Amphotericin B treatment for Indian visceral leishmaniasis: conventional versus lipid formulations

Clin Infect Dis. 2004 Feb 1;38(3):377-83. doi: 10.1086/380971. Epub 2004 Jan 13.

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Amphotericin B / adverse effects
  • Amphotericin B / therapeutic use*
  • Animals
  • Antiprotozoal Agents / adverse effects
  • Antiprotozoal Agents / therapeutic use*
  • Child
  • Child, Preschool
  • Deoxycholic Acid / adverse effects
  • Deoxycholic Acid / therapeutic use*
  • Drug Combinations
  • Drug Costs
  • Female
  • Hospital Costs
  • Humans
  • India / epidemiology
  • Infant
  • Leishmaniasis, Visceral / drug therapy*
  • Leishmaniasis, Visceral / epidemiology
  • Liposomes
  • Male
  • Middle Aged
  • Phosphatidylcholines / adverse effects
  • Phosphatidylcholines / therapeutic use*
  • Phosphatidylglycerols / adverse effects
  • Phosphatidylglycerols / therapeutic use*
  • Treatment Outcome

Substances

  • Antiprotozoal Agents
  • Drug Combinations
  • Liposomes
  • Phosphatidylcholines
  • Phosphatidylglycerols
  • liposomal amphotericin B
  • Deoxycholic Acid
  • Amphotericin B
  • amphotericin B, deoxycholate drug combination