By Verrest L, Roseboom IC, Wasunna M, Mbui J, Njenga S, Musa AM, Olobo J, Mohammed R, Ritmeijer K, Chu W-Y, Huitema ADR, Solomos A, Alves F, Dorlo TPC. Journal of Antimicrobial Chemotherapy 2023. doi: doi.org/10.1093/jac/dkad286
Summary: Most patients affected by visceral leishmaniasis (VL) are children, thus adequate paediatric exposure to miltefosine and paromomycin is key to ensuring good treatment response. Two combination treatments for visceral leishmaniasis, 14- and 28-day regimens of paromomycin plus allometrically dosed miltefosine, were evaluated In a randomized controlled trial in Kenya, Sudan, Ethiopia and Uganda. Population pharmacokinetic models were developed from data collected from 265 patients, 59% of whom were aged 12 years or under. The exposure levels of paromomycin and miltefosine in this new combination regimen were within the desired parameters, supporting the implementation of the shorter 14 day regimen. Moreover, the lack of clear exposure-response and exposure-toxicity relationships indicated adequate exposure within the therapeutic range in the population studied.
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