[Leish-l] Single-Dose Therapy for Visceral Leishmaniasis
jeffrey shaw
jayusp at hotmail.com
Thu Feb 11 11:07:55 BRST 2010
Summary
and Comment
Single-Dose Therapy for Visceral LeishmaniasisA 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
Published in Journal Watch Infectious
Diseases 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.
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://lineu.icb.usp.br/pipermail/leish-l/attachments/20100211/1e011b62/attachment.html>
More information about the Leish-l
mailing list