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Astellas Pharma Inc.

Focus on Fungal Infections Newsletter
Focus on Fungal Infections Newsletter

Update on Antifungal Therapies


During the Focus on Fungal Infections meeting, Dr. Kieren Marr presented and led a discussion on the results of the voriconazole vs liposomal amphotericin B trial recently published in The New England Journal of Medicine (2002). The study objectives were to evaluate the efficacy of voriconazole compared to liposomal amphotericin B in empirical treatment of invasive fungal infections (IFI), as well as the safety and tolerability of voriconazole. The results showed that voriconazole did not meet the predetermined criteria for noninferiority, but significantly reduced the frequency of breakthrough fungal infections compared to a 3 mg/kg/day dose of liposomal amphotericin B.

Following the presentation, it was questioned whether the 3 mg/kg/day dose of liposomal amphotericin B may have been too low. A dose of 5 mg/kg/day or higher may have significantly impacted outcomes. In Dr. Marr's opinion, the reported incidence of breakthrough fungal infections could have been affected by whether patients received prophylactic therapy with another agent before enrollment in the study. Further, at the FDA Antiviral Drugs Advisory Committee meeting, a sensitivity analysis conducted by the FDA that included deaths as failures showed no difference between the 2 drugs in the incidence of breakthrough fungal infections (9.2% in both arms). The other 4 components of the composite endpoint showed a numerical advantage favoring AmBisome.

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