Increased risk of breakthrough infection among cytomegalovirus donor‐positive/recipient‐negative kidney transplant recipients receiving lower‐dose valganciclovir prophylaxis

Stevens, Daniel R.; Sawinski, Deirdre; Blumberg, Emily A.; Galanakis, Nearchos; Bloom, Roy D.; Trofe‐Clark, Jennifer

doi:10.1111/tid.12349

Cited by 74 publications

(75 citation statements)

References 32 publications

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“…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%

See 2 more Smart Citations

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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“…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%

See 1 more Smart Citation

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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“…Recent studies have highlighted a benefit of long-term high-dose valganciclovir prophylaxis (6 mo) in terms of CMV disease occurrence and to avoid breakthrough infections among D+/R− patients; however, recommendations regarding treatment of intermediate-risk kidney transplant recipients are still unclear. 43,44 Our study demonstrated a numerically lower incidence of CMV infections with steady 6-month low-dose valganciclovir among an intermediate-risk group with better safety profile compared with the high-dose regimen.…”

Section: Cytomegalovirus Diseasementioning

confidence: 86%

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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“…12 However, this treatment is not fully effective and can be associated with adverse bone marrow events, which may lead to dose decrease or dose discontinuation, to late-onset CMV infection, and in some cases to drug resistance. [13][14][15][16] Preemptive therapy does not prevent viral replication, an event that has been associated with inferior transplant outcomes, and also requires intensive logistic coordination. 15,[17][18][19][20] A third strategy has also emerged, which is to use a mammalian target of rapamycin (mTOR) inhibitor in the immunosuppressive regimen (ie, either sirolimus or everolimus), as suggested by recent data.…”

Section: Introductionmentioning

confidence: 99%

Untitled

Malvezzi

Jouve²,

Rostaing³

2016

Exp Clin Transplant

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Objectives: Cytomegalovirus infection and disease remain an issue in solid-organ transplant. Universal prophylaxis is more cost-effective than a preemptive strategy and is associated with significantly less cytomegalovirus resistance after kidney transplant, especially in cytomegalovirus-seropositive donors and cytomegalovirus-seronegative recipients. Materials and Methods: Registry data and metaanalyses have shown that mammalian target of rapamycin inhibitors (sirolimus-and everolimus-based immunosuppression) are associated with significantly less cytomegalovirus events in de novo kidney transplant patients than in patients who are treated with calcineurin inhibitors plus mycophenolate-based immunosuppression. Results: Recent pooled analyses of 3 randomized controlled trials in de novo kidney transplant patients, where immunosuppression was based on cyclosporine with either mycophenolate or everolimus, showed that patients who received everolimus had significantly less cytomegalovirus events (cytomegalovirus viremia, cytomegalovirus infection/disease) than those who received mycophenolate, with or without cytomegalovirus as prophylaxis. An even more recent prospective randomized controlled study on de novo kidney transplant patients with no anticytomegalovirus prophylaxis demonstrated that everolimus-based immunosuppression plus low-dose tacrolimus was associated with significantly less cytomegalovirus infection than standard-dose tacrolimus plus mycophenolate. Conclusions: The potential benefits are not fully known of such a therapeutic strategy to limit the longterm indirect effects mediated by cytomegalovirus infections.

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Increased risk of breakthrough infection among cytomegalovirus donor‐positive/recipient‐negative kidney transplant recipients receiving lower‐dose valganciclovir prophylaxis

Cited by 74 publications

References 32 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

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