Efficacy and Safety of Voriconazole (VORI) in the Treatment of Invasive Fungal Infection in Children.
Aim: To describe the efficacy and safety of VORI in children treated within the compassionate program. Methods: All children who received VORI on a compassionate basis due to failure and/or intolerance to previous antifungals prior to June 22, 1999, were analysed; patients [pts] with definite or probable invasive fungal infection were assessed for efficacy. VORI dosing: loading doses 6 mg/kg/q12h iv on Day 1, then 4 mg/kg/q12h iv onwards. If feasible iv VORI was switched to oral (100 mg/bid or 200 mg/bid for <40 kg or ?40 kg pts, respectively). Outcome was assessed by investigators at End of Therapy [EOT] or at the last visit, as successful (complete or partial response) or not, based on standard criteria. Results: 72 children (1 to 15 y, median 7 y) received VORI; 63 had probable or definite fungal infections. 60/63 pts were immunocompromised; haematological malignancies (27) and chronic granulomatous disease [CGD] (14) were the most frequent underlying conditions. Haematological risk factors were present in 29 pts. There were 44 pts with aspergillosis, 8 with scedosporiosis, 5 with invasive candidiasis, 6 with other fungal infections. The median duration of VORI therapy was 93 days. At EOT/last visit 27 pts (44%) had a complete (11) or partial (16) response and 36 pts had discontinued (stable-5; intolerance-6, failure-25). The success rate was highest in patients with CGD (57%) and lowest in patients with haematological malignancies (25%). The frequency of serious adverse events (SAEs) in children was similar to that in the adult population (1.36 vs 1.15 per pt, respectively). Two pts experienced treatment related SAEs (ulcerated lips with rash; increased liver function tests [LFT]). VORI related AEs included skin rash (8), raised LFTs (5), blurred vision (2), vomiting (1), hypokalemia (1), and labile blood pressure (1). Conclusion: VORI appears to be reasonably tolerated by children and may thus be an option for the treatment of invasive fungal infection in paediatrics.
Full conference title:
Abstracts of the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy