Objective: The FDA-approved pediatric indication of valganciclovir (VGCV) is limited to cytomegalovirus (CMV) prophylaxis in heart and kidney transplants. The recommended regimen is a daily dose calculated by 7 x BSA x CrCl [using a modified Schwartz formula (k x ht/Scr), max CrCl of 150 ml/min, and Scr measured by the Jaffe method] for a duration of 100 and 200 days, respectively. Data are scarce on appropriate VGCV dose and duration in pediatric solid organ transplant (SOT) recipients. This study aimed to describe the current VGCV dosing strategies used for CMV prophylaxis and treatment among pediatric SOT centers.

Methods: In November 2017, a survey of pharmacists was conducted through the Internet to assess VGCV dosing and duration strategies for CMV prophylaxis and treatment at pediatric SOT centers in the U.S.

Results: Of 54 centers that perform pediatric SOTs, 23 (42.6%) responded to the survey. Responses were for kidney (n=19), liver (n=15), heart (n=8), small bowel (n=3), and lung (n=1). Thirteen centers (59.1%) reported calculating VGCV dose for CMV prophylaxis using 7 x BSA x CrCl, with 8 centers (61.5%) using a max CrCl of 150 ml/min. Seven (53.8%) used the modified Schwartz formula, 5 (38.5%) used the bedside Schwartz formula (0.413 x ht/Scr), and one center used the modified Schwartz formula for heart and the bedside Schwartz formula for kidney. Only 8 centers (34.8%) reported using the Jaffe method to measure Scr, while a majority (65.2%) were unsure of the assay type used. Others based VGCV dosing on weight (13-16 mg/kg/day) or BSA (900 or 450 mg/1.73 m²/day). The reported duration of VGCV for CMV prophylaxis ranged from 3-12 months. For the treatment of CMV, VGCV dosing also differed across centers, with a majority (43.5%) using 7 x BSA x CrCl.

Conclusion: VGCV dosing strategies for CMV prophylaxis and treatment differed significantly across U.S. pediatric SOT centers and by organ type. Less than two thirds of responding centers utilized the FDA-approved dosing regimen, with various methods of CrCl calculation and Scr measurement. The duration of CMV prophylaxis reported deviated frequently from the FDA-label. Studies evaluating clinical outcomes associated with different VCGV dosing and duration strategies are warranted to determine the most appropriate VGCV regimen for CMV prophylaxis and treatment in pediatric SOT recipients.

CITATION INFORMATION: Shaikh S., Panek N., Park J. A National Survey of Valganciclovir Dosing Strategies in Pediatric Solid Organ Transplant Recipients Am J Transplant. 2017;17 (suppl 3).

« Back to 2018 American Transplant Congress