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| |  ICAAC: Ambisome As Effective And Safe As Amphotericin B For Meningitis DEERFIELD, IL. and FOSTER CITY, CA. -- September 27, 1999 -- Fujisawa Healthcare, Inc. and Gilead Sciences, Inc. today presented results from a Phase III clinical study comparing the safety and efficacy of AmBisome (liposomal amphotericin B) to conventional amphotericin B for the initial treatment of acute cryptococcal meningitis in AIDS patients. The study results indicate that AmBisome is as effective as amphotericin B, yet appears to be significantly less toxic. The results were presented for the first time by Richard J. Hamill, MD, associate professor, Departments of Medicine and Microbiology/Immunology, Baylor College of Medicine, VA Medical Center, Houston, Texas, today at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco, California. In this double-blind comparison study, a total of 267 AIDS patients received either AmBisome at 3 mg/kg (86 patients), AmBisome at 6 mg/kg (94 patients) or conventional amphotericin B at 0.7 mg/kg (87 patients) daily for 14 to 21 days as induction therapy for acute cryptococcal meningitis. Patient demographics and other baseline characteristics were comparable between groups. Mean induction treatment durations were 13.5, 14.0 and 13.3 days, respectively. AmBisome 3 mg/kg and 6 mg/kg demonstrated efficacy equivalent to conventional amphotericin B for all endpoints, including two week culture conversion (63.3 percent, 53.7 percent and 53.7 percent respectively), two week clinical response (65. percent, 75.3 percent and 65.8 percent) and two week survival (90.7 percent, 94.7 percent and 89.7 percent). AmBisome was associated with significantly fewer infusion-related reactions compared to conventional amphotericin B. Specifically, the data indicate that patients receiving either AmBisome 3 mg/kg or 6 mg/kg experienced significantly fewer chills/rigors (5.8 percent, 8.5 percent versus 48.3 percent; p=<0.001 and p=<0.001), fever (7.0 percent, 8.5 percent versus 27.6 percent; p=<0.001 and p=<0.001) and respiratory problems (0 percent, 1.1 percent versus 9.2 percent; p=0.007 and p=0.015) as compared to the patients treated with conventional amphotericin B. In addition, the incidence of nephrotoxicity as defined by a doubling of baseline serum creatinine was lower in the AmBisome groups compared with conventional amphotericin B (14.0 percent, 21.3 percent and 33.3 percent; p=0.004 and p=0.066). The incidence of liver dysfunction was similar between treatment groups. "Cryptococcal meningitis in AIDS patients is extremely serious. Your primary treatment goal is to save lives," said Dr. Hamill, lead investigator of the Phase III trial. "To have a medication with comparable efficacy to the standard of care that so substantially reduces side effects could allow physicians to help improve the quality of care for this vulnerable patient population." Based on the study results, Fujisawa submitted a Supplemental New Drug Application (sNDA) for the anti-fungal agent AmBisome to the U.S. Food and Drug Administration (FDA) on July 6, 1999, for the treatment of cryptococcal meningitis in AIDS patients. AmBisome is co-marketed in the United States by Fujisawa Healthcare, Inc. and Gilead Sciences. It is currently indicated for the treatment of confirmed infections caused by various fungal species or visceral leishmaniasis, a parasitic infection. AmBisome is the first and only amphotericin B product cleared for marketing by the U.S. FDA for empiric therapy for presumed fungal infections in patients with low white blood cell counts and who exhibit fever of unknown origin. Additionally, AmBisome is available for the treatment of systemic fungal infections in 38 countries worldwide.
Related Links: AmBisome and Gilead Sciences Inc..
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