24 weeks of valganciclovir prophylaxis in children after renal transplantation: a 4-year experience
Andres F Camacho-Gonzalez1, Julie Gutman, Leonard C Hymes
1Division of Pediatric Infectious Diseases, Emory University Department of Pediatrics and Children's Healthcare of Atlanta, Atlanta, GA 30322, USA.
Insights
Extended valganciclovir prophylaxis (24 weeks) in pediatric kidney transplant patients effectively prevented cytomegalovirus (CMV) disease during treatment. This longer duration showed a lower rate of late-onset CMV disease compared to shorter regimens.
Area of Science:
- Pediatric Nephrology
- Transplant Infectious Diseases
- Virology
Background:
- Cytomegalovirus (CMV) is a common opportunistic infection post-solid-organ transplant.
- Limited data exist on valganciclovir prophylaxis efficacy in pediatric populations.
- Delayed-onset CMV disease is an emerging concern, prompting investigation into extended prophylaxis.
Purpose of the Study:
- To evaluate the incidence of CMV disease and valganciclovir toxicity in pediatric renal transplant recipients.
- To assess the effectiveness of a 24-week valganciclovir prophylaxis regimen.
- To compare the rate of late-onset CMV disease with historical 12-week regimens.
Main Methods:
- Retrospective analysis of 111 pediatric renal transplant patients (2004-2008).
- Patients received 24 weeks of valganciclovir prophylaxis (15 mg/kg/day, max 900 mg/day).
- Incidence of CMV disease, viremia, and treatment toxicity were measured.
Main Results:
- CMV viremia occurred in 27% and CMV disease in 4.5% of patients.
- No CMV disease was observed during the 24-week prophylaxis period.
- Hematologic toxicity associated with valganciclovir was reported in 24% of patients.
- Donor seropositivity and Thymoglobulin use increased CMV viremia risk.
Conclusions:
- 24-week valganciclovir prophylaxis is effective in preventing CMV disease in pediatric kidney transplant recipients.
- This extended regimen demonstrated a reduced rate of late-onset CMV disease.
- Further studies are warranted to optimize prophylaxis duration, dosage, and assess resistance and cost-effectiveness.
Background:
Cytomegalovirus (CMV) is the most common opportunistic infection after solid-organ transplant. Valganciclovir prophylaxis significantly reduces disease, but limited data are available on its use in children. Recently, an increase in delayed-onset CMV disease has been noted with some arguing that longer prophylaxis may decrease late-onset disease.
Methods:
Single-center, retrospective analysis of pediatric renal transplant patients receiving 24 weeks valganciclovir prophylaxis (15 mg/kg/day, maximum 900 mg/day) from January 2004 to December 2008, aiming to measure the incidence of CMV disease and toxicity of valganciclovir.
Results:
We enrolled 111 patients, 60% males, 46% African Americans, and median age at transplant 14.5 years (range 1.4-20.4 years). Sixty-nine percent of donors and 44% of recipients were seropositive pretransplant. Median duration of valganciclovir use was 5.9 months (range 0.5-24 months). CMV viremia and disease occurred in 27% and 4.5%, respectively. All patients with disease presented after prophylaxis ended and all were D+/R-. Thymoglobulin use (P = 0.04) and positive donor CMV status (P = 0.02) were associated with a higher risk of CMV viremia. Twenty-four percent had hematologic toxicity directly associated with valganciclovir.
Conclusions:
Valganciclovir use in children was effective as prophylaxis against CMV disease; no children at our institution developed disease while on therapy. Our regimen of 24 weeks of prophylaxis was associated with a lower rate of late-onset disease than previous reports with 12-week regimens. Further controlled studies should be considered to compare longer versus shorter periods of prophylaxis and dose reductions and their impact on prevention of late-onset disease, resistance, cost, and toxicity.
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