Ganciclovir and Valganciclovir Use in Children

Marcia L. Buck, Pharm.D., FCCP, FPPAG

Disclosures

Pediatr Pharm. 2009;15(10) 

In This Article

Clinical Studies in Children

The first report of ganciclovir treatment in an infant with CMV was published in 1988.[9] Since that time, a variety of case reports and clinical studies have been published describing the use of ganciclovir in infants and children. In addition, a small number of papers have documented the efficacy of valganciclovir. The efficacy of valganciclovir as prophylaxis for CMV in pediatric liver transplant patients was evaluated by Clark and colleagues in 2004. In their retrospective study, the authors evaluated 10 children (mean age 4.9±5.6 years). The majority of the patients (50%) were CMV negative and received a CMV positive organ. All of the children were receiving steroids and tacrolimus, with 30% also getting mycophenolate. Patients received a valganciclovir dose of 15 to 18 mg/kg given once daily. All patients tolerated valganciclovir, with no reports of bone marrow suppression or renal dysfunction. Asymptomatic CMV infection was detected on routine CMV antigenemia in one child at one week of treatment, but cleared with a dose increase to 15 mg/kg twice daily. After three negative tests, the dose was reduced to once daily. Based on their initial experience, the authors suggest that valganciclovir is an acceptable therapy for CMV prophylaxis in pediatric transplant patients.

Valganciclovir has also been used successfully in the treatment of infants with congenital CMV infection. In 2007, Galli and colleagues treated 8 infants with severe CMV disease with IV ganciclovir for 1 week followed by oral valganciclovir for 5 weeks. The first four infants were treated with 15 mg/kg once daily, but this resulted in a suboptimal mean maximum concentration of 0.42 mcg/mL (range 0.40–0.74 mcg/mL). Dosing for the second group of four infants was increased to 15 mg/kg twice daily, which produced a maximum concentration of 3.1 mcg/mL (range 2.5–3.9 mcg/mL). Average urine CMV viral load prior to treatment was 6.9±1.32 copies/mL. Viral load lowered during treatment to 3.72±0.71 and 2.66±0.51 copies/mL in the two groups, respectively).

The most current research with these agents has focused on optimizing drug administration. In a study published last year in Transplantation, Gerna and colleagues conducted a randomized, open-label study of ganciclovir prophylaxis versus preemptive therapy along for prevention of CMV in pediatric liver transplant patients. Twenty-one children were randomized to receive either ganciclovir 5 mg/kg twice daily for 30 days (prophylaxis) or preemptive therapy, where treatment was initiated only after the CMV viral load reached 100,000 DNA copies/mL and stopped when two consecutive tests were below the cut-off. At the 24 month interim analysis, similar numbers of patients in each group had developed CMV disease, 7 of the 10 children (70%) in the prophylaxis group and 9 of the 11 (81%) in the preemptive group; however, infection occurred significantly later in the prophylaxis arm (54 versus 24 days, p = 0.05). There was no difference in overall response to infection. As a result, the authors suggest that long-term prophylaxis may not be necessary.

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