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 safe ty of liposomal amphotericin B (AmBisome) for treating visceral leishm aniasis (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 o n days 1-6 and day 10 (total dose: 14 mg/kg). If the efficacy with thi s regimen was satisfactory, a second cohort received regimen 2: 2 MKD on days 1-4 and day 10 (total dose: 10 mg/kg); and a third cohort rece ived regimen 3:2 MKD on days 1, 5, and 10 (total dose: 6 mg/kg). In In dia, regimens 1, 2 and 3 (which were studied concurrently) each cured 100% of 10 patients. In Kenya, regimen 1 cured all 10 patients, regime n 2 cured 90% of 10 patients, but regimen 3 cured only 20% of 5 patien ts. 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 f ollowing 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.