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- Title
Amphotericin B Colloidal Dispersion for the Treatment of Indian Visceral Leishmaniasis.
- Authors
Sundar, Shyam; Mehta, Himanshu; Chhabra, Amit; Singh, Vikram; Chauhan, Vineet; Desjeux, Philippe; Rai, Madhukar
- Abstract
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.
- Subjects
LEISHMANIASIS; AMPHOTERICIN B; ANTIMONY; POLYENE antibiotics; DISPERSION (Chemistry); IONOPHORES; COLLOIDAL crystals
- Publication
Clinical Infectious Diseases, 2006, Vol 42, Issue 5, p608
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1086/500138