Journal Article

Amphotericin B Treatment for Indian Visceral Leishmaniasis: Response to 15 Daily versus Alternate-Day Infusions

Shyam Sundar, J. Chakravarty, V. K. Rai, N. Agrawal, S. P. Singh, V. Chauhan and Henry W. Murray

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 45, issue 5, pages 556-561
Published in print September 2007 | ISSN: 1058-4838
Published online September 2007 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/520665
Amphotericin B Treatment for Indian Visceral Leishmaniasis: Response to 15 Daily versus Alternate-Day Infusions

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Background. For patients with Indian visceral leishmaniasis, amphotericin B deoxycholate is usually given as 15 alternate-day infusions of 1 mg/kg over 30 days (total dose, 15 mg/kg); daily treatment with 1 mg/kg for 20 days (total dose, 20 mg/kg) is also used. This study was done to address the unsettled therapeutic questions of administration schedule (alternate-day vs. daily administration) and dose (1 vs. 0.75 mg/kg) and to determine whether the duration of amphotericin B treatment in Bihar, India, can be shortened to 15 days.

Methods. To compare alternate-day versus daily administration and 1-mg/kg versus 0.75-mg/kg doses and to determine whether the duration of treatment could be abbreviated, Indian subjects randomly received 15 infusions of 1 mg/kg (group A; 245 patients) or 0.75 mg/kg (group B; 244 patients) on alternate days or 1 mg/kg (group C; 500 patients) or 0.75 mg/kg (group D; 496 patients) daily. Noninferiority testing compared 6-month cure rates using a 5% margin.

Results. Overall, 1439 of the 1485 subjects completed treatment and responded. Treatment interruptions (nephrotoxicity) but not infusion-associated reactions or study removals were more common with daily administration. Final cure rates at 6 months were similar: group A, 234 patients (96%; 95% confidence interval [CI], 92%–98%); group B, 225 patients (92%; 95% CI, 88%–95%); group C, 483 patients (97%; 95% CI, 95%–98%); and group D, 476 patients (96%; 95% CI, 94%–97%; P > .05).

Conclusions. Provided that the serum creatinine level is repeated once, daily treatment with amphotericin B, 0.75 mg/kg for 15 days (total dose, 11.25 mg/kg), is efficient and effective for visceral leishmaniasis in India.

Journal Article.  3189 words.  Illustrated.

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

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