day (reduced to TIW for CrCl <40) for 180 days, which was initiated on post-op day (POD) 0 in the pre-protocol group and on POD 10 or hospital discharge in the post-protocol group. The primary outcome was CMV disease at 1 year. Secondary outcomes included tissue-invasive disease, breakthrough CMV infection, and detection of CMV resistant genotypes. Safety outcomes included neutropenia (defined as an absolute neutrophil count < 750), growth colony stimulating factors use (G-CSF), biopsy-proven rejection (BPAR), graft loss, and death at 1 year.

*Results: One hundred CMV D+/R- LT recipients were included. No statistical difference was found in the incidence of CMV disease at 1 year (p=0.5465), tissue invasive disease (p=1) or breakthrough CMV infections (p=0.1475). Only 1 patient in the post-protocol group developed resistance. With regard to safety outcomes, there was no difference in GCSF use or BPAR, however there was significantly more death and graft loss observed at 1 year in pre-protocol group versus the post-protocol group (p=0.0117). Neutropenia was also more common in the pre-protocol group.

*Conclusions: In a study of 100 high risk CMV LT patients, low-dose, delayed VGCV appears to be a safe and effective approach to managing CMV prophylaxis. There was no difference in incidence of CMV, resistance, breakthrough infection, or tissue invasive disease at 1 year. This approach had favorable outcomes, demonstrating less neutropenia, death and graft loss at 1 year. Delaying VGCV by up to 10 days has provided a safe and effective protocol for CMV prevention for LT recipients, while also providing a cost-containment strategy for the hospital.

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To cite this abstract in AMA style:

Anders S, Freeman A, Hutchinson L, Kaszubski U, Janusek M, Hooter A, Raymond D, Nguyen C. Efficacy and Safety of Delayed, Low-Dose Valganciclovir in High-Risk Cytomegalovirus Liver Transplant Recipients [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/efficacy-and-safety-of-delayed-low-dose-valganciclovir-in-high-risk-cytomegalovirus-liver-transplant-recipients/. Accessed May 25, 2025.

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