Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Jul 1;11(7):ofae353.
doi: 10.1093/ofid/ofae353. eCollection 2024 Jul.

Multicenter Analysis of Valganciclovir Prophylaxis in Pediatric Solid Organ Transplant Recipients

Marc Foca  1 , Salih Demirhan  1 , Flor M Munoz  2 , Kristen G Valencia Deray  2 , Claire E Bocchini  2 , Tanvi S Sharma  3 , Gilad Sherman  3 , William J Muller  4 , Taylor Heald-Sargent  4 , Lara Danziger-Isakov  5 , Samantha Blum  5 , Juri Boguniewicz  6 , Samantha Bacon  6 , Tuhina Joseph  3 , Jodi Smith  7 , Monica I Ardura  8 , Yin Su  9 , Gabriela M Maron  9 , Jose Ferrolino  9 , Betsy C Herold  1
Affiliations

Multicenter Analysis of Valganciclovir Prophylaxis in Pediatric Solid Organ Transplant Recipients

Marc Foca et al. Open Forum Infect Dis. .

Abstract

Background: Valganciclovir is the only approved antiviral for cytomegalovirus (CMV) prevention in pediatric solid organ transplantation (SOT). Additional approaches may be needed to improve outcomes.

Methods: A multicenter retrospective study from 2016 to 2019 was conducted of pediatric SOT recipients in whom at least 3 months of valganciclovir prophylaxis was planned. Episodes of CMV DNA in blood (DNAemia), CMV disease, drug-related toxicities, as well as other infections in the first year posttransplant and demographic and clinical data were collected. CMV DNAemia in the first year after prophylaxis or during prophylaxis (breakthrough) was analyzed by multivariate hazard models.

Results: Among the 749 patients enrolled, 131 (17.5%) had CMV DNAemia at any time in the first year; 85 (11.4%) had breakthrough DNAemia, and 46 (6.1%) had DNAemia after prophylaxis. CMV disease occurred in 30 (4%). In a multivariate model, liver transplantation compared to kidney or heart, intermediate or high risk based on donor/recipient serologies, neutropenia, and valganciclovir dose modifications attributed to toxicity were associated with increased risk of total and/or breakthrough DNAemia. Bacteremia was also associated with increased hazard ratio for CMV DNAemia. In a separate multivariate analysis, rejection occurred more often in those with breakthrough CMV DNAemia (P = .002); liver transplants, specifically, had increased rejection if CMV DNAemia occurred in the first year (P = .004). These associations may be bidirectional as rejection may contribute to infection risk.

Conclusions: CMV DNAemia in the first year posttransplantation occurs despite valganciclovir prophylaxis and is associated with medication toxicity, bacteremia, and rejection. Pediatric studies of newer antivirals, especially in higher-risk subpopulations, appear to be warranted.

Keywords: Cytomegalovirus (CMV); Pediatrics; Solid Organ Transplantion.

PubMed Disclaimer

Conflict of interest statement

Potential conflicts of interest. All authors: No reported conflicts.

Figures

Figure 1.
Figure 1.
Cox regression model for breakthrough cytomegalovirus DNAemia. Abbreviations: CI, confidence interval; CMV, cytomegalovirus; EBV, Epstein-Barr virus; IVIG, intravenous immunoglobulin; TMP-SMX, trimethoprim-sulfamethoxazole; VGCV, valganciclovir.
See this image and copyright information in PMC

References

    1. Pescovitz MD, Pruett TL, Gonwa T, et al. Oral ganciclovir dosing in transplant recipients and dialysis patients based on renal function. Transplantation 1998; 66:1104–7. - PubMed
    1. Huntjens DW, Dijkstra JA, Verwiel LN, et al. Optimizing antiviral dosing for HSV and CMV treatment in immunocompromised patients. Pharmaceutics 2023; 15:163. - PMC - PubMed
    1. Paya C, Humar A, Dominguez E, et al. Efficacy and safety of valganciclovir vs. oral ganciclovir for prevention of cytomegalovirus disease in solid organ transplant recipients. Am J Transplant 2004; 4:611–20. - PubMed
    1. Lapidus-Krol E, Shapiro R, Amir J, et al. The efficacy and safety of valganciclovir vs. oral ganciclovir in the prevention of symptomatic CMV infection in children after solid organ transplantation. Pediatr Transplant 2010; 14:753–60. - PubMed
    1. Pescovitz MD, Ettenger RB, Strife CF, et al. Pharmacokinetics of oral valganciclovir solution and intravenous ganciclovir in pediatric renal and liver transplant recipients. Transpl Infect Dis 2010; 12:195–203. - PubMed

LinkOut - more resources