Effectiveness and safety of AmBisome® (liposomal amphotericin B) in combination with voriconazole in patients with invasive fungal infections. A multicentre retrospective study (RAVES study)
Abstract number: P1034
Askari E., García P., Jarque I., Nicolás S., Blanco C., Caballero M., Cáceres J., García E., Gómez V., Canales M.
Objectives: To study the efficacy and safety of the combination of AmBisome® and voriconazole in patients with invasive fungal infections (IFIs).
Methods: Retrospective, multicentre, data collection of patients treated with a combination of AmBisome® and voriconazole in Spanish hospitals. Data were included from patients treated for at least six days from October 2003 to November 2006. Infections were classified as proven, probable and possible according to the EORTC criteria. The primary endpoint was one month survival after drug study discontinuation.
Results: Thirteen patients were included in the study, eight were oncohematologic (five neutropenic) and five were intensive care patients. Four hematologic patients presented with a proven IFI (Aspergillus flavus, Fusarium spp., Scedosporium spp., and Candida spp.+unidentified mould), two with a probable IFI (Fusarium oxysporum, and Scesdosporium spp.) and two with a possible IFI (in one case cerebral toxoplasmosis was diagnosed in the necropsy study). Four intensive care patients presented with a proven infection (Candidaemia) and one patient showed a probable IFI (Aspergillus flavus and Aspergillus fumigatus). Doses of AmBisome® ranged from 2 to 5.5 mg/kg/day with a minimum treatment duration of six days and a maximum of 50 days. Two patients died within one month after study drug discontinuation: one patient after 48 hours and one after 30 days. Neither death was related to the fungal infection (one case cerebral toxoplasmosis and in the other one peritonitis). After discontinuation of study drug, a complete response was observed in nine patients, a partial response in three patients, and the patient with cerebral toxoplasmosis remained stable. Six patients experienced alterations in hepatic function, and in one of them voriconazole treatment was discontinued due to hepatotoxicity. No clinically relevant increases in serum creatinine levels (i.e. serum creatinine twice baseline level) were observed.
Conclusion: Although this is a small collection of cases, the efficacy results suggest no clinical antagonism of AmBisome® plus voriconazole in combination. Safety results suggest that this combination can be administered to high risk patients.
|Session name:||18th European Congress of Clinical Microbiology and Infectious Diseases|
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