The correct valganciclovir (vgc) dose for CMV-prophylaxis depends on renal function as assessed by the Cockroft Gault formula (CG-eGFR) for patients (pts) after transplantation (Tx).
We performed a retrospective investigation of vgc dosing of all transplanted pts receiving vgc prophylaxis between August 2003 and August 2011 and analyzed vgc dosing, renal function with different formulas (CG-eGFR, MDRD, Nankivell CKD-EPI), CMV viremia (CMV-PCR >750 copies/ml), CMV infection (=positive PCR and clinical symptoms), leucopenia (<3500/¯o;l), severe leucopenia (<2000/¯o;l) and clinical outcome during the first year post tx.
637 pts received vgc prophylaxis including 103 (16,3%) high risk recipients (D+/R-). 13 pts died and 15 pts experienced graft loss within one year after tx. Vgc prophylaxis lasted 138±78 days (d) with a dose of 211±167mg/d. 113 pts developed CMV viremia (60pts, 53,1%; asymptomatic) after 163±87d post tx, of whom 41 (36,3%) were D+/R-. 44/637 (6,9%) pts required hospitalization due to CMV disease. A total of 176 (27,6%) pts developed mild leucopenia within 106±74d post tx and n=93 (14,6%) severe leucopenia within 101±57d.
At day 30 CG-eGFR was 52,4±25,9ml/min with vgc dose of 269±170mg/d in 623 pts. Only 200/623 (32,1%) pts received the recommended dose for prophylaxis, while n=304 (48,8%) were underdosed and n=119 (19,1%) were overdosed. Similar results were obtained with other formulas except Nankivell formula where 449/583 pts (77%) were underdosed and 41pts (7%) overdosed. At Month 2 and 3 the proportion of patients with recommended dose remained low: 189 pts (32,0%) at day 60 and 179 pts (32,8%) at day 90.
50pts (16,4%) who developed CMV viremia received lower than recommended vgc doses which was not significant different to patients receiving recommended (33pts, 16,5%) or higher (227pts, 22,7%) prophylaxis doses (p=0.187).
Leucopenia was observed more often in patients (83pts, 41,5%) with recommended prophylaxis and in patients (71pts, 59,7%) with higher doses than in patients (106pts, 34,9%) with lower than recommended doses at d30 (p<0.001).
Most pts do not receive the recommended vgc dose adjusted for renal function. Despite obvious underdosing in a large proportion of pts effective prophylaxis was maintained. Occurrence in CMV viremia was comparable but recommended and overdosing was associated with a higher incidence of leucopenia.
Brakemeier, S.: Speaker’s Bureau, Roche. Neumayer, H.: Grant/Research Support, Roche, Speaker’s Bureau, Roche. Budde, K.: Grant/Research Support, Roche, Speaker’s Bureau, Roche.
To cite this abstract in AMA style:Rissling O, Naik M, Brakemeier S, Hohberger A, Neumayer H, Budde K. High Frequency of Valganciclovir Under- and Overdosing for CMV Prophylaxis after Renal Transplantation [abstract]. Am J Transplant. 2013; 13 (suppl 5). http://atcmeetingabstracts.com/abstract/high-frequency-of-valganciclovir-under-and-overdosing-for-cmv-prophylaxis-after-renal-transplantation/. Accessed November 19, 2017.
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