Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients with Invasive Aspergillosis, Invasive Candidiasis, or Esophageal Candidiasis.
2017
Data on safety and efficacy of voriconazole for invasive
aspergillosis (IA) and invasive candidiasis/esophageal
candidiasis (IC/EC) in pediatric patients are limited. Methods:
Patients aged 2-<18 years with IA and IC/EC were enrolled in 2
prospective open-label, non-comparative studies of
voriconazole. Patients followed dosing regimens based on age,
weight and indication, with adjustments permitted. Treatment
duration was 6-12 weeks for IA patients, 14 days after last
positive Candida culture for IC patients and 7 days after
signs/symptoms resolution for EC patients. Primary analysis for
both the studies was safety and tolerability of voriconazole.
Secondary end points included global response success at week 6
and end of treatment (EOT), all-causality mortality and time to
death. Voriconazole exposure-response relationship was
explored. Results: Of 53 voriconazole-treated pediatric
patients (31 IA; 22 IC/EC), 14 had proven/probable IA, 7 had
confirmed IC and 10 had confirmed EC. Treatment-related hepatic
and visual adverse events, respectively, were reported in 22.6%
and 16.1% of IA patients, and 22.7% and 27.3% of IC/EC
patients. All-causality mortality in IA patients was 14.3% at
week 6; no deaths were attributed to voriconazole. No deaths
were reported for IC/EC patients. Global response success rate
was 64.3% (week 6 and EOT) in IA patients and 76.5% (EOT) in
IC/EC patients. There was no association between voriconazole
exposure and efficacy; however, a slight positive association
between voriconazole exposure and hepatic adverse events was
established. Conclusions: Safety and efficacy outcomes in
pediatric patients with IA and IC/EC were consistent with
previous findings in adult patients.
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