Opportunistic CMV viremia (primary infection or reactivation) is usually managed by taking prophylactic medication for both adult and pediatric kidney transplant patients. Most hospitals prescribe valganciclovir for this purpose but valacyclovir has also been used. The most unfavorable side effect of valganciclovir is bone marrow suppression which can be troublesome for kidney transplant patients who are already immunosuppressed. We aim to assess the non-inferiority of valacyclovir compared with valganciclovir in this study.
Age at least 3 years of age
Patients who are about to receive or just received kidney transplantation within the past 2 weeks before the date of screening.
Will be receiving prophylactic antiviral therapy against CMV and/or EBV per discretion of transplant surgeon
No active CMV or EBV viremia (as defined by detectable viral load PCR) at the time of screening.
Severe co-morbidities that would preclude safe participation as judged by the transplant surgeon
Pregnancy (valganciclovir is likely teratogenic)
Known allergy to both valacyclovir and valganciclovir
Parallel
Valacyclovir (Valtrex)
DrugStandard adult dose will be 1000 mg orally twice daily. For pediatric patients, dosing will be weight-based 20 mg/kg/dose twice daily; maximum dose: 1000 mg/dose. The exact dosage will be adjusted for renal function based on published guidelines.
Valganciclovir (Valcyte)
DrugDosing: Standard adult dose will be 450 mg orally once daily. For pediatric patients, dosing will be weight-based 15 mg/kg/dose once daily; maximum dose: 450 mg/dose. The exact dosage will be adjusted for renal function based on published guidelines. For pediatric patients who could not swallow pills, Valcyte also comes in the form of suspension (prepared by National Taiwan University Hospital in-house pharmacy).
Time to new-onset CMV viremia
Time to new-onset EBV viremia
Cumulative incidence of new-onset CMV viremia
Cumulative incidence of new-onset EBV viremia
Bone Marrow Suppression
The cumulative incidence of specific cytopenia (leukopenia, neutropenia, thrombocytopenia and anemia respectively) in each treatment arm will be compared.
Significantly declined renal function at 2 years post-transplant
The incidence of significant decline in renal function (e.g., \>20% decrease from baseline or progression to CKD stage 5) will be compared between groups
Other adverse events during study period
The incidence of other adverse events will be tabulated and compared between groups
Magnitude of Viral Load in New-Onset CMV Viremia
For patients who develop new-onset CMV viremia, the peak CMV viral load (IU/mL) during the viremic episode will be identified.
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