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Valganciclovir prophylaxis versus preemptive therapy in cytomegalovirus-positive renal allograft recipients: Long-term results after 7 years of a randomized clinical trial.

Valganciclovir prophylaxis versus preemptive therapy in cytomegalovirus-positive renal allograft recipients: Long-term results after 7 years of a randomized clinical trial.
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Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V,


Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V, (click to view)

Witzke O, Nitschke M, Bartels M, Wolters H, Wolf G, Reinke P, Hauser IA, Alshuth U, Kliem V,

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Transplantation 2017 11 22() doi 10.1097/TP.0000000000002024

Abstract
BACKGROUND
The VIPP study compared valganciclovir prophylaxis with preemptive treatment regarding efficacy, safety and long-term graft outcome in CMV-positive (R+) renal transplant recipients.

METHODS
Multicenter, open-label, randomized clinical study with a 12-month study phase and a follow-up of up to 84 months. Patients in the prophylaxis group received 2×450 mg/day oral valganciclovir for 100 days adjusted to renal function. Preemptive treatment with 2×900 mg/day valganciclovir was initiated at a viral load of ≥400 CMV copies/mL (PCR) and maintained over ≥14 days, followed by secondary prophylaxis. Patients were stratified by donor CMV IgG serostatus (D+/R+, D-/R+).

RESULTS
The 12-month-results were reported previously (Witzke et al Transplantation 2012). The intent-to-treat/safety population comprised 148 patients in the prophylaxis (61.5% D+/R+) and 151 patients in the preemptive group (52.3% D+/R+). Overall, 47% patients completed the follow-up. Significantly fewer patients in the prophylaxis compared to preemptive group experienced a CMV infection or disease up to month 84 (11.5% [95% CI: 6.8%,17.8%] vs. 39.7% [31.9%,48.0%], p<0.0001 and 4.7% [1.9%,9.5%] vs. 15.9% [10.5%,22.7%], p=0.002). Incidences of graft loss (7.4% vs. 8.6%), death (9.5% vs. 11.3%), rejection (29.1% vs. 28.5%), and renal function (eGFR [mean±SD]: 58.2±26.3 vs. 59.9±25.7 mL/min/1.73m) were not significantly different between prophylaxis and preemptive treatment. Tolerability was comparable between groups. CONCLUSIONS
Prophylaxis was more effective than the preemptive approach applying a low intense surveillance protocol in preventing CMV infection and disease in intermediate-risk patients. Both strategies were similarly effective in preventing graft loss and death under the conditions of this long-term trial with a threshold of 400 copies/mL for initiation of anti-CMV treatment.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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