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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