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- Title
Miltefosine for the treatment of cutaneous leishmaniasis—A pilot study from Ethiopia.
- Authors
van Henten, Saskia; Tesfaye, Annisa Befekadu; Abdela, Seid Getahun; Tilahun, Feleke; Fikre, Helina; Buyze, Jozefien; Kassa, Mekibib; Cnops, Lieselotte; Pareyn, Myrthe; Mohammed, Rezika; Vogt, Florian; Diro, Ermias; van Griensven, Johan
- Abstract
Background: Cutaneous leishmaniasis (CL) in Ethiopia, caused by Leishmania aethiopica, is often severe and hard to treat compared to CL caused by other species elsewhere. Miltefosine is the only oral anti-leishmanial drug, with a favorable side-effect profile compared to routinely available sodium stibogluconate (SSG), but evidence about its use for L. aethiopica is lacking. Methodology and principal findings: In an observational cohort study, treatment outcomes, safety and adherence among CL patients who required systemic treatment and received miltefosine for 28 days in Boru Meda Hospital and University of Gondar Hospital were studied. Patient cure was defined as 100% flattening for non-ulcerated lesions and 100% flattening and 100% re-epithelization for ulcerated lesions. Outcomes were documented for day 28, 90 and 180, both per site, and pooled, adjusting for site as a fixed effect with effect coding. Among 94 included patients (32 in Gondar, 62 in Boru Meda), median lesion duration was 12 months, median size six cm, and mucosal involvement (46.8%) and diffuse (30.9%) lesions were common. Adherence to miltefosine was good, and side-effects were tolerable. Initial outcomes at day 28 were promising, with 68.8% and 94.0% of patients having good improvement or cure in Gondar and Boru Meda respectively. In Boru Meda, outcomes were good with 72.7% and 72.9% cure at day 90 and day 180 respectively. In Gondar, results were less promising, with only 12.5% and 26.7% cure at day 90 and day 180, although confidence intervals were wide. In pooled estimates, 48.7% of patients reached cure at day 180, and 32.3% relapsed. Outcomes were better in Boru Meda Hospital, for smaller lesions and for mucosal lesions. Conclusions/Significance: Based on miltefosine's good initial response, tolerable side-effects, tablet-form, we propose to include miltefosine for future clinical trials using extended treatment schedules, combination therapy, or targeting specific subgroups. Trial registration: ClinicalTrials.gov NCT04004754. Author summary: Cutaneous leishmaniasis (CL) in Ethiopia is caused by Leishmania aethiopica, resulting in relatively severe lesions, which are hard to treat. Currently, most patients are treated with pentavalent antimonials, although effectiveness seems poor, with many patients requiring repeated treatment cycles before good response is seen. Miltefosine is the only oral drug available for leishmaniasis treatment and has a good safety profile compared to other treatment options. Although evidence on the use of miltefosine for CL in other regions looks promising, reports from Ethiopia are lacking. We systematically recorded outcomes and side-effects for patients with CL lesions that required systemic treatment and who were treated with 28 days of miltefosine in a prospective study in two hospitals in Ethiopia. Side-effects were common but generally mild. Although all patients showed improvement after 28 days, overall, around half of patients were cured after six months, with relapse being common. Therefore, we propose to include miltefosine in future clinical trials, but to adapt the treatment regimen using combination therapy or treatment extension to improve overall outcomes and reduce relapse.
- Subjects
ETHIOPIA; GONDAR (Ethiopia); CUTANEOUS leishmaniasis; PILOT projects; UNIVERSITY hospitals; TREATMENT effectiveness; LEISHMANIASIS; MILTEFOSINE
- Publication
PLoS Neglected Tropical Diseases, 2021, Vol 15, Issue 5, p1
- ISSN
1935-2727
- Publication type
Article
- DOI
10.1371/journal.pntd.0009460