Evaluation of Low- Versus High-dose Valganciclovir for Prevention of Cytomegalovirus Disease in High-risk Renal Transplant Recipients

Gabardi, Steven; Asipenko, Natalya; Fleming, James N.; Lor, Kevin W.; Potter, Lisa; Mohammed, Anisa; Rogers, Cathy; Tichy, Eric M.; Weng, Renee; Lee, Ruth Ann

doi:10.1097/tp.0000000000000570

Cited by 44 publications

(55 citation statements)

References 22 publications

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“…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%

“…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.…”

Section: Study Descriptionmentioning

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: Infectionmentioning

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.…”

Section: Study Descriptionmentioning

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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“…Our results suggest that low-dose valganciclovir prophylaxis may have the same effect as a high dose, with favorable economic benefits as concluded from other studies. 45 A formal cost-effective analysis of the data from this study is currently in progress.…”

Section: Study Limitationsmentioning

confidence: 99%

Untitled

Halim

Al-Otaibi²,

Gheith³

et al. 2016

Exp Clin Transplant

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Objectives: Prophylaxis for cytomegalovirus infection is highly recommended for kidney transplant recipients. The use of daily 900 mg valganciclovir is the usual prophylactic dose, whereas 450 mg daily is under investigation. We evaluated the outcome of using 2 different doses of valganciclovir prophylaxis for cytomegalovirus infection after kidney transplant. Materials and Methods: We randomized kidney transplant recipients (1:1) to receive 450 mg daily valganciclovir (group 1) or 900 mg daily valganciclovir (group 2) for the first 6 months after kidney transplant. Serologically, all patients were at moderate risk for cytomegalovirus infection. Patients were studied for incidence of cytomegalovirus disease, leukopenia attacks, rejection episodes, and graft outcomes for 1 year. Results: Demographic features of group 1 (98 patients) and group 2 (98 patients) were comparable. More than 50% of patients received thymoglobulin induction therapy without difference between the groups. There were more leukopenia attacks in group 2 (P = .03) requiring higher doses of granulocyte colonystimulating factor (P = .03). Group 2 patients received lower doses of mycophenolate mofetil (P= .04) and required reduced doses of valganciclovir (P = .045). Compared with group 1, the high-dose group developed numerically more rejection episodes (P = .057) and more cytomegalovirus infections requiring full treatment (P = .17). Graft and patient outcomes were satisfactory in both groups. Conclusion:Six months of low-dose valganciclovir prophylaxis for intermediate-risk kidney transplant recipients was as effective as high-dose valganciclovir with a better safety profile.

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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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Evaluation of Low- Versus High-dose Valganciclovir for Prevention of Cytomegalovirus Disease in High-risk Renal Transplant Recipients

Cited by 44 publications

References 22 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

Untitled

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

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