Single-Dose Indigenous Liposomal Amphotericin B in the Treatment of Indian Visceral Leishmaniasis: A Phase 2 Study
Liposomal amphotericin B is an effective and safe alternative for the treatment of visceral leishmaniasis in the Indian subcontinent. In this study, we used a higher-dose regimen of an indigenously manufactured liposomal amphotericin B (FUNGISOME; L-AmBL), which was intended to improve the efficacy...
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| Published in | The American journal of tropical medicine and hygiene Vol. 92; no. 3; pp. 513 - 517 |
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| Main Authors | , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
The American Society of Tropical Medicine and Hygiene
01.03.2015
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| Abstract | Liposomal amphotericin B is an effective and safe alternative for the treatment of visceral leishmaniasis in the Indian subcontinent. In this study, we used a higher-dose regimen of an indigenously manufactured liposomal amphotericin B (FUNGISOME; L-AmBL), which was intended to improve the efficacy in terms of long-lasting cure rate. Thirty men and thirty women between 12 and 60 years old with parasitologically confirmed visceral leishmaniasis were enrolled in two cohorts of 15 patients each. Subjects in cohort I were administered one dose (10 mg/kg body weight) of L-AmBL intravenously. After the safety at this dose was confirmed in cohort I, patients were recruited in cohort II. They received one infusion of an escalated dose (15 mg/kg body weight). The safety of these two doses was evaluated over a period of 30 days, and efficacy was assessed for initial cure at day 30 and definitive cure at 6 months. FUNGISOME was found to be safe, with an initial cure rate of 100% at day 30 and a definitive cure rate of 93.3% at the 6-month follow-up in both the cohorts. |
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| AbstractList | Liposomal amphotericin B is an effective and safe alternative for the treatment of visceral leishmaniasis in the Indian subcontinent. In this study, we used a higher-dose regimen of an indigenously manufactured liposomal amphotericin B (FUNGISOME; L-AmBL), which was intended to improve the efficacy in terms of long-lasting cure rate. Thirty men and thirty women between 12 and 60 years old with parasitologically confirmed visceral leishmaniasis were enrolled in two cohorts of 15 patients each. Subjects in cohort I were administered one dose (10 mg/kg body weight) of L-AmBL intravenously. After the safety at this dose was confirmed in cohort I, patients were recruited in cohort II. They received one infusion of an escalated dose (15 mg/kg body weight). The safety of these two doses was evaluated over a period of 30 days, and efficacy was assessed for initial cure at day 30 and definitive cure at 6 months. FUNGISOME was found to be safe, with an initial cure rate of 100% at day 30 and a definitive cure rate of 93.3% at the 6-month follow-up in both the cohorts. Liposomal amphotericin B is an effective and safe alternative for the treatment of visceral leishmaniasis in the Indian subcontinent. In this study, we used a higher-dose regimen of an indigenously manufactured liposomal amphotericin B (FUNGISOME; L-AmBL), which was intended to improve the efficacy in terms of long-lasting cure rate. Thirty men and thirty women between 12 and 60 years old with parasitologically confirmed visceral leishmaniasis were enrolled in two cohorts of 15 patients each. Subjects in cohort I were administered one dose (10 mg/kg body weight) of L-AmBL intravenously. After the safety at this dose was confirmed in cohort I, patients were recruited in cohort II. They received one infusion of an escalated dose (15 mg/kg body weight). The safety of these two doses was evaluated over a period of 30 days, and efficacy was assessed for initial cure at day 30 and definitive cure at 6 months. FUNGISOME was found to be safe, with an initial cure rate of 100% at day 30 and a definitive cure rate of 93.3% at the 6-month follow-up in both the cohorts.Liposomal amphotericin B is an effective and safe alternative for the treatment of visceral leishmaniasis in the Indian subcontinent. In this study, we used a higher-dose regimen of an indigenously manufactured liposomal amphotericin B (FUNGISOME; L-AmBL), which was intended to improve the efficacy in terms of long-lasting cure rate. Thirty men and thirty women between 12 and 60 years old with parasitologically confirmed visceral leishmaniasis were enrolled in two cohorts of 15 patients each. Subjects in cohort I were administered one dose (10 mg/kg body weight) of L-AmBL intravenously. After the safety at this dose was confirmed in cohort I, patients were recruited in cohort II. They received one infusion of an escalated dose (15 mg/kg body weight). The safety of these two doses was evaluated over a period of 30 days, and efficacy was assessed for initial cure at day 30 and definitive cure at 6 months. FUNGISOME was found to be safe, with an initial cure rate of 100% at day 30 and a definitive cure rate of 93.3% at the 6-month follow-up in both the cohorts. |
| Author | Singh, Anup Chakravarty, Jaya Rai, Madhukar Sundar, Shyam |
| AuthorAffiliation | Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India |
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N Engl J Med. 2010 Feb 11;362(6):504-12 – reference: 11520836 - BMJ. 2001 Aug 25;323(7310):419-22 – reference: 20668544 - PLoS Negl Trop Dis. 2010;4(7):e764 – reference: 12135284 - Am J Trop Med Hyg. 2002 Feb;66(2):143-6 – reference: 11709329 - Antimicrob Agents Chemother. 2001 Dec;45(12):3487-96 – reference: 7778200 - Trop Doct. 1995 Apr;25(2):80-1 – reference: 15228258 - Trans R Soc Trop Med Hyg. 2003 May-Jun;97(3):350-4 – reference: 7867139 - Bull World Health Organ. 1994;72(6):931-6 |
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| SubjectTerms | Adolescent Adult Amphotericin B - administration & dosage Amphotericin B - therapeutic use Child Cohort Studies Dose-Response Relationship, Drug Drug Administration Schedule Female Humans India - epidemiology Leishmaniasis, Visceral - drug therapy Leishmaniasis, Visceral - epidemiology Male Middle Aged Young Adult |
| Title | Single-Dose Indigenous Liposomal Amphotericin B in the Treatment of Indian Visceral Leishmaniasis: A Phase 2 Study |
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