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- Title
Effectiveness of miltefosine in cutaneous leishmaniasis caused by Leishmania tropica in Pakistan after antimonial treatment failure or contraindications to first line therapy—A retrospective analysis.
- Authors
Kämink, Suzette; Masih, Boota; Ali, Noor; Ullah, Aman; Khan, Syed Juma; Ashraf, Shakil; Pylypenko, Tetyana; Grobusch, Martin P.; Fernhout, Jena; den Boer, Margriet; Ritmeijer, Koert
- Abstract
Background: Cutaneous leishmaniasis (CL) is a neglected tropical skin disease, caused by Leishmania protozoa. In Pakistan, where CL caused by L. tropica is highly endemic, therapy with pentavalent antimonials is the standard of care, but has significant toxicity when used in systemic therapy, while are no evidence-based safer alternative treatment options for L. tropica. The efficacy of oral miltefosine has not been studied in CL caused by L. tropica. We evaluated effectiveness and tolerability of miltefosine in patients with previous treatment failure or with contraindications to systemic antimonial treatment. Methods: A retrospective review was conducted of a cohort of CL patients who were treated with a 28-day course of miltefosine between December 2017 and August 2019, in urban Quetta, Pakistan, an area endemic for L. tropica. Descriptive analyses were performed, and effectiveness was assessed by initial response after treatment, and final cure at routine follow up visits, six weeks to three months post-treatment. Tolerability was assessed by routinely reported adverse events. Results: Of the 76 CL patients in the cohort, 42 (55%) had contraindications to systemic antimonial treatment, and 34 (45%) had failure or relapse after antimonial treatment. Twelve patients defaulted during treatment and 12 patients were lost to follow up. In the remaining 52 patients, final cure rate was 77% (40/52). In those with contraindications to systemic antimonial treatment the final cure rate was 83% (24/29) and in the failure and relapse group 70% (16/23). Twenty-eight patients (40.0%) reported 39 mild to moderate adverse events with the main complaints being nausea (41.0%), general malaise (25.6%), and stomach pain (12.8%). Conclusion: Results indicate that miltefosine is an effective second line treatment in CL in areas endemic for L. tropica. Prospective studies with systematic follow up are needed to obtain definitive evidence of effectiveness and tolerability, including identification of risk factors for miltefosine treatment failure. Author summary: Cutaneous Leishmaniasis (CL) is a neglected tropical skin disease, which globally affects an estimated 0.6 to 1 million people. The skin disease is caused by the protozoa Leishmania and is transmitted by phlebotomine sandflies in Old World CL (OWCL). In Pakistan, CL is highly endemic, especially in the provinces Balochistan and Khyber Pashtunkwa, where L. tropica is the main causative species. In this context, untreated CL often leads to stigmatisation and severe (psycho)social suffering, due to the disfiguring ulcerating wounds and scars. The mainstay treatment is with pentavalent antimonials, and evidence for efficacy of alternative treatments for L. tropica is lacking. Médecins sans Frontières (MSF) has specialised treatment centres in Balochistan (Quetta and Kuchlak), where in December 2017 miltefosine was introduced for patients who did not respond to, or had contraindications for antimonials. In this study, we showed favourable outcomes of miltefosine as second-line treatment for these CL patients.
- Subjects
PAKISTAN; BALUCHISTAN; QUETTA (Pakistan); CUTANEOUS leishmaniasis; LEISHMANIA; RETROSPECTIVE studies; LONGITUDINAL method; TREATMENT failure; CONTRAINDICATIONS; MILTEFOSINE
- Publication
PLoS Neglected Tropical Diseases, 2021, Vol 15, Issue 1, p1
- ISSN
1935-2727
- Publication type
Article
- DOI
10.1371/journal.pntd.0008988