Multicenter evaluation of efficacy and safety of low‐dose versus high‐dose valganciclovir for prevention of cytomegalovirus disease in donor and recipient positive (D+/R+) renal transplant recipients

Heldenbrand, Seth; Li, Chenghui; Cross, Rosemary; DePiero, Kelly A.; Dick, Travis B.; Ferguson, K.; Kim, Min Ji; Newkirk, E.; Park, Jeong Mi; Sudaria-Kerr, Janice; Tichy, Eric M.; Ueda, Kimi; Weng, Renee; Wisniewski, Jesse; Gabardi, Steven

doi:10.1111/tid.12609

Cited by 29 publications

(42 citation statements)

References 33 publications

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“…A total of 3 studies evaluated the allograft loss rate (12,13,16). Incidence of OI showed no significant difference between VGC 450 mg and VGC 900 mg (985 patients, OR 0.76, 95%CI 0.52-1.10, p=0.14; Figure 6).…”

Section: Opportunistic Infectionsmentioning

confidence: 99%

“…Three of these studies reported on high-risk RTR (13,14,17). Three studies (12,15,16) reported on moderate-risk RTR, and one study (11) reported on all risk RTR. The characteristics of the eligible studies were presented in Table 1.…”

Section: Study Descriptionmentioning

confidence: 99%

“…Gruber et al (11) Acute rejection A total of 6 studies evaluated the AR rate (11)(12)(13)(14)(15)(16). Incidence of AR showed that there was no significant difference between VGC 450 mg and VGC 900 mg (1343 patients, OR 0.77, 95%CI 0.53-1.14, p=0.19; Figure 3).…”

Section: Infectionmentioning

confidence: 99%

“…106 articles were excluded after full-text review. Overall, 7 studies with 1431 patients were identified that were eligible for inclusion in the meta-analysis (11)(12)(13)(14)(15)(16)(17). The whole literature search process was summarized in Figure 1.…”

Section: Literature Searchmentioning

confidence: 99%

“…When used for prophylaxis, the usual dose of VGC is 900 mg a day, versus treatment dose which is 900 mg twice daily (both should be adjusted for renal function). Recently, several new studies directly comparing VGC 900 mg with VGC 450 mg daily in RTR have been published (11)(12)(13)(14)(15)(16)(17), and a meta-analysis compared two regimens only be carried in sold organ transplantation (18). Therefore, it is important and necessary to directly assess the benefits and the risks between VGC 450 mg and VGC 900 mg in RTR in order to produce an evidence-based recommendation for clinical practice.…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of Valganciclovir 900mg Versus 450mg for Cytomegalovirus Prophylaxis in Renal Transplantation: A Systematic Review and Meta-Analysis

et al. 2017

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-Objectives:Valganciclovir 900 mg/day is approved for cytomegalovirus (CMV) prophylaxis, but 450 mg/day is seems also effective. We systematically reviewed the efficacy and safety of low-dose versus high-dose valganciclovir prophylaxis in renal transplantation recipients. Methods: An electronic search was conducted up to November 29, 2016. The primary outcomes were incidences of CMV, CMV disease, mortality and opportunistic infection. The second outcomes were acute rejection, allograft loss, adverse drug reaction (ADR). Results: 7 cohort studies, all with high quality involving (1431 patients) were included. There was no significant difference of the incidence of following CMV disease (1271 10, p=0.14) between the low-dose and the high-dose valganciclovir prophylaxis. And no significant difference was observed for premature valganciclovir discontinuation (1010 patients, OR 0.81, 95%CI 0.52-1.25, p=0.33) and the incidence of leukopenia (1082 patients, OR 0.65, 95%CI 0.34-1.22, p=0.18) between the two regimens. Conclusion: 450 mg and 900 mg doses of valganciclovir are equipotent for CMV universal prophylaxis. CMV 450 mg prophylaxis should be used for renal transplant recipients.

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Section: Opportunistic Infectionsmentioning

confidence: 99%

Section: Study Descriptionmentioning

confidence: 99%

Section: Infectionmentioning

confidence: 99%

Section: Literature Searchmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Effectiveness of Valganciclovir 900mg Versus 450mg for Cytomegalovirus Prophylaxis in Renal Transplantation: A Systematic Review and Meta-Analysis

et al. 2017

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Pharmacokinetics, Pharmacodynamics, and Therapeutic Drug Monitoring of Valganciclovir and Ganciclovir in Transplantation

Franck

Autmizguine

Marquet

et al. 2021

Clin Pharma and Therapeutics

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Ganciclovir and valganciclovir are first choice drugs for the prevention and treatment of cytomegalovirus infection and disease in solid organ and stem cell transplant recipients. Only a few studies on the pharmacokinetics and exposure/efficacy or exposure/safety relationships of ganciclovir and valganciclovir in transplant recipients have been published so far, and there are still controversies about the exposure parameter to use for therapeutic drug monitoring (TDM). We performed an extensive literature review of the clinical pharmacokinetics data, the exposure/effect relationships in terms of efficacy and safety, and the available tools for valganciclovir and ganciclovir TDM in adults and pediatrics transplant recipients. The pharmacokinetics of ganciclovir and valganciclovir is well described in adults and children, and a high interindividual variability is commonly observed. In contrast, the drug pharmacodynamics has been poorly described in adults and barely in children. The average 24‐hour area under the concentration‐time curve (AUC0–24h) seems to be the best predictor of efficacy and toxicity. The benefit of TDM remains controversial in adult patients but should be considered in children due to higher interindividual variability and lower probability of target attainment. Several bayesian estimators based on limited sampling strategies have been developed with this aim and may be used in clinical practice for the AUC‐based individual dose adjustment of ganciclovir and valganciclovir.

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Low‐dose valganciclovir for cytomegalovirus prophylaxis in intermediate‐risk liver transplantation recipients

Khan¹,

Sullivan²,

Ali

et al. 2018

Liver Transpl

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Liver transplantation recipients (LTRs) who are seropositive for cytomegalovirus (CMV) (recipient seropositive [R+]) are at intermediate risk for CMV disease. A preventative strategy following transplant is considered standard of care. Current guidelines recommend high-dose valganciclovir (VGCV; 900 mg/day adjusted for renal function) for prophylaxis given limited data on the efficacy and safety of low-dose VGCV (450 mg/day adjusted for renal function). We describe our experience using low-dose VGCV prophylaxis for R+ LTRs at our institution. A single-center, retrospective study was conducted using a database of 364 LTRs over a 4-year period (2011-2014). Adult first-time R+ LTRs receiving low-dose VGCV prophylaxis were included. The primary endpoint was CMV disease at 1 year after transplant. Patients were compared with historical controls receiving high-dose VGCV prophylaxis. Secondary endpoints were biopsy-proven rejection and leukopenia on VGCV. With respect to leukopenia, patients receiving low-dose VGCV were compared with a group of D+R- patients from the database receiving high-dose VGCV. Univariate analyses were performed using chi-squared, Fisher's exact, and Wilcoxon rank sum tests. A total of 200 R+ LTRs met inclusion criteria. Median age was 60 years (interquartile range [IQR], 54-66 years), and 129 (65%) LTRs were male. Median Model for End-Stage Liver Disease score was 22 (IQR, 14-31), and 178 (89%) patients received deceased donor transplants. CMV disease occurred in only 9 (5%) patients, similar to rates in previous studies of LTRs receiving high-dose VGCV. Biopsy-proven rejection occurred in 18 (9%) patients. Patients received VGCV prophylaxis for a median of 3.4 (IQR, 3.1-4.3) months; 151 (76%) R+ LTRs receiving low-dose VGCV developed leukopenia. Premature VGCV discontinuation and granulocyte-colony stimulating factor use were infrequent and not significantly different between the 2 groups. In conclusion, low-dose VGCV was safe and effective for prevention of CMV disease in our cohort of 200 R+ LTR and should be considered as an option in future guidelines. Liver Transplantation 24 616-622 2018 AASLD.

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Multicenter evaluation of efficacy and safety of low‐dose versus high‐dose valganciclovir for prevention of cytomegalovirus disease in donor and recipient positive (D+/R+) renal transplant recipients

Abstract: The occurrence of CMV disease at 12 months was similar between the groups (3.5% vs 3.4%; P=1.000). Log-rank test found no statistically significant difference in the time to development of CMV between the 2 groups (P=.939).

Cited by 29 publications

References 33 publications

Effectiveness of Valganciclovir 900mg Versus 450mg for Cytomegalovirus Prophylaxis in Renal Transplantation: A Systematic Review and Meta-Analysis

Effectiveness of Valganciclovir 900mg Versus 450mg for Cytomegalovirus Prophylaxis in Renal Transplantation: A Systematic Review and Meta-Analysis

Pharmacokinetics, Pharmacodynamics, and Therapeutic Drug Monitoring of Valganciclovir and Ganciclovir in Transplantation

Low‐dose valganciclovir for cytomegalovirus prophylaxis in intermediate‐risk liver transplantation recipients

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