Comparison of standard versus low‐dose valganciclovir regimens for cytomegalovirus prophylaxis in high‐risk liver transplant recipients

Bixby, Alexandra L; Fitzgerald, Linda J; Park, Jeong Mi; Kaul, Daniel R; Tischer, Sarah

doi:10.1111/tid.13713

Cited by 6 publications

(7 citation statements)

References 21 publications

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“…An additional study evaluated valganciclovir 450 mg daily versus 900 mg daily in high-risk LT patients who received triple immunosuppression. 17 The primary outcome, CMV disease, was not found to be statistically significant between the two groups, but 75% of CMV infections in the low-dose group had end-organ disease involvement. The study also found the standard-dose group had significantly more neutropenia than the lowdose group (10% vs. 60%, p < .001).…”

Section: Discussionmentioning

confidence: 80%

“…In this way, assessing the impact of this immunosuppression strategy on our CMV prophylaxis strategy was not possible. An additional study evaluated valganciclovir 450 mg daily versus 900 mg daily in high‐risk LT patients who received triple immunosuppression 17 . The primary outcome, CMV disease, was not found to be statistically significant between the two groups, but 75% of CMV infections in the low‐dose group had end‐organ disease involvement.…”

Section: Discussionmentioning

confidence: 99%

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Incidence and risk factors for the development of cytomegalovirus viremia in a steroid sparing liver transplant center

Viehl

Lichvar

Chan

et al. 2022

Transplant Infectious Dis

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Background: Cytomegalovirus (CMV) is a common opportunistic infection in patients after liver transplant (LT). Guidelines recommend 900 mg daily of valganciclovir; however, valganciclovir commonly causes dose-dependent hematologic toxicities. Use of a low-dose valganciclovir (450 mg) has been used to prevent these adverse effects, but the data regarding this dosing strategy are not as robust in a steroid sparing LT center. Methods: Retrospective chart review of adult LT recipients between January 1, 2008 and June 30, 2019. All patients received low-dose valganciclovir 450 mg PO daily for CMV prophylaxis. Primary outcome was the incidence of CMV viremia in LT recipients at 12 months post-LT. Secondary outcomes include time to CMV viremia, risk factors for the development of CMV viremia, and incidence of breakthrough CMV viremia while on valganciclovir prophylaxis.Results: A total of 266 patients were included. Overall, the majority were male (63.2%) and Caucasian (45.5%). The most common indication for transplant was decompensated cirrhosis (82%). The incidence of CMV at 1 year posttransplant was 7.9%. Independent risk factors included high risk status (OR 5.97, 95% CI 2.14-16.61, p = .001) as well as having an episode of rejection (OR 5.99, 95% CI 2.16-16.66, p = .001). Conclusion:Low-dose valganciclovir can be effective in the prevention of CMV viremia in LT patients and may be a beneficial strategy for CMV prophylaxis in a steroid-sparing transplant center. Further studies may be needed to determine appropriate length of prophylaxis therapy for different risk groups.

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Section: Discussionmentioning

confidence: 80%

Section: Discussionmentioning

confidence: 99%

Incidence and risk factors for the development of cytomegalovirus viremia in a steroid sparing liver transplant center

Viehl

Lichvar

Chan

et al. 2022

Transplant Infectious Dis

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“…Other studies concluded the low or reduced dosing regimen appeared as beneficial and safer than the full dosing regimen 18,21,22 . Neutropenia and leukopenia are two common adverse effects of valganciclovir, making appropriate endpoints to evaluate medication safety.…”

Section: Resultsmentioning

confidence: 99%

Reduced dosing versus full dosing valganciclovir for prophylaxis of cytomegalovirus in high‐risk abdominal transplant recipients

Kreiser,

Dupuis,

Szempruch

et al. 2023

Clinical Transplantation

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BackgroundCytomegalovirus (CMV) is a common infection in abdominal transplant recipients (ATR). Prevention of CMV in the highest risk population (CMV IgG donor+/recipient‐) is critical as CMV is associated with negative outcomes. Guideline recommended prophylactic valganciclovir dosing is 900 mg daily for 6 months in this population. However, reduced dosing strategies are utilized in practice.MethodsThis single center, retrospective study in adult ATR compared full valganciclovir prophylactic dosing (900 mg daily for 6 months) to reduced dosing (900 mg daily for 3 months, then 450 mg daily for 3 months). The primary endpoint was incidence of CMV infection with viral load >1000 IU/mL. Secondary endpoints included incidence of CMV infection with viral load 200–1000 IU/mL, neutropenia, and leukopenia.ResultsIncidence of CMV infection with viral load >1000 IU/mL (29% vs. 27%, p = 1) or CMV infection with viral load 200‐1000 IU/mL (6% vs. 12%, p = .421) did not differ significantly between 68 ATR in reduced and full dosing groups, as well as incidence of leukopenia (94% vs. 97%, p = 1) and neutropenia (77% vs. 70%, p = .586).ConclusionsThere was no difference in the incidence of CMV infection, neutropenia, or leukopenia of the two dosing regimens, although time to CMV diagnosis was different.

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“…It was reported that 60% of patients receiving a dosage of 900 mg of valganciclovir experienced leukopenia of grade 3 or higher, and 20% of patients required administration of granulocyte colony-stimulating factor. 23 To address this challenge, we aimed to identify ganciclovir trough concentrations that predict hematological toxicity and factors that may influence ganciclovir serum concentrations in lung transplant patients receiving valganciclovir prophylaxis. Our results indicated that a trough ganciclovir concentration of 872.0 ng/mL or higher was significantly associated with the development of severe leukopenia.…”

Section: Discussionmentioning

confidence: 99%

“…Valganciclovir is the first‐line drug used for the prevention of CMV infection 4 ; however, its use is associated with a relatively high risk of hematologic toxicity, which can lead to treatment discontinuation. It was reported that 60% of patients receiving a dosage of 900 mg of valganciclovir experienced leukopenia of grade 3 or higher, and 20% of patients required administration of granulocyte colony‐stimulating factor 23 . To address this challenge, we aimed to identify ganciclovir trough concentrations that predict hematological toxicity and factors that may influence ganciclovir serum concentrations in lung transplant patients receiving valganciclovir prophylaxis.…”

Section: Discussionmentioning

confidence: 99%

Trough ganciclovir concentration as predictor of leukopenia in lung transplant recipients receiving valganciclovir prophylaxis

Katada,

Nakagawa,

Nagao

et al. 2023

Transplant Infectious Dis

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BackgroundValganciclovir is the first‐line agent for Cytomegalovirus prophylaxis after lung transplantation. However, its use is associated with a relatively high risk of hematological toxicity. This study aimed to investigate the relationship between trough ganciclovir concentration and hematologic toxicity in lung transplantation patients receiving valganciclovir prophylaxis, and identify factors that affect ganciclovir pharmacokinetics in this population.MethodsThis prospective observational study included 24 lung transplant patients receiving valganciclovir prophylaxis. The cutoff value of trough ganciclovir concentration was estimated using receiver operating characteristic analysis in leukopenia grade 3 and higher. Population pharmacokinetic analysis was performed using a nonlinear mixed‐effects modeling program.ResultsThe trough ganciclovir concentration was significantly higher in the group with leukopenia grades 3 or higher than in the group with grades less than or equal to 2 (1605.7 ± 860.1 ng/mL [n = 3] vs. 380.5 ± 175.8 ng/mL (n = 21), p < .001). The cutoff value of trough ganciclovir concentration for predicting greater than or equal to grade 3 leukopenia was estimated as 872.0 ng/mL. Creatinine clearance and lung re‐transplantation were found to have a significant impact on the total body clearance of valganciclovir. Ganciclovir clearance was decreased in patients with reduced creatine clearance or re‐transplantation.ConclusionThese results suggest that higher ganciclovir trough concentrations are associated with an increased risk of leukopenia grade 3 or higher, and that creatinine clearance and lung re‐transplantation affected the pharmacokinetics of ganciclovir. image

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Comparison of standard versus low‐dose valganciclovir regimens for cytomegalovirus prophylaxis in high‐risk liver transplant recipients

Cited by 6 publications

References 21 publications

Incidence and risk factors for the development of cytomegalovirus viremia in a steroid sparing liver transplant center

Incidence and risk factors for the development of cytomegalovirus viremia in a steroid sparing liver transplant center

Reduced dosing versus full dosing valganciclovir for prophylaxis of cytomegalovirus in high‐risk abdominal transplant recipients

Trough ganciclovir concentration as predictor of leukopenia in lung transplant recipients receiving valganciclovir prophylaxis

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