Article

Safety and effectiveness of Amphotericin B deoxycholate for the treatment of visceral leishmaniasis in Uganda

Médecins Sans Frontières, Swiss Section, Rue de Lausanne 78, 1202 Geneva, Switzerland.
Pathogens and Global Health (Impact Factor: 1.66). 09/2008; 102(1):11-9. DOI: 10.1179/136485908X252142
Source: PubMed

ABSTRACT Between September 2003 and April 2004, the supply of antimonial drugs to Amudat Hospital, in north-eastern Uganda, was interrupted and all cases of visceral leishmaniasis presenting at the hospital could only be treated with amphotericin B deoxycholate (AmB). This allowed the safety and effectiveness of the AmB to be evaluated, in comparison with an historical cohort of patients treated, at the same hospital, with meglumine antimoniate (Sb(V)). Demographic and clinical data were collected before and after treatment. Adverse effects were recorded passively in all the subjects, and actively, using a standardized questionnaire, in a sub-group of the patients given AmB. The in hospital case-fatality 'rates' were 4.8% [95% confidence interval (CI) = 2.4%-8.8%] among the 210 patients treated with AmB and 3.7% (CI = 1.4%-7.9%) among the 161 patients treated with Sb(V) (P>0.20). Adverse effects requiring treatment interruption were rare in both cohorts. Treatment failures (i.e. non-responses or relapses) were observed in 2.9% (CI = 1.2%-6.4%) of the patients treated with AmB and 1.2% (CI = 0.1%-4.4%) of the patients treated with Sb(V) (P>0.20). For the treatment of visceral leishmaniasis in Uganda, AmB therefore had a similar effectiveness and safety profile to that of meglumine antimoniate.

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    • "In fact, in Europe, lipid preparations of amphotericin B are used as first-line treatment or in those cases where antimonials have previously failed [44]. In Uganda, a cure rate of 92.4 % was obtained with amphotericin B deoxycholate at a dose of 1 mg/kg on alternate days for a period of 30 days, similar to the cure rate in a historical cohort treated with antimonials and without any difference in the occurrence of severe side effects [41]. A retrospective study of five cases of VL in Tunisia treated with amphotericin B deoxycholate at a dose of 0.5–1 mg/kg/day for an average of 25 days obtained a 100 % response rate [57]. "
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    • "Second-line treatment was intravenous ampB deoxycholate 1 mg ⁄ kg on alternate days for 30 days (15 doses). AmpB deoxycholate had to be introduced as first-line treatment during a 9-month shortage of GlucantimeÔ (August 2003– April 2004) (Mueller et al. 2008). Sodium stibogluconate (PentostamÔ) was then used as the first-line treatment from May 2004 until December 2005. "
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