Valacyclovir for Cytomegalovirus Prophylaxis Reduces the Risk of Acute Renal Allograft Rejection

Reischig, Tomáš; Jindra, Pavel; Mareš, J; Cechura, M; Švecová, Miroslava; Hes, Ondřej; Opatrný, K; Třeška, Vladislav

doi:10.1097/01.tp.0000150024.01672.ca

Cited by 65 publications

(63 citation statements)

References 35 publications

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“…Both drugs are currently recommended for CMV prophylaxis in renal transplant recipients (1). Just like valganciclovir, valacyclovir was compared with oral ganciclovir after solid organ transplantation; both agents were found to be comparably effective in the prevention of CMV viremia and disease (19,22,23). Consistent with this finding, our data did not document a major reduction in the incidence of CMV DNAemia in a head-to-head comparison of valganciclovir and valacyclovir.…”

Section: Discussionsupporting

confidence: 79%

“…Likewise, management of neutropenia was more challenging with valganciclovir, requiring more frequent therapy with granulocyte colony-stimulating factor and discontinuation of valganciclovir. Inconsistent with earlier reports, the incidence of psychiatric adverse events was not increased with valacyclovir (16,17,19). This may have been because of deferred valacyclovir prophylaxis in patients with delayed or slow graft function until the end of the first post-transplant week.…”

Section: Discussionsupporting

confidence: 58%

“…It should be noted that an earlier head-to-head comparison of valacyclovir with oral ganciclovir did not show a difference in the incidence of acute rejection (22); our earlier data even showed a lower incidence of acute rejection with valacyclovir. However, the increase in the incidence of acute rejection with oral ganciclovir was only because of the higher proportion of patients with delayed graft function (19). Systemic exposure to ganciclovir at standard valganciclovir doses is significantly higher compared with oral ganciclovir (23); hence, the effect on lymphocyte function need not necessarily be identical.…”

Section: Discussionmentioning

confidence: 98%

“…The anticipated CMV DNAemia and BPAR rates in the valacyclovir group were 60% and 12%, respectively (16,19). To detect a reduction in the incidence of CMV DNAemia to 35% and an increase in the incidence of BPAR to 30% in the valganciclovir group, it was necessary to enroll at least 60 and 72 patients, respectively, to ensure 80% power for detection of a treatment difference with type 1 error of 0.05.…”

Section: Sample Size and Statistical Analysesmentioning

confidence: 99%

“…Some centers could find valacyclovir to be an attractive option for economic reasons or because of less bone marrow suppression (18). In addition, valacyclovir has been associated with a lower incidence of acute rejection episodes in several studies (16,17,19), with the efficacy of valacyclovir comparable with that of oral ganciclovir (19). However, there has been no randomized study designed to make a head-to-head comparison of valacyclovir with valganciclovir to date.…”

Section: Introductionmentioning

confidence: 99%

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Randomized Trial of Valganciclovir Versus Valacyclovir Prophylaxis for Prevention of Cytomegalovirus in Renal Transplantation

Reischig

Kacer

Jindra

et al. 2015

Clinical Journal of the American Society of Nephrology

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Background and objectives Both valganciclovir and high-dose valacyclovir are recommended for cytomegalovirus prophylaxis after renal transplantation. A head-to-head comparison of both regimens is lacking. The objective of the study was to compare valacyclovir prophylaxis with valganciclovir, which constituted the control group.Design, settings, participants, & measurements In a randomized, open-label, single-center trial, recipients of renal transplants (recipient or donor cytomegalovirus-seropositive) were randomly allocated (1:1) to 3-month prophylaxis with valacyclovir (2 g four times daily) or valganciclovir (900 mg daily). Enrollment occurred from November of 2007 to April of 2012. The primary end points were cytomegalovirus DNAemia and biopsy-proven acute rejection at 12 months. Analysis was by intention to treat. ResultsIn total, 119 patients were assigned to valacyclovir (n=59) or valganciclovir prophylaxis (n=60). Cytomegalovirus DNAemia developed in 24 (43%) of 59 patients in the valacyclovir group and 18 (31%) of 60 patients in the valganciclovir group (adjusted hazard ratio, 1.35; 95% confidence interval, 0.71 to 2.54; P=0.36). The incidence of cytomegalovirus disease was 2% with valacyclovir and 5% with valganciclovir prophylaxis (adjusted hazard ratio, 0.21; 95% confidence interval, 0.01 to 5.90; P=0.36). Significantly more patients with valacyclovir prophylaxis developed biopsy-proven acute rejection (18 of 59 [31%] versus 10 of 60 [17%]; adjusted hazard ratio, 2.49; 95% confidence interval, 1.09 to 5.65; P=0.03). The incidence of polyomavirus viremia was higher in the valganciclovir group (18% versus 36%; adjusted hazard ratio, 0.43; 95% confidence interval, 0.19 to 0.96; P=0.04).Conclusions Valganciclovir shows no superior efficacy in cytomegalovirus DNAemia prevention compared with valacyclovir prophylaxis. However, the risk of biopsy-proven acute rejection is higher with valacyclovir.

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Section: Discussionsupporting

confidence: 79%

Section: Discussionsupporting

confidence: 58%

Section: Discussionmentioning

confidence: 98%

Section: Sample Size and Statistical Analysesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Randomized Trial of Valganciclovir Versus Valacyclovir Prophylaxis for Prevention of Cytomegalovirus in Renal Transplantation

Reischig

Kacer

Jindra

et al. 2015

Clinical Journal of the American Society of Nephrology

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Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients

Hodson

Craig

Strippoli

et al. 2008

Cochrane Database of Systematic Reviews

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Cochrane Database of Systematic Reviews Main resultsThirty two trials (3737 participants) were identified. Prophylaxis with aciclovir, ganciclovir or valaciclovir compared with placebo or no treatment significantly reduced the risk for CMV disease (19 trials; RR 0.42, 95% CI 0.34 to 0.52), CMV infection (17 trials; RR 0.61, 95% CI 0.48 to 0.77), and all-cause mortality (17 trials; RR 0.63, 95% CI 0.43 to 0.92) primarily due to reduced mortality from CMV disease (seven trials; RR 0.26, 95% CI 0.08 to 0.78). Prophylaxis reduced the risk of herpes simplex and herpes zoster disease, bacterial and protozoal infections but not fungal infection, acute rejection or gra loss. Meta-regression showed no significant di erence in the risk of CMV disease or allcause mortality by organ transplanted or CMV serostatus; no conclusions were possible for CMV negative recipients of negative organs. In direct comparison trials, ganciclovir was more e ective than aciclovir in preventing CMV disease (seven trials; RR 0.37, 95% Cl 0.23 to 0.60).Valganciclovir and intravenous ganciclovir were as e ective as oral ganciclovir. Authors' conclusionsProphylaxis with antiviral medications reduces CMV disease and CMV-associated mortality in solid organ transplant recipients. They should be used routinely in CMV positive recipients and in CMV negative recipients of CMV positive organ transplants.

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Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients

Hodson

Ladhani

Webster

et al. 2013

Cochrane Database of Systematic Reviews

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Valacyclovir for Cytomegalovirus Prophylaxis Reduces the Risk of Acute Renal Allograft Rejection

Cited by 65 publications

References 35 publications

Randomized Trial of Valganciclovir Versus Valacyclovir Prophylaxis for Prevention of Cytomegalovirus in Renal Transplantation

Randomized Trial of Valganciclovir Versus Valacyclovir Prophylaxis for Prevention of Cytomegalovirus in Renal Transplantation

Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients

Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients

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