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India bears the burden of about half of global visceral leishmaniasis (VL) cases with emerging problems of stibanate resistance. Liposomal preparations have improved treatment outcome through shorter duration of therapy and lower toxicity compared with conventional amphotericin B. We report the efficacy of two short-course regimens of an Indian preparation of liposomal amphotericin B (Fungisome™) for VL caused by Leishmania donovani in India. An open-label, randomized, single-center comparative study was undertaken from 2008 to 2011, involving 120 treatment naive non–human immunodeficiency virus VL patients randomly allocated to two groups. Fungisome™ was given, in groups A (N = 60), 5 mg/kg daily for 2 days and B (N = 60), 7.5 mg/kg daily for 2 days, as intravenous infusion. Initial cure rate was 100% in both the groups after 1 month posttreatment. At 6 months after completion of treatment, definitive cure rate was group A 90% (54/60, 95% confidence interval (CI): 80.55–95.72%); group B: 100% (95% CI: 95.92–100%); (P = 0.027). No serious adverse events occurred in either group. The short-course, 2-day regimen of 15 mg/kg Fungisome™ infusion is easy to administer, effective, and safe for treatment of VL caused by L. donovani in India.
Financial support: Fungisome™ was supplied free of cost by Lifecare Innovations, India, the manufacturer of the product. No monetary funding was involved regarding any part of this work or manuscript preparation.
Authors' addresses: Rama P. Goswami, Sukhen Das, and Mehebubar Rahman, Department of Tropical Medicine, Calcutta School of Tropical Medicine, West Bengal, India, E-mails: firstname.lastname@example.org, email@example.com, and firstname.lastname@example.org. Rudra P. Goswami, Department of Rheumatology, Institution of Post Graduate Medical Education and Research, West Bengal, India, E-mail: email@example.com. Aditya Satpati, Department of Medicine, ESI Hospital, Joka, West Bengal, India, E-mail: firstname.lastname@example.org.