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

Dr. Abate Mulugeta amulugeta001 at gmail.com
Tue Mar 2 02:22:55 BRT 2010

I fully agree with Manica that it is better to wait the result of the trail
on progress before decision as species and host variability greatly
influence treatment outcome.


Abate Mulugeta, Dr
WHO-Ethiopia, NTD/Leish Officer

On Thu, Feb 11, 2010 at 4:07 PM, jeffrey shaw <jayusp at hotmail.com> wrote:

>  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<http://infectious-diseases.jwatch.org/misc/board_about.dtl?q=etoc_jwid#aBaddour>
> *
> *Published in* Journal Watch Infectious Diseases<http://infectious-diseases.jwatch.org/>
> *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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Abate M. Beshah (Dr.)
NPO/Leish, WHO
+251 (09) 11 401 001
amulugeta001 at gmail.com
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