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<p style="font-size: 11px; margin-bottom: 5px;">Summary
and Comment</p>
<h3 style="font-size: 15px; font-weight: bold; margin-bottom: 2px;">
Single-Dose Therapy for Visceral Leishmaniasis</h3><p style="font-size: 12px; margin-bottom: 10px;"><em>A single
infusion of liposomal amphotericin B was not inferior to a 15-dose
regimen
of amphotericin B deoxycholate.</em></p><div style="font-size: 12px; margin-bottom: 7px;">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>
<b>Comment:</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>— <a href="http://infectious-diseases.jwatch.org/misc/board_about.dtl?q=etoc_jwid#aBaddour" target="_blank">Larry
M. Baddour, MD</a></i></b><BR>
<i>Published in</i> <a href="http://infectious-diseases.jwatch.org/" target="_blank">Journal Watch Infectious
Diseases</a> <i>February 10, 2010</i><BR>
</div>
<p style="font-size: 11px; margin-bottom: 5px; font-weight: bold;">Citation(s):</p>
<a name="ref" target="_blank"></a>
<p style="font-size: 11px; margin-bottom: 2px;">Sundar S
et al. Single-dose liposomal amphotericin B for visceral leishmaniasis
in
India.
<em>N Engl J Med</em>
2010 Feb 11; 362:504.</p> </body>
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