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<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>Dear all,<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>This is just to let you know that the <st1:PersonName
w:st="on">Drugs for Neglected Diseases initiative</st1:PersonName> and Leishmania
East Africa Platform (DNDi and LEAP) is conducting a trial on the minimum
effective doses of Ambisome in <st1:country-region w:st="on">Ethiopia</st1:country-region>
and <st1:country-region w:st="on"><st1:place w:st="on">Sudan</st1:place></st1:country-region>.
Information on this trial is available on clinical trials.gov. Recruitment is
currently ongoing in both countries.<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>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.<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>Many regards<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Arial><span lang=FR style='font-size:10.0pt;
font-family:Arial'>Dr <st1:PersonName w:st="on">Manica Balasegaram</st1:PersonName></span></font><span
lang=FR><o:p></o:p></span></p>
<p class=MsoNormal><font size=2 face=Arial><span lang=FR style='font-size:10.0pt;
font-family:Arial'>Project Manager<o:p></o:p></span></font></p>
<p class=MsoNormal><st1:PersonName w:st="on"><font size=2 face=Arial><span
lang=FR style='font-size:10.0pt;font-family:Arial'>Drugs for Neglected
Diseases<i><span style='font-style:italic'> initiative</span></i></span></font></st1:PersonName><font
size=2 face=Arial><span lang=FR style='font-size:10.0pt;font-family:Arial'><o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Arial><span lang=FR style='font-size:10.0pt;
font-family:Arial'>email: </span></font><a href="mailto:mbalasegaram@dndi.org"
title="mailto:mbalasegaram@dndi.org"><font size=2 face=Arial><span lang=FR
style='font-size:10.0pt;font-family:Arial'><span
title="mailto:mbalasegaram@dndi.org">mbalasegaram@dndi.org</span></span></font></a><span
lang=FR><o:p></o:p></span></p>
<p class=MsoNormal><font size=2 face=Arial><span lang=FR style='font-size:10.0pt;
font-family:Arial'>Tel: +41 22 906 9237</span></font><span lang=FR><o:p></o:p></span></p>
<p class=MsoNormal><font size=2 face=Arial><span lang=FR style='font-size:10.0pt;
font-family:Arial'>Mobile: +41 79 276 2283</span></font><span lang=FR><o:p></o:p></span></p>
<p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><font
size=3 face="Arial Narrow"><span lang=FR style='font-size:12.0pt;font-family:
"Arial Narrow"'>15 Chemin Louis Dunant<br>
1202 Geneva<br>
</span></font><font size=2 face=Arial><span lang=FR style='font-size:10.0pt;
font-family:Arial'>Switzerland</span></font><br>
<a href="http://www.dndi.org/" title="http://www.dndi.org/"><font size=2
face=Arial><span lang=FR style='font-size:10.0pt;font-family:Arial'><span
title="http://www.dndi.org/"><span title="http://www.dndi.org/"><span
title="http://www.dndi.org/">www.dndi.org</span></span></span></font></span></a><o:p></o:p></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<div>
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<p class=MsoNormal><b><font size=2 face=Tahoma><span style='font-size:10.0pt;
font-family:Tahoma;font-weight:bold'>From:</span></font></b><font size=2
face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma'>
leish-l-bounces@lineu.icb.usp.br [mailto:leish-l-bounces@lineu.icb.usp.br] <b><span
style='font-weight:bold'>On Behalf Of </span></b>jeffrey shaw<br>
<b><span style='font-weight:bold'>Sent:</span></b> Friday, February 12, 2010
11:38 AM<br>
<b><span style='font-weight:bold'>To:</span></b> Leish-L<br>
<b><span style='font-weight:bold'>Subject:</span></b> [Leish-l] FW: Single-Dose
Therapy for Visceral Leishmaniasis</span></font><o:p></o:p></p>
</div>
<p class=MsoNormal><font size=3 face="Times New Roman"><span style='font-size:
12.0pt'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 face=Verdana><span style='font-size:10.0pt;
font-family:Verdana'><o:p> </o:p></span></font></p>
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face=Verdana><span style='font-size:10.0pt;font-family:Verdana'>
<hr size=2 width="100%" align=center id=stopSpelling>
</span></font></div>
<p class=MsoNormal style='margin-bottom:12.0pt'><font size=2 face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Date: Thu, 11 Feb 2010 22:58:51
-0800<br>
From: s_bashaye@yahoo.com<br>
Subject: Re: [Leish-l] Single-Dose Therapy for Visceral Leishmaniasis<br>
To: jayusp@hotmail.com; leish-l@lineu.icb.usp.br<o:p></o:p></span></font></p>
<div>
<div>
<p class=MsoNormal><font size=3 face=Arial><span style='font-size:12.0pt;
font-family:Arial'>Dear all,<o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=3 face=Arial><span style='font-size:12.0pt;
font-family:Arial'> <o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal style='text-align:justify'><font size=3 color=black
face=Arial><span style='font-size:12.0pt;font-family:Arial;color:black'>It is
good news to Developing countries like <st1:country-region w:st="on"><st1:place
w:st="on">Ethiopia</st1:place></st1:country-region>. 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 <st1:country-region
w:st="on"><st1:place w:st="on">Ethiopia</st1:place></st1:country-region>?</span></font><font
face=Arial><span style='font-family:Arial'><o:p></o:p></span></font></p>
<p class=MsoNormal style='text-align:justify'><font size=3 color=black
face=Arial><span style='font-size:12.0pt;font-family:Arial;color:black'>Seife
Bashaye,</span></font><font face=Arial><span style='font-family:Arial'><o:p></o:p></span></font></p>
<p class=MsoNormal style='text-align:justify'><font size=3 color=black
face=Arial><span style='font-size:12.0pt;font-family:Arial;color:black'>RTI
/PMI, <st1:country-region w:st="on"><st1:place w:st="on">Ethiopia</st1:place></st1:country-region></span></font><font
face=Arial><span style='font-family:Arial'><o:p></o:p></span></font></p>
</div>
<div>
<p class=MsoNormal><font size=3 face=Arial><span style='font-size:12.0pt;
font-family:Arial'><o:p> </o:p></span></font></p>
<div>
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face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma'>
<hr size=1 width="100%" align=center>
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<p class=MsoNormal style='margin-bottom:12.0pt'><b><font size=2 face=Tahoma><span
style='font-size:10.0pt;font-family:Tahoma;font-weight:bold'>From:</span></font></b><font
size=2 face=Tahoma><span style='font-size:10.0pt;font-family:Tahoma'> jeffrey
shaw <jayusp@hotmail.com><br>
<b><span style='font-weight:bold'>To:</span></b> Leish-L
<leish-l@lineu.icb.usp.br><br>
<b><span style='font-weight:bold'>Sent:</span></b> Thu, February 11, 2010
8:07:55 AM<br>
<b><span style='font-weight:bold'>Subject:</span></b> [Leish-l] Single-Dose
Therapy for Visceral Leishmaniasis</span></font><o:p></o:p></p>
<p class=MsoNormal style='margin-bottom:3.75pt'><font size=1
face="Times New Roman"><span style='font-size:8.5pt'>Summary and Comment<o:p></o:p></span></font></p>
<h3 style='margin-bottom:1.5pt'><b><font size=3 face="Times New Roman"><span
style='font-size:11.5pt'>Single-Dose Therapy for Visceral Leishmaniasis<o:p></o:p></span></font></b></h3>
<p class=MsoNormal style='margin-bottom:7.5pt'><em><i><font size=1
face="Times New Roman"><span style='font-size:9.0pt'>A single infusion of
liposomal amphotericin B was not inferior to a 15-dose regimen of amphotericin
B deoxycholate.</span></font></i></em><font size=1><span style='font-size:9.0pt'><o:p></o:p></span></font></p>
<div style='margin-bottom:5.25pt'>
<p class=MsoNormal><font size=1 face="Times New Roman"><span style='font-size:
9.0pt'>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 <st1:country-region
w:st="on"><st1:place w:st="on">India</st1:place></st1:country-region>, 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>
<b><span style='font-weight:bold'>Comment:</span></b> 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>
<b><i><span style='font-weight:bold;font-style:italic'>— <a
href="http://infectious-diseases.jwatch.org/misc/board_about.dtl?q=etoc_jwid#aBaddour">Larry
M. Baddour, MD</a></span></i></b><br>
<i><span style='font-style:italic'>Published in</span></i> <a
href="http://infectious-diseases.jwatch.org/">Journal Watch Infectious Diseases</a>
<i><span style='font-style:italic'>February 10, 2010</span></i><o:p></o:p></span></font></p>
</div>
<p class=MsoNormal style='margin-bottom:3.75pt'><b><font size=1
face="Times New Roman"><span style='font-size:8.5pt;font-weight:bold'>Citation(s):<o:p></o:p></span></font></b></p>
<p class=MsoNormal style='margin-bottom:1.5pt'><a name=ref></a><font size=1
face="Times New Roman"><span style='font-size:8.5pt'>Sundar S et al.
Single-dose liposomal amphotericin B for visceral leishmaniasis in <st1:country-region
w:st="on"><st1:place w:st="on">India</st1:place></st1:country-region>. <st1:place
w:st="on"><em><i><font face="Times New Roman">N Engl</font></i></em></st1:place><em><i><font
face="Times New Roman"> J Med</font></i></em> 2010 Feb 11; 362:504.<o:p></o:p></span></font></p>
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<p class=MsoNormal><font size=2 face=Verdana><span style='font-size:10.0pt;
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