Effectiveness and safety of liposomal amphotericin B for visceral leishmaniasis under routine program conditions in Bihar, India

Am J Trop Med Hyg. 2010 Aug;83(2):357-64. doi: 10.4269/ajtmh.2010.10-0156.

Abstract

We evaluated, through the prospective monitoring of 251 patients at Sadar Hospital in Bihar, India, the effectiveness and safety of 20 mg/kg body weight of liposomal amphotericin B for the treatment of visceral leishmaniasis. The treatment success rates for the intention-to-treat, per protocol, and intention-to-treat worse-case scenario analyses were 98.8%, 99.6%, and 81.3%, respectively. Nearly one-half of patients experienced mild adverse events, but only 1% developed serious but non-life-threatening lips swelling. The lost to follow-up rate was 17.5%. Our findings indicate that the 20 mg/kg body weight treatment dosage is effective and safe under routine program conditions. Given that the exorbitant cost of liposomal amphotericin B is a barrier to its widespread use, we recommend further study to monitor and evaluate a lowered dosage and a shorter treatment course.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Amphotericin B / administration & dosage
  • Amphotericin B / adverse effects*
  • Amphotericin B / therapeutic use*
  • Antiprotozoal Agents / administration & dosage
  • Antiprotozoal Agents / adverse effects*
  • Antiprotozoal Agents / therapeutic use*
  • Child
  • Child, Preschool
  • Cohort Studies
  • Female
  • Humans
  • India
  • Leishmaniasis, Visceral / drug therapy*
  • Liposomes
  • Male
  • Middle Aged
  • Young Adult

Substances

  • Antiprotozoal Agents
  • Liposomes
  • liposomal amphotericin B
  • Amphotericin B