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Comparison of Two Dosing Regimens of Valganciclovir for Cytomegalovirus Prophylaxis in High-Risk Liver Transplant Recipients

A. L. Bixby, L. Fitzgerald, L. Cotiguala, J. M. Park, D. Kaul, C. Sonnenday, S. Tischer

Michigan Medicine, Ann Arbor, MI

Meeting: 2019 American Transplant Congress

Abstract number: A322

Keywords: Cytomeglovirus, Liver transplantation, Neutropenia, Viral therapy

Session Information

Session Name: Poster Session A: Transplant Infectious Diseases

Session Type: Poster Session

Date: Saturday, June 1, 2019

Session Time: 5:30pm-7:30pm

 Presentation Time: 5:30pm-7:30pm

Location: Hall C & D

*Purpose: Significant controversy surrounds the optimal dose and duration of valganciclovir (VGCV) to prevent CMV in high-risk (D+/R-) liver transplant (LT) recipients. High doses cause leukopenia leading to premature discontinuation. Underdosing raises concerns for breakthrough CMV infection and ganciclovir resistance. The purpose of this study was to compare the safety and efficacy of two VGCV regimens for CMV prophylaxis in high-risk LT recipients.

*Methods: This study was a single-center retrospective review of CMV high-risk adult LT recipients who were prophylaxed with VGCV 450 mg/day for 90 days and transplanted between January 2010 to December 2013 (Group 1) vs those who were prophylaxed with VGCV 900 mg/day for 180 days and transplanted between August 2014 to July 2017 (Group 2). Patients were excluded if death <30 days of transplant or multi-organ transplant recipients. The primary outcome was incidence of CMV disease (CMV viremia with attributable symptoms) at 1 year. Secondary outcomes included rates of CMV syndrome, end-organ disease, breakthrough infection, and resistance. Neutropenia, early discontinuation of VGCV, growth colony stimulating factors use, biopsy-proven rejection, graft loss, and death at 1 year were analyzed.

*Results: 101 patients were screened for inclusion: 4 excluded for multi-organ transplant, 1 for death within 30 days of transplant. There was no difference in baseline characteristics (Table 1). Although no difference in rates of CMV disease, Group 1 had a higher incidence of CMV end-organ disease with 2 cases of GCV resistance. Significantly more patients in Group 2 developed neutropenia during prophylaxis with VGCV. Consequently, 37% of Group 2 required early discontinuation of VGCV. Of patients that had an interruption in VGCV prophylaxis, 31% developed CMV (33% vs 31%; p=1). Group 1 and 2 had similar rates of BPAR (16% vs 14%), graft loss (5% vs 3%), and death (3% vs 3%) at 1 year.

*Conclusions: Although VGCV 900 mg/day for 180 days was poorly tolerated with higher rates of hematologic adverse effects, it may be preferred due to less CMV end-organ disease. Further evaluation into cytopenia management is warranted to ensure optimization of CMV prophylaxis.

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To cite this abstract in AMA style:

Bixby AL, Fitzgerald L, Cotiguala L, Park JM, Kaul D, Sonnenday C, Tischer S. Comparison of Two Dosing Regimens of Valganciclovir for Cytomegalovirus Prophylaxis in High-Risk Liver Transplant Recipients [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/comparison-of-two-dosing-regimens-of-valganciclovir-for-cytomegalovirus-prophylaxis-in-high-risk-liver-transplant-recipients/. Accessed June 27, 2025.

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