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Combination Therapy Against Indian Visceral Leishmaniasis with Liposomal Amphotericin B (FungisomeTM) and Short-Course Miltefosine in Comparison to Miltefosine Monotherapy.
Am J Trop Med Hyg. 2020 07; 103(1):308-314.AJ

Abstract

Visceral leishmaniasis (VL) is endemic in Asia, East and North Africa, South America, and Southern Europe, and is a major public health problem in the Indian subcontinent. Miltefosine received approval in 2002 to treat VL in India, and the Indian National Vector Borne Disease Control Programme later adopted a single dose (10 mg/kg) of liposomal amphotericin B. We report results of a randomized trial comparing the efficacy of combination therapy with an Indian preparation of liposomal amphotericin B (single dose of 7.5 mg/kg) and short-course miltefosine (2.5 mg/kg/day for 14 days; n = 66) in comparison to miltefosine monotherapy (2.5 mg/kg/day for 28 days; n = 78). Nine patients in the miltefosine group and three in the combination therapy group had to discontinue therapy because of serious adverse events. At the end of the therapy, the clinical and parasitological cure rate was 100% in both groups. By per-protocol analysis, by 6 months after completion of treatment, 12 of 69 patients in the miltefosine monotherapy arm (17.4%, 95% CI: 10.24-28%) and none in the combination therapy arm had relapse. Over 5 years of follow-up, 10 patients in the miltefosine monotherapy arm (all within 0.5-2 years after completing therapy) and none in the combination therapy arm experienced post-kala-azar dermal leishmaniasis. Combination therapy offered benefits over miltefosine monotherapy for VL in India.

Authors+Show Affiliations

Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.Department of Tropical Medicine, School of Tropical Medicine, Kolkata, India.Department of Clinical and Experimental Pharmacology, School of Tropical Medicine, Kolkata, India.Department of Rheumatology, All India Institute of Medical Sciences, New Delhi, India.

Pub Type(s)

Comparative Study
Equivalence Trial
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

32394874

Citation

Goswami, Rama Prosad, et al. "Combination Therapy Against Indian Visceral Leishmaniasis With Liposomal Amphotericin B (FungisomeTM) and Short-Course Miltefosine in Comparison to Miltefosine Monotherapy." The American Journal of Tropical Medicine and Hygiene, vol. 103, no. 1, 2020, pp. 308-314.
Goswami RP, Rahman M, Das S, et al. Combination Therapy Against Indian Visceral Leishmaniasis with Liposomal Amphotericin B (FungisomeTM) and Short-Course Miltefosine in Comparison to Miltefosine Monotherapy. Am J Trop Med Hyg. 2020;103(1):308-314.
Goswami, R. P., Rahman, M., Das, S., Tripathi, S. K., & Goswami, R. P. (2020). Combination Therapy Against Indian Visceral Leishmaniasis with Liposomal Amphotericin B (FungisomeTM) and Short-Course Miltefosine in Comparison to Miltefosine Monotherapy. The American Journal of Tropical Medicine and Hygiene, 103(1), 308-314. https://doi.org/10.4269/ajtmh.19-0931
Goswami RP, et al. Combination Therapy Against Indian Visceral Leishmaniasis With Liposomal Amphotericin B (FungisomeTM) and Short-Course Miltefosine in Comparison to Miltefosine Monotherapy. Am J Trop Med Hyg. 2020;103(1):308-314. PubMed PMID: 32394874.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Combination Therapy Against Indian Visceral Leishmaniasis with Liposomal Amphotericin B (FungisomeTM) and Short-Course Miltefosine in Comparison to Miltefosine Monotherapy. AU - Goswami,Rama Prosad, AU - Rahman,Mehebubar, AU - Das,Sukhen, AU - Tripathi,Santanu Kumar, AU - Goswami,Rudra Prosad, Y1 - 2020/05/07/ PY - 2020/5/13/pubmed PY - 2020/9/1/medline PY - 2020/5/13/entrez SP - 308 EP - 314 JF - The American journal of tropical medicine and hygiene JO - Am J Trop Med Hyg VL - 103 IS - 1 N2 - Visceral leishmaniasis (VL) is endemic in Asia, East and North Africa, South America, and Southern Europe, and is a major public health problem in the Indian subcontinent. Miltefosine received approval in 2002 to treat VL in India, and the Indian National Vector Borne Disease Control Programme later adopted a single dose (10 mg/kg) of liposomal amphotericin B. We report results of a randomized trial comparing the efficacy of combination therapy with an Indian preparation of liposomal amphotericin B (single dose of 7.5 mg/kg) and short-course miltefosine (2.5 mg/kg/day for 14 days; n = 66) in comparison to miltefosine monotherapy (2.5 mg/kg/day for 28 days; n = 78). Nine patients in the miltefosine group and three in the combination therapy group had to discontinue therapy because of serious adverse events. At the end of the therapy, the clinical and parasitological cure rate was 100% in both groups. By per-protocol analysis, by 6 months after completion of treatment, 12 of 69 patients in the miltefosine monotherapy arm (17.4%, 95% CI: 10.24-28%) and none in the combination therapy arm had relapse. Over 5 years of follow-up, 10 patients in the miltefosine monotherapy arm (all within 0.5-2 years after completing therapy) and none in the combination therapy arm experienced post-kala-azar dermal leishmaniasis. Combination therapy offered benefits over miltefosine monotherapy for VL in India. SN - 1476-1645 UR - https://www.unboundmedicine.com/medline/citation/32394874/Combination_Therapy_Against_Indian_Visceral_Leishmaniasis_with_Liposomal_Amphotericin_B__FungisomeTM__and_Short_Course_Miltefosine_in_Comparison_to_Miltefosine_Monotherapy_ L2 - https://ajtmh.org/doi/10.4269/ajtmh.19-0931 DB - PRIME DP - Unbound Medicine ER -