Use of miltefosine in the treatment of cutaneous leishmaniasis in French Guiana

Abstract

Background

Nearly half of the cutaneous leishmaniasis (CL) cases in French Guiana occur in remote rainforest areas. The treatment of pentamidine-resistant strains currently requires hospitalisation for intravenous amphotericin, involving significant indirect costs. Miltefosine is currently the only oral drug available but is only used in French Guiana as a third- or fourth-line treatment under a temporary use authorisation.

Objectives

The primary objective of this study was to evaluate the effectiveness of miltefosine in French Guiana. Secondary objectives were to evaluate its safety and acceptability, and patient satisfaction.

Methods

The study was carried out at the Cayenne Hospital and remote health centres in French Guiana. All patients with proven CL and treated with miltefosine between 1 January 2017 and 1 April 2022 were included. Cure was defined as complete re-epithelisation with no new lesions at 90 days. Adherence (all doses taken) and side effects were routinely evaluated at the end of treatment. Patients were retrospectively called back to evaluate the impact of CL on their life quality before treatment and their satisfaction with miltefosine.

Results

Fifteen patients were included. The main species was Leishmania guyanensis (n = 9; 60%), followed by L. braziliensis (n = 4; 26.7%). Eight patients (53.3%) were cured. Eleven patients (73.3%) presented adverse effects (mainly digestive), with seven of these (46.7%) requiring therapeutic adaptations. Eight patients demonstrated complete adherence; of these, six (75%) were cured, including six cases of L. guyanensis, one case of L. braziliensis and one Leishmania spp. Most patients (88.9%) were satisfied with the treatment and said they preferred oral administration to the parenteral route.

Conclusions

Miltefosine is a valuable treatment option for CL in French Guiana. The side effects can diminish patient adherence, but its oral administration is associated with high patient satisfaction. A regular marketing authorisation would facilitate its prescription and allow for the creation of larger cohorts.