The recommended treatment for visceral leishmaniasis in eastern Africa (17-day treatment of sodium stibogluconate with paromomycin) is painful, causes adverse events, and requires hospitalisation. 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. 3 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.
This is part of the Drugs for Neglected Diseases initiative (DNDi).
Wasunna M, Njenga S, Balasegaram M, Alexander N, Omollo R, Edwards T, et al. (2016) Efficacy and Safety of AmBisome in Combination with Sodium Stibogluconate or Miltefosine and Miltefosine Monotherapy for African Visceral Leishmaniasis: Phase II Randomized Trial. PLoS Negl Trop Dis10(9): e0004880. https://doi.org/10.1371/journal.pntd.0004880
Efficacy and safety of AmBisome in combination with sodium stibogluconate or miltefosine and miltefosine monotherapy for African visceral leishmaniasis: Phase II randomized trial
Published 1 September 2016