<table cellspacing="0" cellpadding="0" border="0" ><tr><td valign="top" style="font: inherit;"><DIV>Dear Prof Mukhtar,</DIV>
<DIV> </DIV>
<DIV>Thanks for your concern, there are some missing emails from this string with some misconception. LEAP is not advocating the single dose regimen in question for the geographical variation in response you mentioned. A multicentre LEAP/DNDi study is underway in Sudan and Ehiopia for a few months now.</DIV>
<DIV>The LRG/Sudan has been using Ambisome for both VL and PKDL with a number of publicaions since 1998. No cases of resistance were seen. We will be interested to know more about these two cases, were concomitant diseases excluded, how drug was prepared according to the manufacturer instructions, was the drug was well stored and the batch in question tested fo potency, what was the dose, was the drug given in a hospital etc. There is one report about resistance in Southern Sudan, but you know the logistis in that war-strcken zone.</DIV>
<DIV>Concerning the hypersensitivity reactions, Non was seen in hundreds of cases we treated with the WHO recommended dose. A study for CAEPA is underway at the present time to determine possible hypersensitivity reactions with a high single dose.</DIV>
<DIV> </DIV>
<DIV>Thanks again</DIV>
<DIV> </DIV>
<DIV>Best regards</DIV>
<DIV> </DIV>
<DIV>EAG Khalil,</DIV>
<DIV>The LRG/Sudan</DIV>
<DIV>LEAP/Africa<BR><BR>--- On <B>Fri, 2/12/10, mmukhtar <I><mmukhtar@tropmedicine.org></I></B> wrote:<BR></DIV>
<BLOCKQUOTE style="PADDING-LEFT: 5px; MARGIN-LEFT: 5px; BORDER-LEFT: rgb(16,16,255) 2px solid"><BR>From: mmukhtar <mmukhtar@tropmedicine.org><BR>Subject: Re: [Leish-l] FW: Single-Dose Therapy for Visceral Leishmaniasis<BR>To: "Manica Balasegaram" <mbalasegaram@dndi.org>, "jeffrey shaw" <jayusp@hotmail.com>, "Leish-L" <leish-l@lineu.icb.usp.br><BR>Received: Friday, February 12, 2010, 9:25 AM<BR><BR>
<DIV class=plainMail>Dear Colleagues,<BR>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. <BR>Thanks<BR>Maowia<BR><BR><BR><BR><BR>Professor Maowia M. Mukhtar<BR>Institute of Endemic Diseases<BR>University of Khartoum<BR>P.O. Box 11463, Khartoum\, Sudan<BR>Te: +249912234268<BR>Fax: +249183779712<BR>________________________________________<BR>From: <A href="http://ca.mc632.mail.yahoo.com/mc/compose?to=leish-l-bounces@lineu.icb.usp.br"
ymailto="mailto:leish-l-bounces@lineu.icb.usp.br">leish-l-bounces@lineu.icb.usp.br</A> [<A href="http://ca.mc632.mail.yahoo.com/mc/compose?to=leish-l-bounces@lineu.icb.usp.br" ymailto="mailto:leish-l-bounces@lineu.icb.usp.br">leish-l-bounces@lineu.icb.usp.br</A>] On Behalf Of Manica Balasegaram [<A href="http://ca.mc632.mail.yahoo.com/mc/compose?to=mbalasegaram@dndi.org" ymailto="mailto:mbalasegaram@dndi.org">mbalasegaram@dndi.org</A>]<BR>Sent: 12 February 2010 13:53<BR>To: jeffrey shaw; Leish-L<BR>Subject: Re: [Leish-l] FW: Single-Dose Therapy for Visceral Leishmaniasis<BR><BR>Dear all,<BR>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.<BR><BR>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.<BR><BR>Many regards<BR>Dr Manica Balasegaram<BR>Project Manager<BR>Drugs for Neglected Diseases initiative<BR>email: <A href="http://ca.mc632.mail.yahoo.com/mc/compose?to=mbalasegaram@dndi.org" ymailto="mailto:mbalasegaram@dndi.org">mbalasegaram@dndi.org</A><mailto:<A href="http://ca.mc632.mail.yahoo.com/mc/compose?to=mbalasegaram@dndi.org" ymailto="mailto:mbalasegaram@dndi.org">mbalasegaram@dndi.org</A>><BR>Tel: +41 22 906 9237<BR>Mobile: +41 79 276 2283<BR>15 Chemin Louis Dunant<BR>1202 Geneva<BR>Switzerland<BR>www.dndi.org<<A href="http://www.dndi.org/" target=_blank>http://www.dndi.org/</A>><BR><BR><BR>________________________________<BR>From: <A
href="http://ca.mc632.mail.yahoo.com/mc/compose?to=leish-l-bounces@lineu.icb.usp.br" ymailto="mailto:leish-l-bounces@lineu.icb.usp.br">leish-l-bounces@lineu.icb.usp.br</A> [mailto:<A href="http://ca.mc632.mail.yahoo.com/mc/compose?to=leish-l-bounces@lineu.icb.usp.br" ymailto="mailto:leish-l-bounces@lineu.icb.usp.br">leish-l-bounces@lineu.icb.usp.br</A>] On Behalf Of jeffrey shaw<BR>Sent: Friday, February 12, 2010 11:38 AM<BR>To: Leish-L<BR>Subject: [Leish-l] FW: Single-Dose Therapy for Visceral Leishmaniasis<BR><BR><BR>________________________________<BR>Date: Thu, 11 Feb 2010 22:58:51 -0800<BR>From: <A href="http://ca.mc632.mail.yahoo.com/mc/compose?to=s_bashaye@yahoo.com" ymailto="mailto:s_bashaye@yahoo.com">s_bashaye@yahoo.com</A><BR>Subject: Re: [Leish-l] Single-Dose Therapy for Visceral Leishmaniasis<BR>To: <A href="http://ca.mc632.mail.yahoo.com/mc/compose?to=jayusp@hotmail.com" ymailto="mailto:jayusp@hotmail.com">jayusp@hotmail.com</A>; <A
href="http://ca.mc632.mail.yahoo.com/mc/compose?to=leish-l@lineu.icb.usp.br" ymailto="mailto:leish-l@lineu.icb.usp.br">leish-l@lineu.icb.usp.br</A><BR>Dear all,<BR><BR>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?<BR>Seife Bashaye,<BR>RTI /PMI, Ethiopia<BR><BR>________________________________<BR>From: jeffrey shaw <<A href="http://ca.mc632.mail.yahoo.com/mc/compose?to=jayusp@hotmail.com" ymailto="mailto:jayusp@hotmail.com">jayusp@hotmail.com</A>><BR>To: Leish-L <<A href="http://ca.mc632.mail.yahoo.com/mc/compose?to=leish-l@lineu.icb.usp.br" ymailto="mailto:leish-l@lineu.icb.usp.br">leish-l@lineu.icb.usp.br</A>><BR>Sent: Thu, February 11, 2010 8:07:55 AM<BR>Subject: [Leish-l]
Single-Dose Therapy for Visceral Leishmaniasis<BR>Summary and Comment<BR>Single-Dose Therapy for Visceral Leishmaniasis<BR>A single infusion of liposomal amphotericin B was not inferior to a 15-dose regimen of amphotericin B deoxycholate.<BR>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.<BR>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).<BR>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).<BR>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.<BR>— Larry M. Baddour, MD<<A href="http://infectious-diseases.jwatch.org/misc/board_about.dtl?q=etoc_jwid#aBaddour" target=_blank>http://infectious-diseases.jwatch.org/misc/board_about.dtl?q=etoc_jwid#aBaddour</A>><BR>Published in Journal Watch Infectious Diseases<<A href="http://infectious-diseases.jwatch.org/" target=_blank>http://infectious-diseases.jwatch.org/</A>> February 10, 2010<BR>Citation(s):<BR>Sundar S et al. Single-dose liposomal amphotericin B for visceral leishmaniasis in India. N Engl J Med 2010 Feb 11; 362:504.<BR><BR>_______________________________________________<BR>Leish-l mailing list<BR><A href="http://ca.mc632.mail.yahoo.com/mc/compose?to=Leish-l@lineu.icb.usp.br" ymailto="mailto:Leish-l@lineu.icb.usp.br">Leish-l@lineu.icb.usp.br</A><BR><A href="http://lineu.icb.usp.br/cgi-bin/mailman/listinfo/leish-l"
target=_blank>http://lineu.icb.usp.br/cgi-bin/mailman/listinfo/leish-l</A><BR></DIV></BLOCKQUOTE></td></tr></table><br>
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