Journal Article

Amphotericin B Colloidal Dispersion for the Treatment of Indian Visceral Leishmaniasis

Shyam Sundar, Himanshu Mehta, Amit Chhabra, Vikram Singh, Vineet Chauhan, Philippe Desjeux and Madhukar Rai

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 42, issue 5, pages 608-613
Published in print March 2006 | ISSN: 1058-4838
Published online March 2006 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/500138
Amphotericin B Colloidal Dispersion for the Treatment of Indian Visceral Leishmaniasis

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Background. In Bihar, India, where visceral leishmaniasis (VL) is hyperendemic and refractory to antimony, amphotericin B is the most effective option for the treatment of VL. Lipid formulations of amphotericin B are able to circumvent the toxic effect of conventional amphotericin B, and the total dose of these formulations can be administered over a short duration. However, cost is a major constraint in the use of lipid formulations of amphotericin B. Amphotericin B colloidal dispersion (ABCD), which is a less expensive lipid formulation, has not been tested for the treatment of VL in India.

Methods. In an open-label, randomized clinical trial, we evaluated the efficacy and safety of a 6-day course of ABCD administered to 3 different dose groups (total dose: 7.5 mg/kg [group A], 10 mg/kg [group B], and 15 mg/kg [group C]), each of which included a cohort of 135 patients.

Results. Although infusion-related fever and chills occurred in 56%–68% of patients in the 3 different dose groups, 401 of 405 patients completed the treatment. All 135 patients in group A completed treatment, and the final cure rate for this group was 97%. In the group that received the highest dose of ABCD (group C), severe backache, an unusual side effect, was observed in 8 patients (5.92%). Serious adverse effects led to the withdrawal of 2 patients (1.48%) each from group B and group C.

Conclusions. Although the cost of ABCD is prohibitive, the high level of efficacy associated with short-term treatment with low-dose ABCD provides another alternative for the treatment of VL, especially in regions where VL is antimony refractory.

Journal Article.  4167 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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