Efficacy and safety of liposomal amphotericin B (AmBisome) for visceral leishmaniasis in endemic developing countries.
Reported are the results of a study to determine the efficacy and safety of liposomal amphotericin B (AmBisome) for treating visceral leishmaniasis (kala-azar) in several developing countries where the disease is endemic (Brazil, India, and Kenya). At each study site, sequential cohorts of 10 patients each were treated with AmBisome at a dose of 2 mg.kg-1.day-1 (2 MKD). The first cohort received regimen 1:2 MKD on days 1-6 and day 10 (total dose: 14 mg/kg). If the efficacy with this regimen was satisfactory, a second cohort received regimen 2:2 MKD on days 1-4 and 10 (total dose: 10 mg/kg); and a third cohort received regimen 3:2 MKD on days 1, 5, and 10 (total dose: 6 mg/kg). In India, regimens 1, 2, and 3 (which were studied concurrently) each cured 100% of 10 patients. In Kenya, regimen 1 cured all 10 patients, regimen 2 cured 90% of 10 patients, but regimen 3 cured only 20% of 5 patients. In Brazil, regimen 1 was only partially curative: 5 of 13 patients (62%). Therefore, 15 patients were administered regimen 4 (2 MKD for 10 consecutive days; total dose, 20 mg/kg) and 13 patients were cured (83%). These results suggest that for the treatment of kala-azar the following doses of AmBisome should be administered: in India and Kenya, 2 mg/kg on days 1-4 and day 10; and in Brazil, 2 mg/kg on days 1-10.
Berman
J D
JD
Biology Department, Walter Reed Army Institute of Research, Washington, DC, USA.
Badaro
R
R
Thakur
C P
CP
Wasunna
K M
KM
Behbehani
K
K
Davidson
R
R
Kuzoe
F
F
Pang
L
L
Weerasuriya
K
K
Bryceson
A D
AD
D000293:Adolescent; D000328:Adult; D000666:Amphotericin B / Q000627:therapeutic use*; D000981:Antiprotozoal Agents / Q000627:therapeutic use*; D001938:Brazil; D002648:Child; D003906:Developing Countries; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D019353:Endemic Diseases; D006801:Humans; D007194:India; D007630:Kenya; D007898:Leishmaniasis, Visceral / Q000188:drug therapy* / Q000453:epidemiology; D016896:Treatment Outcome
D000981:Antiprotozoal Agents; C068538:liposomal amphotericin B; D000666:Amphotericin B