Sodium stibogluconate 10g/100ml solution for injection vials

BACKGROUND: Ethiopia is a high-burden country for visceral leishmaniasis (VL) and has committed to regional elimination by 2030. Current evidence on disease epidemiology, transmission dynamics, treatment access, and clinical outcomes is essential for transitioning from control to elimination efforts. This systematic review and meta-analysis synthesizes the available literature on the prevalence, associated risk factors, accessibility and effectiveness of treatment, transmission patterns, clinical outcomes, and ecological factors influencing VL distribution, including vector habitats, climate conditions, and land-use patterns. METHODS: Literature searches were conducted using PubMed, SCOPUS, EMBASE, CINAHL, HINARI, ScienceDirect, Google Scholar, and grey literature sources following PRISMA 2020 reporting guidelines. Study quality was assessed using the Joanna Briggs Institute (JBI) tools. Random-effects meta-analyses were used to estimate pooled prevalence and associated risk factors. In addition to systematic review and meta-analysis, we conducted a descriptive analysis of WHO surveillance data to assess the trend of caseload, treatment access, and cured treatment outcomes using R software version 4.5.1 and ArcGIS version 10.7, respectively. RESULTS: The study revealed that pooled VL prevalence (32 studies, 103,962 participants) was 15.29% (95% CI: 9.25–22.51) in institution-based and 10.38% (95% CI: 5.38–16.74) in community-based settings, with substantial variation according to detection methods employed. Male sex (OR = 1.86), sleeping outdoors (OR = 2.85) or on the ground (OR = 1.92), and travel to endemic areas (OR = 3.99) were significantly associated with VL infection. Family history of VL (OR = 2.27) and rural residence (OR = 2.27) increased VL risk substantially. Environmental factors, including proximity to termite mounds (OR = 3.60), presence of acacia trees (OR = 3.75), and hyraxes near dwellings (OR = 1.90), were significantly associated with increased VL risk. Spatial analysis revealed persistent VL transmission with intermittent outbreaks concentrated in high and very high VL-risk areas, primarily in the Kolla and Lower Kolla agroecological zones. Geographic inequities in treatment access were evident, with higher case numbers treated in northern endemic foci and increasing trends in southern and eastern foci. The sodium stibogluconate and paromomycin combination regimen demonstrated high cure rates. CONCLUSION: Visceral leishmaniasis (VL) in Ethiopia shows heterogeneous prevalence, highest with leishmanin skin tests. Male sex, farming, family history, outdoor sleeping, and proximity to termite mounds, acacia trees, and domestic animals were major risk factors. VL distribution aligned with sandfly vectors, particularly Phlebotomus orientalis, across lowlands and transitional highlands. National treatment data (2017–2024) showed generally favorable outcomes, highlighting the need for targeted elimination strategies based on local prevalence, risk factors, and effective case management. CLINICAL TRIAL NUMBER: Not applicable.

Abstract licence: CC BY-NC-ND

BackgroundCutaneous leishmaniasis (CL) is a major public health concern, particularly in Ethiopia, where about 40 000 new cases occur annually, predominantly caused by Leishmania aethiopica. Clinical phenotypes include localized CL (LCL), mucocutaneous leishmaniasis (MCL) and diffuse CL (DCL). Despite the high disease burden, treatment options and high-quality data on treatment outcomes are limited.ObjectivesTo evaluate the effectiveness of standard treatments in Ethiopia to inform future clinical trials.MethodsWe conducted an observational cohort study of patients with parasitologically confirmed cutaneous leishmaniasis at two specialized dermatology referral hospitals. Clinical- and patient-reported outcomes were assessed at baseline and at standardized times during follow-up. The primary clinical outcome measure ('cure') was complete re-epithelialization or flattening of the index lesion at day 90. Patient-reported outcomes were assessed using skin-specific and general quality-of-life scores.ResultsWe enrolled 666 participants from April 2022 to October 2023. Median patient age was 20 years (interquartile range 14-35) and 405 patients were male (60.8%). More than half (n = 372; 55.9%) had previously received traditional treatment for CL. Most participants had LCL (n = 390; 58.6%) or MCL (n = 261; 39.1%). Intramuscular sodium stibogluconate 20 mg kg-1 daily was the most frequently used systemic therapy, either alone or in combination with lesion-directed therapy (cryotherapy or intralesional sodium stibogluconate). At day 90, 28.3% (n = 83/293) of participants with LCL, 23.5% (v = 47/200) with MCL and 8% (n = 1/12) with DCL were deemed cured. By day 90, all patient-reported outcomes of skin health improved for those with LCL or MCL, but skin and CL-related quality-of-life scores did not improve for those with DCL. Most participants (n = 522/641; 81.4%) experienced at least one clinical adverse event and 7.2% (n = 46/641) had abnormal laboratory findings during treatment.ConclusionsCurrent treatment strategies have low cure rates in Ethiopia. Well-designed randomized controlled trials are urgently needed to improve management of CL caused by L. aethiopica.

Abstract licence: CC BY