[Leish-l] Single-Dose Therapy for Visceral Leishmaniasis

jeffrey shaw jayusp at hotmail.com
Thu Feb 11 11:07:55 BRST 2010


Summary 
and Comment

Single-Dose Therapy for Visceral LeishmaniasisA 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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