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Safety and Efficacy of High-Dose Infusions of a Preformed Amphotericin B Fat Emulsion for Treatment of Indian Visceral Leishmaniasis

Amphotericin B deoxycholate is used as a first-line drug for visceral leishmaniasis (VL) in India. Its major drawbacks are prolonged hospitalization of treated patients and toxicity. An open label phase II study with pre-formed amphotericin B lipid emulsion (ABLE) was conducted to evaluate safety and efficacy of four regimens of 15 mg/kg each administered in 1–2 doses. Regimen 1 was 7.5 mg/kg/day on day 1 and day 3, and regimen 4 was a single bolus infusion of 15 mg/kg. The safety profile was excellent with mild infusion reactions seen in 38% of the patients. Definitive cure was achieved in 100% of the patients treated with regimen 4. The overall cure rate was 87% (95% confidence interval = 75–94%). In this study, ABLE was safe and had excellent efficacy when given as a bolus of 15 mg/kg. More studies with larger number of patients and higher doses are needed to establish acceptable, safe and efficacious regimen.

Received July 25, 2008. Accepted for publication December 17, 2008.

Financial support: This study was supported by Bharat Serum and Vaccines Limited (Mumbai, India).

^* Address correspondence to Shyam Sundar, Department of Medicine, Kala-azar Medical Research Center, Institute of Medical Sciences, Banaras Hindu University, 6 SK Gupta, Nagar Lanka, Varanasi 221 005, India. E-mail: drshyamsundar{at}hotmail.com

Authors’ addresses: S. Sundar, A. Singh, D. Agarwal, M. Rai, and J. Chakravarty, Kala-Azar Medical Research Center, Department of Medicine, Institute of Medical Sciences, Banaras Hindu University,

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