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Does Low-Dose Valganciclovir for Cytomegalovirus Prophylaxis Affect Outcomes in Kidney Transplant Recipients?

M. Gillespie, L. Smith, S. Lee, N. Kenyon, C. Truax, J. Corbett, F. Shihab

Solid Organ Transplant, University of Utah Health Care, Salt Lake City, UT

Meeting: 2013 American Transplant Congress

Abstract number: B975

INTRODUCTION: Valganciclovir (VGC) is used for CMV ppx in kidney tx recipients (KTR). Based on previous PK and efficacy studies, a lower potential for AEs and reduced drug costs, our institution uses VGC 450 mg daily for 1 & 3 months in intermediate- (D+/R+, D-/R+) and high-risk (D+/R-) KTR, respectively. CMV infection rates at our institution in KTR were assessed and compared to previously reported results.

METHODS: This retrospective review examined D+/R-, D+/R+, and D-/R+ adult KTR transplanted between 10/1/2007-6/30/2010. Patients were excluded for any of the following: non-renal tx, graft loss/death within 30 days of tx, did not receive CMV ppx per protocol, or if clinical records were not available. CMV infection (CMV viremia detectable by PCR or tissue-invasive infections) 1 year after tx and patient/graft survival and acute rejection 2 years after tx were evaluated.

RESULTS: 70 KTR met inclusion (mean age = 45±16 years; 16 D+/R-, 32 D+/R+, 22 D-/R+; 54.3% female; 82.9% caucasian; 92.9% induction with antilymphocyte antibodies). 10 patients (14.3%) developed CMV infection within 1 year (median time to infection 107 days post-transplant) after tx. Rates of infection at 1 year and patient/graft survival and rejection rate at 2 years in each CMV risk group are described in Table 1. One D+/R- pt developed both tissue-invasive and ganciclovir-resistant infection. In those with CMV, 4 (40%) were on tacrolimus (Tac) and mycophenolate (MPA) while 6 (60%) were on Tac + MPA + prednisone at the time of infection.

CONCLUSIONS: Our findings suggest that VGC 450 mg daily for 1 or 3 months provides adequate ppx against CMV in intermediate-risk pts or high-risk pts, respectively. In D+/R- pts, the 1 year rate of infection appears to be less than the the 1 year rate of CMV disease reported in the IMPACT study for pts receiving 900 mg daily for 100 days (25% vs. 36.8%, respectively) but greater than in those receiving VGC 900 mg daily for 200 days (16.1%). However, patient/graft survival and acute rejection 2 years after tx do not appear to be adversely affected by our protocol.

Outcomes
D/R Serology # of Patients With CMV Infection # of Patients With Infection During Prophylaxis Patient Survival @ 2 Years Graft Survival @ 2 years Rejection @ 2 Years
D+/R- 4 (25%) 2 (12.5%) 16 (100%) 16 (100%) 1 (6.3%)
D+/R+ 3 (9.3%) 0 (0%) 32 (100%) 32 (100%) 3 (9.4%)
D-/R+ 3 (13.6%) 0 (0%) 21 (95.5%) 22 (100%) 0 (0%)
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To cite this abstract in AMA style:

Gillespie M, Smith L, Lee S, Kenyon N, Truax C, Corbett J, Shihab F. Does Low-Dose Valganciclovir for Cytomegalovirus Prophylaxis Affect Outcomes in Kidney Transplant Recipients? [abstract]. Am J Transplant. 2013; 13 (suppl 5). https://atcmeetingabstracts.com/abstract/does-low-dose-valganciclovir-for-cytomegalovirus-prophylaxis-affect-outcomes-in-kidney-transplant-recipients/. Accessed May 14, 2025.

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