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Single-Dose Therapy for Visceral Leishmaniasis

A single infusion of liposomal amphotericin B was not inferior to a 15-dose regimen of amphotericin B deoxycholate.

Despite impressive cure rates for several antileishmanial agents, lengthy treatment courses limit the appeal of these therapies. In recent clinical trials, high cure rates have been seen with a 5-day course of liposomal amphotericin B. This finding, coupled with a price reduction for this antimicrobial in developing countries, prompted evaluation of even shorter courses of therapy.

In an open-label trial, 410 patients with visceral leishmaniasis, or kala-azar, were randomized to receive a single infusion of liposomal amphotericin B (10 mg/kg) or 15 alternate-day infusions of amphotericin B deoxycholate (1 mg/kg; conventional therapy). The trial was conducted in northeastern India, which is home to approximately 50% of such patients worldwide. Participants — aged 2 to 65 years — were evaluated at 30 days postenrollment for apparent cure (i.e., absence of fever, clinical improvement, reduction in spleen size, and a splenic-aspirate score of 0) and then at 6 months for cure (being healthy, with no signs or symptoms of relapse).

All 304 patients in the liposomal-therapy group and 106 (98%) of 108 in the conventional-therapy group had apparent cure at 30 days postenrollment. At 6 months, cure rates were similar between groups: 95.7% (95% confidence interval, 93.4%–97.9%) and 96.3% (95% CI, 92.6%–99.9%), respectively. No serious adverse events were reported in either group. The estimated treatment costs were higher for amphotericin B deoxycholate than for liposomal amphotericin B (US$436 vs. $162).

Comment: The availability of a new preferential price agreement for liposomal amphotericin B in developing countries was key in the decision to conduct this trial. The results are impressive and should prompt a reevaluation of current treatment strategies for kala-azar.

— Larry M. Baddour, MD

Published in Journal Watch Infectious Diseases February 10, 2010

Citation(s):

Sundar S et al. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med 2010 Feb 11; 362:504.

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• Immunology of drug effects
  RANJAN DHAR, IICB, 16 Feb 2010 8:01 AM EST
  The work which is published in the journal is very good in deed. but I have a few questions about... [more]

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