Pentavalent antimonial has been the front-line drug for the treatment of Visceral Leishmaniasis (VL) for over 70 years until the discovery of antileishmanial activity in the well-known anti-fungal agent, Amphotericin B. The encapsulation of Amphotericin B in liposome was first shown to effectively cure VL in 1991 leading to a successful development of the lipid form, which is now the drug of choice for the treatment of VL. The lipid associated amphotericin B has been tested in three different formulations: colloidal dispersion amphotericin B, lipid complex amphotericin B, and liposomal amphotericin B (LAmB). The latter is available either as a single dose regimen or as a multiple dose regimen administered over a treatment period often lasting over one month.
The practical advantages offered by the single dose LAmB regimen has meant that this has been the drug of choice in the VL elimination programme in India, Bangladesh and Nepal, and is currently deployed as a 10mg/kg single dose (or in some cases as 2–5mg/kg doses) with patients followed-up at 1, 6 and 12 months post-treatment. While this drug regimen has demonstrated high efficacy, the tolerability profile hasn’t been well-understood. Antileishmanial therapies have been historically associated with a poor tolerability profile. However, there is a paucity of information regarding the expected rate of incidence of the severe adverse events and deaths following antileishmanial chemotherapies. This review was conducted to address this research gap.