Amphotericin B Treatment for Indian Visceral Leishmaniasis: Conventional versus Lipid Formulations

• Published in: Clinical infectious diseases Vol. 38; no. 3; pp. 377 - 383
• Main Authors: Sundar, Shyam, Mehta, Himanshu, Suresh, A. V., Singh, Shri P., Madhukar, Rai, Murray, Henry W.
• Format: Journal Article
• Language: English
• Published: Chicago, IL The University of Chicago Press 01.02.2004; University of Chicago Press
• Subjects: Adolescent; Adult; amphotericin B; Amphotericin B - adverse effects; Amphotericin B - therapeutic use; amphotericin B deoxycholate; Animals; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antifungal agents; Antiprotozoal Agents - adverse effects; Antiprotozoal Agents - therapeutic use; Biological and medical sciences; Child; Child, Preschool; Cost estimates; Deoxycholic Acid - adverse effects; Deoxycholic Acid - therapeutic use; Diseases; Dosage; Drug Combinations; Drug Costs; Female; Fever; Hemoglobins; Hospital Costs; Human protozoal diseases; Humans; India - epidemiology; Infant; Infectious diseases; Leishmania; Leishmaniasis, Visceral - drug therapy; Leishmaniasis, Visceral - epidemiology; Leshmaniasis; Lipids; Liposomes; Major Articles; Male; Medical cures; Medical sciences; Middle Aged; Parasites; Parasitic diseases; Pharmacology. Drug treatments; Phosphatidylcholines - adverse effects; Phosphatidylcholines - therapeutic use; Phosphatidylglycerols - adverse effects; Phosphatidylglycerols - therapeutic use; Protozoal diseases; Treatment Outcome; Visceral leishmaniasis; Bihar; Asia; India; Human; Protozoal disease; Costs; Relapse; Cure; Rate; Kala azar; Lipids; Leishmaniasis; Parasitosis; Complex lipid; Infection; Antiprotozoal agent; Antibiotic; Antifungal agent; Treatment; Amphotericin B; Polyenic compound; Health economy; Dosage form; Parasiticide; Indian; Public health; Comparative study
• ISSN: 1058-4838; 1537-6591; 1537-6591
• DOI: 10.1086/380971

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 for amphotericin B deoxycholate, $872 for liposomal amphotericin B, and $947 for amphotericin B lipid complex—differed as a result of drug cost. Substantial reductions (∼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.