Short-Course Treatment Regimen of Indian Visceral Leishmaniasis with an Indian Liposomal Amphotericin B Preparation (Fungisome™)

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 effi...

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Bibliographic Details
Published in:The American journal of tropical medicine and hygiene 2016-01, Vol.94 (1), p.93-98
Main Authors: Goswami, Rama P, Goswami, Rudra P, Das, Sukhen, Satpati, Aditya, Rahman, Mehebubar
Format: Article
Language:English
Subjects:
Adolescent
Adult
Amphotericin B - administration & dosage
Amphotericin B - therapeutic use
Antiprotozoal Agents - administration & dosage
Antiprotozoal Agents - therapeutic use
Child
Child, Preschool
Drug Administration Schedule
Female
Humans
India - epidemiology
Leishmania donovani
Leishmaniasis, Visceral - drug therapy
Leishmaniasis, Visceral - epidemiology
Male
Young Adult
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Summary: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.
ISSN:0002-9637
1476-1645
DOI:10.4269/ajtmh.14-0657