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Abstract

Objectives: Low-dose valganciclovir prophylaxis is still under investigation in renal transplant procedures. Our aim was to assess the cost effectiveness of 450 mg versus 900 mg valganciclovir prophylaxis in kidney transplant recipients. Materials and Methods: In this prospective trial, 201 kidney transplant patients were randomized (1:1) to receive 450 mg/d (group 1, n = 100) or 900 mg/d (group 2, n = 101) valganciclovir prophylaxis for the first 6 months after transplant. Patients were studied for incidence of cytomegalovirus disease, leukopenia episodes, rejection episodes, and graft outcomes along with associated costs over 1 year. Costs (in US dollars) of treatment of rejection were also analyzed. Results: Demographic features of the studied groups were comparable. We found that the cost of cytomegalovirus care in group 1 patients was significantly lower (by 50% at 6 months; P < .001), with less leukopenia episodes (P = .04), lower doses of granulocyte colony-stimulating factor (by 30% at 6 months; P = .03), higher doses of mycophenolate mofetil (P = .04), and less rejection episodes (P = .01) compared with group 2. In group 2, there were more episodes of cytomegalovirus infection (P = .052) and BK virus nephropathy (P = .04). Graft and patient outcomes were satisfactory in both groups. Conclusions: Low-dose valganciclovir for cytomegalovirus prophylaxis after renal transplant is safer, effective and without breakthrough infection, and less costly than using the usual dose.

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

“…The frequencies of CMV DNAemia (3.4%) and syndrome (1.1%) were comparable 8,18 or lower 12,19 than previously reported, which may be related to relatively less ATG use and more liberal immunosuppression in our cohort. However, increased incidence of late CMV infection post-SD prophylaxis was also observed in other studies comparing SD prophylaxis to preemptive treatment, 20 and has been hypothesized to be due to lack of opportunistic low-level CMV DNAemia that could stimulate T-cell immunity and thus prevent downstream late-onset infection and graft rejection.…”

“…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.…”

“…7,8 Low dose-VGC use has been associated with less leukopenia, 9 less or comparable 9,10 risk of graft rejection, and lower incidence of BK nephropathy. 8 However, the most recent guidelines do not support use of LD-VGC 1,6 due to concern for breakthrough infections and resistance in high-risk (D+/R−) organ transplant recipients, 5,11 as well as paucity of high-quality comparison studies in intermediate-risk groups. 8,10,12–14…”

“…8 However, the most recent guidelines do not support use of LD-VGC 1,6 due to concern for breakthrough infections and resistance in high-risk (D+/R−) organ transplant recipients, 5,11 as well as paucity of high-quality comparison studies in intermediate-risk groups. 8,10,12–14…”

Less renal allograft fibrosis with valganciclovir prophylaxis for cytomegalovirus compared to high-dose valacyclovir: a parallel group, open-label, randomized controlled trial

“…While our study was not powered to detect significant differences in the incidence of PVAN, the rates were clinically not negligible with 3 cases of graft loss directly related to PVAN in the valganciclovir group. Also in a recently published study, full dose valganciclovir prophylaxis resulted in higher rates of PVAN [ 37 ]. It is conceivable that valganciclovir had an effect on the BKV-specific cellular immune response making BKV replication more frequent [ 38 , 39 ].…”