Suzette Kämink1,2, Boota Masih1, Noor Ali1, Aman Ullah1, Syed Juma Khan1, Shakil Ashraf3, Tetyana Pylypenko4, Martin P Grobusch2, Jena Fernhout5, Margriet den Boer6, Koert Ritmeijer5. 1. Médecins Sans Frontières, Quetta, Pakistan. 2. Center of Tropical Medicine and Travel Medicine, Department of Infectious Diseases, Amsterdam University Medical Centers, location AMC, Amsterdam Public Health, Amsterdam Infection and Immunity, University of Amsterdam, Amsterdam, The Netherlands. 3. Mohtarma Shaheed Benazir Bhutto General Hospital,Quetta, Pakistan. 4. Médecins Sans Frontières, Islamabad, Pakistan. 5. Médecins Sans Frontières, Amsterdam, the Netherlands. 6. Médecins Sans Frontières, London, United Kingdom.
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.
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.
Authors: Jorge D Marco; Abdul M Bhutto; Farooq R Soomro; Javed H Baloch; Paola A Barroso; Hirotomo Kato; Hiroshi Uezato; Ken Katakura; Masataka Korenaga; Shigeo Nonaka; Yoshihisa Hashiguchi Journal: Am J Trop Med Hyg Date: 2006-08 Impact factor: 2.345
Authors: M Karamian; M H Motazedian; M Fakhar; K Pakshir; F Jowkar; H Rezanezhad Journal: J Eur Acad Dermatol Venereol Date: 2008-03-21 Impact factor: 6.166