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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.
Varela-Fascinetto, G; Benchimol, C; Reyes-Acevedo, R; Genevray, M; Bradley, D; Ives, J; Silva, H T.
Afiliação
  • Varela-Fascinetto G; Department of Transplantation, Hospital Infantil de México Federico Gómez, Mexico City, Mexico.
  • Benchimol C; Department of Pediatrics, Mount Sinai Medical Center, New York, NY, USA.
  • Reyes-Acevedo R; Department of Transplantation, Hospital de Especialidades Miguel Hidalgo, Aguascalientes, Mexico.
  • Genevray M; PDS Safety Risk Management, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
  • Bradley D; PD Clinical Science, Roche Products Ltd, Welwyn Garden City, UK.
  • Ives J; PD Clinical Science, Roche Products Ltd, Welwyn Garden City, UK.
  • Silva HT; Nephrology Division, Hospital do Rim, Universidade Federal de São Paulo, São Paulo, Brazil.
Pediatr Transplant ; 21(1)2017 Feb.
Article em En | MEDLINE | ID: mdl-27753183
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Antivirais / Comprimidos com Revestimento Entérico / Ganciclovir / Transplante de Rim / Infecções por Citomegalovirus Tipo de estudo: Clinical_trials / Etiology_studies / Risk_factors_studies Limite: Adolescent / Child / Child, preschool / Female / Humans / Infant / Male Idioma: En Revista: Pediatr Transplant Assunto da revista: PEDIATRIA / TRANSPLANTE Ano de publicação: 2017 Tipo de documento: Article País de afiliação: México País de publicação: Dinamarca

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Antivirais / Comprimidos com Revestimento Entérico / Ganciclovir / Transplante de Rim / Infecções por Citomegalovirus Tipo de estudo: Clinical_trials / Etiology_studies / Risk_factors_studies Limite: Adolescent / Child / Child, preschool / Female / Humans / Infant / Male Idioma: En Revista: Pediatr Transplant Assunto da revista: PEDIATRIA / TRANSPLANTE Ano de publicação: 2017 Tipo de documento: Article País de afiliação: México País de publicação: Dinamarca