Efficacy and safety of available treatments for visceral leishmaniasis in Brazil: a multicenter, randomized, open label trial

by Romero GAS, Costa DL, Costa CHN, de Almeida RP, de Melo EV, de Carvalho SFG, Rabello A, de Carvalho AL, de Queiroz Sousa A, Leite RD, Soares Lima S, Alves Amaral T, Piovesan Alves F, Rode J, the Collaborative LVBrasil Group. PLOS Neglected Tropical Diseases 2017, doi: 10.1371/journal.pntd.0005706.

Summary: There is insufficient evidence to support visceral leishmaniasis treatment recommendations in Brazil and an urgent need to improve current treatments. This study investigated the safety and efficacy of amphotericin B deoxycholate, liposomal amphotericin B, and a combination of liposomal amphotericin B plus meglumine antimoniate, compared to the standard treatment meglumine antimoniate. The amphotericin B deoxycholate treatment arm was dropped due to safety concerns. Final analyses of the remaining 332 patients show no statistically significant differences in cure rates between the experimental arms and comparator. However, liposomal amphotericin B resulted in fewer adverse events than meglumine antimoniate and so, given its lower toxicity, liposomal amphotericin B would be a more suitable first line treatment.

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