Academic Journal
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
| العنوان: | 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 |
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| المؤلفون: | Varela‐Fascinetto, G., Benchimol, C., Reyes‐Acevedo, R., Genevray, M., Bradley, D., Ives, J., Silva, H. T. |
| المساهمون: | F. Hoffmann-La Roche |
| المصدر: | Pediatric Transplantation ; volume 21, issue 1 ; ISSN 1397-3142 1399-3046 |
| بيانات النشر: | Wiley |
| سنة النشر: | 2016 |
| المجموعة: | Wiley Online Library (Open Access Articles via Crossref) |
| الوصف: | 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 AE s 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 AE s during days 101‐228 vs days 1‐100. Twenty‐seven patients (48.2%) had treatment‐related AE s during valganciclovir treatment, most commonly leukopenia (21.4%), neutropenia (19.6%), anemia (7.1%), and tremor (5.4%). Treatment‐related serious AE s were reported for nine patients (16.1%) and six withdrew due to AE s. Viremia was centrally confirmed in 10 patients; there was no confirmed CMV disease. One patient tested positive for a resistance mutation ( UL 97 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1111/petr.12833 |
| الاتاحة: | http://dx.doi.org/10.1111/petr.12833 https://api.wiley.com/onlinelibrary/tdm/v1/articles/10.1111%2Fpetr.12833 https://onlinelibrary.wiley.com/doi/pdf/10.1111/petr.12833 |
| Rights: | http://onlinelibrary.wiley.com/termsAndConditions#vor |
| رقم الانضمام: | edsbas.51E25FC3 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1111/petr.12833 |
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