Liposomal amphotericin B for complicated visceral leishmaniasis (kala‐azar) in eastern Sudan: how effective is treatment for this neglected disease?

Abstract

Abstractobjectives The aim of this study was to report the patient profile and treatment outcomes, including relapses, of patients with visceral leishmaniasis (VL) treated with liposomal amphotericin B (AmBisome) in Gedaref, Sudan.methods AmBisome was offered to two groups of patients: primary VL patients with specific criteria (age ≤2 or ≥45 years, advanced clinical disease, pregnancy, HIV co-infection and contraindications for antimonials) and VL relapses. AmBisome was given at a total dose of 30 mg/kg, over 10 days. Slow responders received up to 50 mg/kg. Treatment failure was confirmed parasitologically. Standardised treatment outcomes were assessed.results Between March 2010 and June 2012, a total of 281 (74%) patients with primary VL and 98 (26%) patients with VL relapses received AmBisome (54% male, median age = 11 years, interquartile range 2-30). End-of-treatment outcomes for primary VL were 260 (92%) initial cure including three (1%) slow responders, three (1%) treatment failures, 14 (5%) deaths and four (1%) unknown outcomes. Outcomes for VL relapses were 92 (94%) initial cure with five (5%) slow responders, four (4%) treatment failures, one (1%) death and one (1%) unknown outcome. At 6 months, there were 19 (7%) relapses amongst primary VL and 10 (10%) VL relapses had a new relapse. Loss to follow-up in both groups was 38%. None of the deaths that occurred during the study period was attributed to AmBisome.

Sodium stibogluconate and paromomycin for treating visceral leishmaniasis under routine conditions in eastern Sudan

“…having any severity factor) [12], non-response to SSG/PM (Box 1), or VL relapse after SSG/PM or liposomal amphotericin B. These individuals are offered second-line treatment consisting 10 consecutive days of 3mg/kg intravenous liposomal amphotericin B (AmBisome, Gilead Sciences Adapted from Salih et al [7].…”

“…In Sudan, based on national and MSF protocol, SSG/PM is also recommended for patients who, prior to 2010, had received SSG monotherapy and then presented with a relapse, that is were considered a treatment failure. Although the rationale for this recommendation is not clear, it may have been related to lower cost and scarcity of evidence to recommend alternative drugs such as liposomal amphotericin B (AmBisome, Gilead Sciences, USA) [7]. There is, however, a genuine concern that the SSG/PM regimen may not be effective in patients who have previously received SSG as they may already be non-responsive to this drug and as such, effectively on 'monotherapy' with PM.…”

Current treatment of visceral leishmaniasis (Kala-azar): an overview

“…[35][36][37] Another prospective study, also carried out in Spain, analyzed the efficacy of maintenance therapy with liposomal amphotericin B at 4 mg/kg/day for 5 days and once weekly for 5 more weeks (total 10 doses), achieving up to 80% patients being free of disease after 12 months of follow up. [39][40][41] Pentavalent antimonials were administered every 3-4 weeks as maintenance therapy in a study conducted in Spain. The rate of relapses reduced much more significantly than in those patients who either did not receive any treatment or who took allopurinol for the 12 months of follow-up.…”

An update on pharmacotherapy for leishmaniasis

“…38% were lost to follow up and 6% were slow responders requiring total dose of 50mg/kg of L AmB. 76 This study reemphasizes the fact that L.donovani in East Africa requires higher doses of L AmB than in India.…”