title: Amphotericin B treatment for Indian visceral leishmaniasis: conventional versus lipid formulations.
abstract: In Bihar, India, where visceral leishmaniasis is hyperendemic, amphotericin B deoxycholate is now first-line parenteral treatment. To test the efficacy of amphotericin B deoxycholate versus that of its lipid formulations, Indian patients were randomized to receive treatment with amphotericin B deoxycholate (1 mg/kg on alternate days for 30 days; n=51), liposomal amphotericin B (2 mg/kg per day for 5 days; n=51), or amphotericin B lipid complex (2 mg/kg per day for 5 days; n=51). Infusion-associated reactions were frequent and persistent in subjects treated with amphotericin B deoxycholate. The illness of 3 patients failed to respond to treatment, and 5 patients experienced relapse. Final cure rates were similar. Estimated total treatment costs for a 25-kg patient-417 dollars for amphotericin B deoxycholate, 872 dollars for liposomal amphotericin B, and 947 dollars for amphotericin B lipid complex-differed as a result of drug cost. Substantial reductions (approximately 60%) in the price of liposomal amphotericin B and amphotericin B lipid complex would make treatment costs comparable to that of amphotericin B deoxycholate, permitting administration of short-course regimens in India.
authors.affiliation: Kala-Azar Medical Research Center, Department of Medicine, Banaras Hindu University, Institute of Medical Sciences, Varanasi, India. shyam_vns@satyam.net.in
authors.forename: Shyam
authors.initials: S
authors.lastname: Sundar
authors.forename: Himanshu
authors.initials: H
authors.lastname: Mehta
authors.forename: A V
authors.initials: AV
authors.lastname: Suresh
authors.forename: Shri P
authors.initials: SP
authors.lastname: Singh
authors.forename: Madhukar
authors.initials: M
authors.lastname: Rai
authors.forename: Henry W
authors.initials: HW
authors.lastname: Murray
mesh_terms: D000293:Adolescent; D000328:Adult; D000666:Amphotericin B / Q000009:adverse effects / Q000627:therapeutic use*; D000818:Animals; D000981:Antiprotozoal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003840:Deoxycholic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D016527:Drug Costs; D005260:Female; D017721:Hospital Costs; D006801:Humans; D007194:India / Q000453:epidemiology; D007223:Infant; D007898:Leishmaniasis, Visceral / Q000188:drug therapy* / Q000453:epidemiology; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D010713:Phosphatidylcholines / Q000009:adverse effects / Q000627:therapeutic use*; D010715:Phosphatidylglycerols / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000981:Antiprotozoal Agents; D004338:Drug Combinations; D008081:Liposomes; D010713:Phosphatidylcholines; D010715:Phosphatidylglycerols; C068538:liposomal amphotericin B; D003840:Deoxycholic Acid; D000666:Amphotericin B; C059765:amphotericin B, deoxycholate drug combination