Effectiveness and Safety of Short Course Liposomal Amphotericin B (AmBisome) as First Line Treatment for Visceral Leishmaniasis in Bangladesh

Citation: Lucero E, Collin SM, Gomes S, Akter F, Asad A, Kumar Das A, et al. (2015) Effectiveness and Safety of Short Course Liposomal Amphotericin B (AmBisome) as First Line Treatment for Visceral Leishmaniasis in Bangladesh. PLoS Negl Trop Dis 9(4): e0003699. doi:10.1371/journal.pntd.0003699
Published: April 2, 2015

Abstract
Background: Bangladesh is one of the endemic countries for Visceral Leishmaniasis (VL). Médecins Sans Frontières (MSF) ran a VL treatment clinic in the most endemic district (Fulbaria) between 2010 and 2013 using a semi-ambulatory regimen for primary VL of 15mg/kg Liposomal Amphotericin-B (AmBisome) in three equal doses of 5mg/kg. The main objective of this study was to analyze the effectiveness and safety of this regimen after a 12 month follow-up period by retrospective analysis of routinely collected program data. A secondary objective was to explore risk factors for relapse.
Methods and Principal Findings: Our analysis included 1521 patients who were initially cured, of whom 1278 (84%) and 1179 (77.5%) were followed-up at 6 and 12 months, respectively. Cure rates at 6 and 12 months were 98.7% (1262/1278) and 96.4% (1137/1179), respectively. Most relapses (26/39) occurred between 6 and 12 months after treatment. Serious adverse events (SAE) were recorded for 7 patients (0.5%). Odds of relapse at 12 months were highest in the youngest and oldest age groups. There was some evidence that spleen size measured on discharge (one month after initiation of treatment) was associated with risk of relapse: OR=1.25 (95% CI 1.01 to 1.55) per cm below lower costal margin (P=0.04).
Conclusions: Our study demonstrates that 15mg/kg AmBisome in three doses of 5mg/kg is an effective (>95% cure rate) and safe (<1% SAE) treatment for primary VL in Bangladesh. The majority of relapses occurred between 6 and 12 months, justifying the use of a longer follow-up period when feasible. Assessment of risk of relapse based on easily measured clinical parameters such as spleen size could be incorporated in VL treatment protocols in resource-poor settings where test-of-cure is not always feasible.

Author Summary: Visceral Leishmaniasis (VL) is a parasitic disease which is endemic in more than 80 countries, although 90% of cases occur in India, Bangladesh, Sudan, South Sudan, Ethiopia and Brazil. Most treatments are complex, expensive and require long application periods. AmBisome is one of the newest treatments available, but evidence for its safety and effectiveness under routine program conditions in resource-poor endemic areas remains sparse. Médecins Sans Frontières (MSF) ran a VL clinic from 2010 until 2014 in Fulbaria District, Bangladesh. Our retrospective study was based on all available data from this clinic, comprising 1521 patients diagnosed with primary VL who were treated with AmBisome 15mg/kg in three equal doses of 5mg/kg. We found that this treatment was safe (less than 1% of patients experienced a severe adverse event) and effective (more than 95% of patients were cured with one treatment) after 12 months. The youngest and oldest patients, and patients with large spleen size at the end of treatment, were more likely to experience a relapse. More than half of the relapses occurred between 6 and 12 months after treatment, therefore we recommend that clinical trials and treatment protocols adopt a minimum 12-month follow-up period.

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