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

[mmukhtar]

Dear Colleagues,
The outcome of the ambisome trial is very promising, and should be carefully evaluated. the wideluse of ambisome as first line treatment for VL should be addressed cautiously specially in differen geographical regions. Although Ambisome is raley used in Sduan we already have two resistant leishmania isolates and reports of immediate hypersenstivity reactions to Ambisome were recorded in two patients treated in our hospitals. It is very ealry to talk about changing policy and treatment protocols. 
Thanks
Maowia




Professor Maowia M. Mukhtar
Institute of Endemic Diseases
University of Khartoum
P.O. Box 11463, Khartoum\, Sudan
Te: +249912234268
Fax: +249183779712
________________________________________
From: leish-l-bounces at lineu.icb.usp.br [leish-l-bounces at lineu.icb.usp.br] On Behalf Of Manica Balasegaram [mbalasegaram at dndi.org]
Sent: 12 February 2010 13:53
To: jeffrey shaw; Leish-L
Subject: Re: [Leish-l] FW:  Single-Dose Therapy for Visceral Leishmaniasis

Dear all,
This is just to let you know that the Drugs for Neglected Diseases initiative and Leishmania East Africa Platform (DNDi and LEAP) is conducting a trial on the minimum effective doses of Ambisome in Ethiopia and Sudan. Information on this trial is available on clinical trials.gov. Recruitment is currently ongoing in both countries.

It would be advisable in my opinion to await the outcomes of this clinical trial before policies are made. From previous phase II trials, the efficacy of AmBisome against VL varies according to geographical region so one should be cautious in extrapolating Indian data from one trial site.

Many regards
Dr Manica Balasegaram
Project Manager
Drugs for Neglected Diseases initiative
email: mbalasegaram at dndi.org<mailto:mbalasegaram at dndi.org>
Tel: +41 22 906 9237
Mobile: +41 79 276 2283
15 Chemin Louis Dunant
1202 Geneva
Switzerland
www.dndi.org<http://www.dndi.org/>


________________________________
From: leish-l-bounces at lineu.icb.usp.br [mailto:leish-l-bounces at lineu.icb.usp.br] On Behalf Of jeffrey shaw
Sent: Friday, February 12, 2010 11:38 AM
To: Leish-L
Subject: [Leish-l] FW: Single-Dose Therapy for Visceral Leishmaniasis


________________________________
Date: Thu, 11 Feb 2010 22:58:51 -0800
From: s_bashaye at yahoo.com
Subject: Re: [Leish-l] Single-Dose Therapy for Visceral Leishmaniasis
To: jayusp at hotmail.com; leish-l at lineu.icb.usp.br
Dear all,

It is good news to Developing countries like Ethiopia. We opt for short course therapies in that it minimizes time for admission which is related again to many interrelated costs, Problems related to treatment cost should of course be. Is there a need of conducting related trial in Africa including Ethiopia?
Seife Bashaye,
RTI /PMI, Ethiopia

________________________________
From: jeffrey shaw <jayusp at hotmail.com>
To: Leish-L <leish-l at lineu.icb.usp.br>
Sent: Thu, February 11, 2010 8:07:55 AM
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<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.