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

amudawi musa amudawi at hotmail.com
Fri Feb 12 18:57:09 BRST 2010


Dear all,

 

The experience from East Africa in particular from Sudan made it clear that geographical variation of the VL is a leading factor for not to extrapolate results from region to anothor for example paromomycin development for VL (in press). Ambisome at a dose of 3 mg/kg/day for 10 days for Sudanese VL and 2.5 mg/kg/day for 20 days for Sudanese PKDL is highly safe and efficacious. It is too early to tell about Ambisome single dose in East Africa both in terms of safety and efficacy, studies are ongoing.  

 

regards

 

A M Musa


From: jayusp at hotmail.com
To: leish-l at lineu.icb.usp.br
Date: Thu, 11 Feb 2010 13:07:55 +0000
Subject: [Leish-l] Single-Dose Therapy for Visceral Leishmaniasis




Summary and Comment
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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