*Purpose: Valganciclovir (valG) is an effective CMV prophylactic agent post-kidney transplant (KTx) with significant side effects. Valacyclovir (valA) may be effective for CMV prophylaxis with improved tolerability in adult and pediatric kidney recipients.

*Methods: In this randomized, open-label trial [NCT01329185], we randomly assigned adult and pediatric KTx recipients (1:1) to valA or valG for CMV prophylaxis post-KTx, in blocks of 2 and 4. Dose was based on estimated GFR and age [as per package insert] and duration on donor-recipient serostatus. Patient outcomes were assessed [Table]. The primary end point was incidence of side-effect related study drug reduction/cessation and the secondary outcome was incidence of CMV viremia / disease.

*Results: Thirty % of the patients were pediatric and 40% female. Patients receiving valA (n=66) and valG (n=71) were similar [Table 4]. Patients were significantly more likely to have a reduction of study drug due to side effects in the valG arm (21%) than valA (2%) (p = 0.0003) with no significant difference in incidence of CMV viremia / disease. The most common reason for valG dose reduction was leucopenia; incidence of leucopenia requiring an intervention such as Filgrastim was significantly higher in valG (25% in valG vs 5% in valA: p=0.0007). There was no significant difference in incidence (p=0.37); time to CMV viremia (p = 0.2); or area under CMV viral load time curve (p=0.2). Sub-analysis of patients that were CMV antibody D+R- demonstrated similar results.

*Conclusions: ValA is as effective as valG in preventing CMV infection post-KTx in adults and children with significantly less dose-limiting side effects.

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