alexa Single-dose liposomal amphotericin B for visceral leishmaniasis in India.
Genetics & Molecular Biology

Genetics & Molecular Biology

Journal of Molecular Biomarkers & Diagnosis

Author(s): Sundar S, Chakravarty J, Agarwal D, Rai M, Murray HW

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Abstract BACKGROUND: Some 50\% of patients with visceral leishmaniasis (kala-azar) worldwide live in the Indian state of Bihar. Liposomal amphotericin B is an effective treatment when administered in short courses. We wanted to determine whether the efficacy of a single infusion of liposomal amphotericin B was inferior to conventional parenteral therapy, consisting of 15 alternate-day infusions of amphotericin B deoxycholate. METHODS: In this open-label study, we randomly assigned 412 patients in a 3:1 ratio to receive either liposomal amphotericin B (liposomal-therapy group) or amphotericin B deoxycholate (conventional-therapy group). Liposomal amphotericin B (at a dose of 10 mg per kilogram of body weight) was given once, and patients were discharged home 24 hours later. Amphotericin B deoxycholate, which was administered in 15 infusions of 1 mg per kilogram, was given every other day during a 29-day hospitalization. We determined the cure rate 6 months after treatment. RESULTS: A total of 410 patients--304 of 304 patients (100\%) in the liposomal-therapy group and 106 of 108 patients (98\%) in the conventional-therapy group--had apparent cure responses at day 30. Cure rates at 6 months were similar in the two groups: 95.7\% (95\% confidence interval [CI], 93.4 to 97.9) in the liposomal-therapy group and 96.3\% (95\% CI, 92.6 to 99.9) in the conventional-therapy group. Adverse events in the liposomal-therapy group were infusion-related fever or rigors (in 40\%) and increased anemia or thrombocytopenia (in 2\%); such events in the conventional-therapy group were fever or rigors (in 64\%), increased anemia (in 19\%), and hypokalemia (in 2\%). Nephrotoxicity or hepatotoxicity developed in no more than 1\% of patients in each group. CONCLUSIONS: A single infusion of liposomal amphotericin B was not inferior to and was less expensive than conventional therapy with amphotericin B deoxycholate. ( number, NCT00628719.) 2010 Massachusetts Medical Society This article was published in N Engl J Med and referenced in Journal of Molecular Biomarkers & Diagnosis

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