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

Wang, Xin; Yang, Hui; Zhang, Xiao Dong; Cui, Xiangli; Wang, Shihui

doi:10.18433/j3805b

Cited by 16 publications

(12 citation statements)

References 25 publications

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“…We identified 5 published studies in intermediate-risk kidney transplant recipients: 3 involved 6-month prophylaxis, 8,10,14 and the other two involved 3-month prophylaxis, 12,13 one of which did not adjust for confounders. 13 All aforementioned reports indicated that the effectiveness of LD-VGC was at least comparable to that of SD-VGC prophylaxis, in agreement with our findings and those of two recent meta-analyses with direct or indirect comparisons between SD and LD-VGC prophylaxis, 9,17 one that focused specifically on intermediate-risk kidney transplant recipients. 17…”

Section: Discussionsupporting

confidence: 89%

“…13 All aforementioned reports indicated that the effectiveness of LD-VGC was at least comparable to that of SD-VGC prophylaxis, in agreement with our findings and those of two recent meta-analyses with direct or indirect comparisons between SD and LD-VGC prophylaxis, 9,17 one that focused specifically on intermediate-risk kidney transplant recipients. 17…”

Section: Discussionsupporting

confidence: 89%

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Low-Dose Valganciclovir Prophylaxis Is Safe and Cost-Saving in CMV-Seropositive Kidney Transplant Recipients

et al. 2021

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Introduction: Observational studies suggest that low-dose valganciclovir prophylaxis (450 mg daily for normal renal function) is as effective as and perhaps safer than standard-dose valganciclovir (900 mg daily) in preventing CMV infection among kidney transplant recipients. However, this practice is not supported by current guidelines due to concerns for breakthrough infection from resistant CMV, mainly in high-risk CMV donor-seropositive/recipient-seronegative kidney transplant recipients. Standard-dose valganciclovir is costly and possibly associated with higher incidence of neutropenia and BKV DNAemia. Our institution adopted low-dose valganciclovir prophylaxis for intermediate-risk (seropositive) kidney transplant recipients in January 2018. Research Question: To analyze the efficacy (CMV DNAemia), safety (BK virus DNAemia, neutropenia, graft loss, and death), and cost savings associated with this change. Design: We retrospectively compared the above outcomes between CMV-seropositive kidney transplant recipients who received low-dose and standard-dose valganciclovir, transplanted within our institution, between 1/19/2014 and 7/15/2019, using propensity score-adjusted competing risk analyses. We also compared cost estimates between the two dosing regimens, for 3 months of prophylaxis, and for different percentage of patient-weeks with normal renal function, using the current average wholesale price of valganciclovir. Results: We studied 179 CMV-seropositive kidney transplant recipients, of whom 55 received low-dose and 124 standard-dose valganciclovir. The majority received nonlymphocyte depleting induction (basiliximab). Low-dose valganciclovir was at least as effective and safe as, and more cost-saving than standard-dose valganciclovir. Conclusion: This single-center study contributes to mounting evidence for future guidelines to be adjusted in favor of low-dose valganciclovir prophylaxis in CMV-seropositive kidney transplant recipients.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 89%

Low-Dose Valganciclovir Prophylaxis Is Safe and Cost-Saving in CMV-Seropositive Kidney Transplant Recipients

et al. 2021

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“…Additionally, 2% acute rejection, 8% PTDM, 1% graft loss and 98% patient survival rates were observed in the low-dose group and no statistically significant difference was observed when compared to the high-risk patients 13 . In a recent meta-analysis, patients receiving low-dose and highdose valganciclovir were compared, and no statistically significant differences were observed with respect to CMV disease (p=0.36 for 1271 patients), acute rejection (p=0.19 for 1343 patients), graft loss (p=0.24 for 1271 patients), mortality (p=0.23 for 1271 patients), opportunistic infections (p=0.14 for 985 patients), and leukopenia (p=0.18 for 1082 patients) 14 . In our study, the rate of CMV disease was found to be 1.5% (n=1/68) in renal transplant recipients with low dose valganciclovir prophylaxis, similar to the rates in the literature 15 .…”

Section: Discussionmentioning

confidence: 99%

Renal transplant alıcılarında düşük doz valgansiklovir profilaksisinin etkinliği ve güvenilirliği

Sayilar¹,

Ergun²

2020

Cukurova Medical Journal

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Öz Purpose: Cytomegalovirus (CMV) infection is one of the most common infections observed following kidney transplantations. Transplantations between cytomegalovirus (Immunoglobulin G)-seropositive donor and CMV-seropositive recipient (D+/R+) are considered to be of moderate risk. In our study, we investigated the efficacy of low-dose (450 mg/g) valganciclovir in CMV chemoprophylaxis in renal transplant patients over their first post-transplant year. Materials and Methods: A total of 68 consecutive patients aged over 18 years who underwent renal transplantation between January 2016 and June 2019 were included in this retrospective study. All patients were administered valganciclovir 450 mg/g, for 100 days. The efficacy of low-dose valganciclovir was determined by whether the patients developed a CMV disease during their first post-transplant year. Results: Only one patient (n=1/68) (1.5%) developed CMV disease. CMV DNA titer was positive on posttransplant day 134 of the patient who had unexplained loss of GFR. CMV disease-related acute rejection, graft loss, leukopenia, post-transplant diabetes mellitus, opportunistic infection, or patient loss was not observed. Conclusion: There are many studies comparing CMV prophylaxis with low and standard dose (450 vs. 900 mg/g) valganciclovir treatment in transplant patients. The results of this study show that low-dose valganciclovir is sufficient for the prophylaxis of CMV disease in D+/R+ mediumrisk patients without leading to any side effects. Further clinical studies with larger patient participation are needed. Amaç: Sitomegalovirüs (CMV) infeksiyonu, böbrek nakli sonrasında en sık görülen infeksiyonlardan biridir. Sitomegalovirüs (Immunglogulin G)-seropozitif donör ve CMV-seropozitif alıcı (D+/A+) arasında yapılan nakiller orta riskli kabul edilmektedir. Çalışmamızda renal transplantasyon yapılmış hastalarda nakil sonrası 1 yıllık dönem için düşük doz (450 mg/g) valgansiklovirin CMV kemoprofilaksindeki etkinliğini araştırdık. Gereç ve Yöntem: Ocak 2016 ile Haziran 2019 tarihleri arasında böbrek nakli yapılmış 18 yaş üzerinde ardışık 68 hasta retrospektif olarak çalışmaya dahil edildi. Tüm hastalara 100 gün süreyle 450 mg/g valgansiklovir tedavisi verildi. Düşük doz valgansiklovirin etkinliği hastaların posttransplant 1 yıl içerisinde CMV hastalığı geçirip geçirmemeleri dikkate alınarak belirlendi. Bulgular: Sadece bir hastada (n=1/68) (%1,5) CMV hastalığı gelişti. Nakil sonrası 134. günde nedeni açıklanamayan GFR kaybı olan hastanın CMV DNA titresi pozitif geldi. Tüm grupta CMV hastalığı ilişkili akut rejeksiyon, graft kaybı, lökopeni, PTDM, fırsatçı infeksiyon veya hasta kaybı gelişmedi. Sonuç: Literatürde transplant hastalarında CMV profilaksisi için düşük doz (450 mg/g) valgansiklovir tedavisinin standart doz (900 mg/g) ile karşılaştıran çok sayıda araştırma mevcuttur. Çalışmamızda düşük doz valgansiklovirin D+/A+ orta riskli hastalarda CMV hastalığının profilaksisi için yeterli olduğu ve yan etkiye yol açmadığını gördük. Bu konu ile ilgili geniş hasta katılımlı k...

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“…Valganciclovir 450mg daily is also effective for CMV prophylaxis and is associated with lower risk for hematological side effects than the high dose (Gabardi et al, 2015;Halim et al, 2016;Heldenbrand et al, 2016;Stevens et al, 2015). According to a systematic review and meta-analysis, valganciclovir 900mg and 450mg daily dosing are equipotent for CMV prophylaxis in allrisk renal transplant recipients at least within the first year of transplantation with no differences regarding acute rejection, allograft loss, mortality, opportunistic infections, premature discontinuation of valganciclovir treatment and leukopenia (Xin et al, 2017). However, major concerns with the 450mg daily dose are higher risk of ganciclovir resistance and breakthrough infection among CMV donor-positive/recipient-negative (D+/R-) kidney transplant recipients (Gabardi et al, 2015;Stevens et al, 2015).…”

Section: Discussionmentioning

confidence: 99%

Persistent primary cytomegalovirus infection in a kidney transplant recipient: Multi-drug resistant and compartmentalized infection leading to graft loss

Andrei

Loon²,

Lerut³

et al. 2019

Antiviral Research

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Cytomegalovirus (CMV) is one of the most common opportunistic infections after transplantation. To prevent CMV infections, universal prophylaxis and pre-emptive therapy with ganciclovir or its prodrug valganciclovir is applied. However, prolonged antiviral therapy may result in drug-resistance emergence. We describe a case of a 43-year-old CMV-seronegative patient who underwent kidney transplantation from a CMV-seropositive donor and developed CMV disease despite valganciclovir prophylaxis. CMV viral load increased even though valgangiclovir dose was augmented and immunosuppressive therapy reduced. CMV genotyping revealed mutations in the viral UL97 protein kinase, explaining ganciclovir-resistant CMV infection. The viral load failed to respond to foscavir, cidofovir and CMV-neutralizing immunoglobulins. Kidney allograft dysfunction developed 3 months post-transplantation with a histopathologic diagnosis of CMV nephropathy and potentially concomitant T-cell mediated rejection. A transplantectomy was performed on day 164 post-transplantation since the patient had uncontrollable CMV disease associated with a circulating multidrug-resistant DNA polymerase-mutant virus. Detailed monitoring in this patient demonstrated hallmarks of complicated CMV disease: (i) relatively rapid evolution of drug-resistant CMV mutants in the setting of persistent high blood viral loads, (ii) emergence of viral drug-resistance linked to acute graft rejection, (iii) transient and, thereafter, lack of response to various anti-CMV treatments, (iv) compartmentalization and heterogeneity of CMV viral populations, (v) possible differential ability of viral mutants to cause disease in the graft, and (vi) detection of minor viral variants by next generation

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

Cited by 16 publications

References 25 publications

Low-Dose Valganciclovir Prophylaxis Is Safe and Cost-Saving in CMV-Seropositive Kidney Transplant Recipients

Low-Dose Valganciclovir Prophylaxis Is Safe and Cost-Saving in CMV-Seropositive Kidney Transplant Recipients

Renal transplant alıcılarında düşük doz valgansiklovir profilaksisinin etkinliği ve güvenilirliği

Persistent primary cytomegalovirus infection in a kidney transplant recipient: Multi-drug resistant and compartmentalized infection leading to graft loss

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