Assessment of Safety and efficacy of Liposomal Amphotericin B AmBisome Vs Miltefosine 12 weeks therapy in patients with Post Kala Azar Dermal Leishmaniasis PKDL an observational pilot study.

PKDL is a dermal form of leishmaniasis caused by protozoal parasite Leishmania donovani, spread through the bite of infected female Phlebotomine sand flies. It is characterized by macular, papular, or nodular lesions or a mixture of these. There are very limited drugs available for the treatment of PKDL. Treatment of post‑kala‑azar dermal leishmaniasis cases is of paramount importance for kala‑azar elimination; however, limited treatment regimens are available as of now. This study compares the effectiveness of liposomal amphotericin B vs miltefosine in post‑kala‑azar dermal leishmaniasis patients. This was a randomized, open‑label, parallel‑group study. A total of 100 patients of post kala azar dermal leishmaniasis, aged between 5 and 65 years were recruited, 50 patients in each group, A (liposomal amphotericin B) and B (miltefosine). Patients were randomized to receive either liposomal amphotericin B (30 mg/kg), six doses each 5 mg/kg, biweekly for 3 weeks or miltefosine 2.5 mg/kg or 100 mg/day for 12 weeks. All the patients were followed at 3rd, 6th and 12th months after the end of the treatment. In the liposomal amphotericin B group, two patients were lost to follow‑up, whereas four patients were lost to follow‑up in the miltefosine group. The initial cure rate by “intention to treat analysis” was 98% and 100% in liposomal amphotericin B and miltefosine group, respectively. The final cure rate by “per protocol analysis” was 74.5% and 86.9% in liposomal amphotericin B and miltefosine, respectively. Twelve patients (25.5%) in the liposomal amphotericin B group and six patients (13%) in the miltefosine group relapsed. None of the patients in either group developed any serious adverse events. Efficacy of miltefosine was found to be superior compared to liposomal amphotericin B. Therefore, continued use of miltefosine as a first‑line therapy for the treatment of post‑kala‑azar dermal leishmaniasis is recommended. However, liposomal amphotericin B may be considered as one of the options for the treatment of post‑kala‑azar dermal leishmaniasis for whom miltefosine is contraindicated. This study can proved to be one of the benchmark for establishing an effective, safe and shorter duration treatment for PKDL in the Indian subcontinent, which in turn will be of great help for the kalaazar elimination program.