Efficacy and safety of AmBisome in combination with sodium stibogluconate or miltefosine and miltefosine monotherapy for African visceral leishmaniasis: Phase II randomized trial

by Wasunna M, Njenga S, Balasegaram M, Alexander N, Omollo R, Edwards T, Dorlo TPC, Musa B, Sharaf Ali MH, Elamin MY, Kirigi G, Juma R, Anke E. Kip, Schoone GJ, Hailu A, Olobo J, Ellis S, Kimutai R, Wells S, Khalil EAG, Strub Wourgaft N, Alves F, Musa A. PLOS Neglected Tropical Diseases 2016, doi:10.1371/journal.pntd.0004880

Summary: The recommended treatment for VL in eastern Africa (17-day treatment of sodium stibogluconate with paromomycin) is painful, causes adverse events, and requires hospitalization. An affordable, safe and effective oral treatment is needed.  Combination regimens based on AmBisome and miltefosine have been shown to be safe and effective in treating Indian patients, but there are no published data on their use in Africa, where efficacy of treatments can be different. Three regimens using AmBisome in combination with sodium stibogluconate or miltefosine, or miltefosine alone were investigated in eastern Africa. Despite efficacy in India, none of the regimes showed sufficiently high definitive cure rates in Africa to evaluate in Phase III trials. The results also suggested that miltefosine was under-dosed in children.

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