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An Evaluation of the Safety, Efficacy, and Pharmacoeconomics of Two Valganciclovir Prophylaxis Regimens Following Renal Transplantation.

J. Chen,1 R. Hoffman,2 M. Thomas,2 J. Gervasio.2

1IU Health, University Hospital, Indianapolis, IN
2Butler University, Indianapolis, IN.

Meeting: 2016 American Transplant Congress

Abstract number: C276

Keywords: Cytomeglovirus, Kidney transplantation, Prophylaxis

Session Information

Date: Monday, June 13, 2016

Session Name: Poster Session C: Viruses and SOT

Session Time: 6:00pm-7:00pm

 Presentation Time: 6:00pm-7:00pm

Location: Halls C&D

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Valganciclovir is the preferred prophylactic therapy for the prevention of CMV in transplant recipients and is the most expensive medication required post transplantation. The objective of this retrospective study was to investigate the efficacy and safety of delaying initiation of valganciclovir prophylaxis until day after discharge or postoperative day 7, whichever is earlier, and to evaluate the cost savings associated with this strategy.

The medical records of all renal transplant recipients performed at a single center between January 1, 2014 through June 30, 2014 with at least 1 year of follow up were reviewed. Immunosuppression included rabbit anti-thymocyte globulin (6 mg/kg) induction, rapid steroid withdrawal and maintenance therapy of tacrolimus and mycophenolate. Valganciclovir prophylaxis started on either postoperative day 2 or delayed until postoperative day 7 or day after discharge, utilizing a regimen of 450 mg daily for CrCl > 40 mL/min and 450 mg every other daily for CrCl < 40 mL/min. D+/R- receive 6 months prophylaxis vs 3 months for all others.

A total of 80 patients met the inclusion criteria with 38 in the day 2 group and 42 in the day 7 or discharge group. Fisher's exact test was be used to evaluate groups (alpha=0.05). SAS v. 9.3 was used for statistical analysis.

Four patients in the day 7 group developed CMV infection vs 0 patients in the day 2 group (P=0.12). None of the infections occurred during prophylaxis (3 infections in d+/r- recipients at 7, 8, and 8 months post transplant respectively and 1 infection in d+/r+ at 7 months). There were no deaths or graft losses due to CMV in either group. Overall 1 year rejection rate in both groups was 20%; there was no difference between groups in the incidence of rejection(p=.41). Overall one year graft survival was 99% and patient survival 100%.

Average cost savings was determined based on the number of valganciclovir doses given inpatient for either protocol. Cost analysis revealed that an estimated $12,896 in drug expenditures was saved by switching to the POD7 regimen. Based on the average number of renal transplants performed at this center (n=205), delaying initiation of prophylaxis until postoperative day 7 or discharge is associated with an annual cost savings of $62,945 to this institution without sacrificing efficacy and safety.

CITATION INFORMATION: Chen J, Hoffman R, Thomas M, Gervasio J. An Evaluation of the Safety, Efficacy, and Pharmacoeconomics of Two Valganciclovir Prophylaxis Regimens Following Renal Transplantation. Am J Transplant. 2016;16 (suppl 3).

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To cite this abstract in AMA style:

Chen J, Hoffman R, Thomas M, Gervasio J. An Evaluation of the Safety, Efficacy, and Pharmacoeconomics of Two Valganciclovir Prophylaxis Regimens Following Renal Transplantation. [abstract]. Am J Transplant. 2016; 16 (suppl 3). https://atcmeetingabstracts.com/abstract/an-evaluation-of-the-safety-efficacy-and-pharmacoeconomics-of-two-valganciclovir-prophylaxis-regimens-following-renal-transplantation/. Accessed March 8, 2021.

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