title: Tolerability of up to 200 days of prophylaxis with valganciclovir oral solution and/or film-coated tablets in pediatric kidney transplant recipients at risk of cytomegalovirus disease.
abstract: This multicenter, open-label study evaluated the tolerability of extended prophylaxis with valganciclovir in pediatric kidney transplant recipients at risk of CMV disease. Fifty-six patients aged 4 months to 16 years received once-daily valganciclovir oral solution and/or tablets, dosed by BSA and renal function, for up to 200 days. The most common AEs on treatment were upper respiratory tract infection (33.9%), urinary tract infection (33.9%), diarrhea (32.1%), leukopenia (25.0%), neutropenia (23.2%), and headache (21.4%). There were fewer AEs during days 101-228 vs days 1-100. Twenty-seven patients (48.2%) had treatment-related AEs during valganciclovir treatment, most commonly leukopenia (21.4%), neutropenia (19.6%), anemia (7.1%), and tremor (5.4%). Treatment-related serious AEs were reported for nine patients (16.1%) and six withdrew due to AEs. Viremia was centrally confirmed in 10 patients; there was no confirmed CMV disease. One patient tested positive for a resistance mutation (UL97 L595F). Biopsy-proven acute rejection occurred in six patients (10.7%), but no graft loss or deaths occurred. In conclusion, up to 200 days of valganciclovir prophylaxis in pediatric kidney allograft recipients showed a safety profile consistent with that established in adult transplant patients.
authors.affiliation: Department of Transplantation, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.
authors.forename: G
authors.initials: G
authors.lastname: Varela-Fascinetto
authors.affiliation: Department of Pediatrics, Mount Sinai Medical Center, New York, NY, USA.
authors.forename: C
authors.initials: C
authors.lastname: Benchimol
authors.affiliation: Department of Transplantation, Hospital de Especialidades Miguel Hidalgo, Aguascalientes, Mexico.
authors.forename: R
authors.initials: R
authors.lastname: Reyes-Acevedo
authors.affiliation: PDS Safety Risk Management, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Genevray
authors.affiliation: PD Clinical Science, Roche Products Ltd, Welwyn Garden City, UK.
authors.forename: D
authors.initials: D
authors.lastname: Bradley
authors.affiliation: PD Clinical Science, Roche Products Ltd, Welwyn Garden City, UK.
authors.forename: J
authors.initials: J
authors.lastname: Ives
authors.affiliation: Nephrology Division, Hospital do Rim, Universidade Federal de São Paulo, São Paulo, Brazil.
authors.forename: H T
authors.initials: HT
authors.lastname: Silva
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000998:Antiviral Agents / Q000008:administration & dosage*; D001706:Biopsy; D002648:Child; D002675:Child, Preschool; D003586:Cytomegalovirus Infections / Q000517:prevention & control*; D004334:Drug Administration Schedule; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007223:Infant; D016030:Kidney Transplantation / Q000379:methods*; D008297:Male; D009154:Mutation; D013608:Tablets, Enteric-Coated / Q000008:administration & dosage*; D066027:Transplant Recipients; D016896:Treatment Outcome; D000077562:Valganciclovir
chemical_list: D000998:Antiviral Agents; D013608:Tablets, Enteric-Coated; D000077562:Valganciclovir; D015774:Ganciclovir
keywords: cytomegalovirus; extended prophylaxis; safety; valganciclovir