Treatment of visceral leishmaniasis: anomalous pricing and distribution of AmBisome and emergence of an indigenous liposomal amphotericin B, FUNGISOME

Abstract

Visceral leishmaniasis (VL) is one of the severest forms of parasite borne diseases worldwide with a mortality rate second only to malaria. Treatment of VL patients with currently available chemotherapeutic agents poses problems of large scale failure, toxicity, prolonged hospitalization time, high treatment cost and drug resistance. However, most of these problems can be overcome by the use of liposomal formulations of Amphotericin B (L-AmB). Of the two L-AmBs currently available in Indian market, AmBisome is imported and FUNGISOME is indigenous. Initially AmBisome remained exorbitantly costly and therefore inaccessible to most of the VL patients. However, with the launch of FUNGISOME in India, Gilead in agreement with WHO started a donation program of AmBisome in developing countries through a slashed price of US $18 per vial. The price reduction is, however, restricted to clinical trials thus eluding majority of the VL patients. In fact, India was not included in this program and AmBisome was sold in Indian market at prices higher than the WHO proposed price of US $18 per vial. FUNGISOME, on the other hand, produced consistently good results against VL both clinically and experimentally. In the context of unavailability and price anomaly of AmBisome, successful emergence of FUNGISOME could mark it as the major L-AmB against VL.