Gilead trial of AmBisome for invasive fungal infections provides important dosing information

By E. Janene Geiss

Philadelphia, Dec. 12 - Gilead Sciences, Inc. announced Monday that results from its clinical trial AmBiLoad, which compared a 3 mg a day treatment course of AmBisome (amphotericin B) liposome for injection versus a 10 mg a day loading regimen for the initial two weeks of treatment in immunocompromised patients with invasive aspergillosis and other life-threatening fungal infections, determined important dosing information.

In this study, the overall rate of response for the two dosing regimens at end of treatment were associated with similar efficacy and survival, 50% in the standard dosing group versus 46% in the high loading-dose group.

But, the 3 mg a day dose was better tolerated in the study, according to a company news release.

"This study provided important insights into the optimum dose and dosing regimen of AmBisome for established invasive fungal infections - data that have been lacking thus far," said Oliver A. Cornely, a principal investigator.

"The results from this study clearly confirm the efficacy of the standard dosing regimen, which was associated with a favorable response in half of patients and a 72% survival rate 12 weeks after the end of treatment. These findings are on par with response and survival rates reported in similar studies of other licensed antifungal agents. This is especially impressive, since patients in AmBiLoad had a high burden of risk factors for profoundly impaired immune function," Cornely said.

Product labeling for AmBisome varies in each of the countries in which it is marketed. AmBisome is indicated in most countries for the treatment of confirmed invasive fungal infections such as aspergillosis, which primarily affects patients with impaired immune function and can be fatal.

The currently approved doses of AmBisome for the treatment of confirmed invasive fungal infections vary from 1 to 5 mg a day. Preclinical data have suggested that increasing doses of AmBisome may be associated with improved antifungal efficacy, and limited studies in human subjects suggested that doses of 10 mg a day could be administered without a significant increase in adverse events.

Results of the AmBiLoad clinical trial were presented Monday at the American Society of Hematology annual meeting in Atlanta.

Gilead Sciences is a Foster City, Calif., biopharmaceutical company that develops and commercializes innovative therapeutics in areas of unmet medical need.

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