Assess the safety and efficacy of safer alternatives to the current standard visceral leishmaniasis treatment in Brazil
current phase of drug development
updated 29 Feb 2020
First-line treatment recommendations in Brazil include the use of meglumine antimoniate (MA), which presents serious patient management limitations due to toxicity, parenteral administration, and the need for hospitalization.
Starting in 2011, a multicentre, randomized, open label, controlled trial was conducted in five sites in Brazil to evaluate efficacy and safety of various treatment options, compared to standard treatment with MA. Results showed that due to lower toxicity and acceptable efficacy, liposomal amphotericin B would be a more suitable first-line treatment for visceral leishmaniasis than standard treatment.
Brazil’s national guidelines for visceral leishmaniasis were revised in 2013 based on the interim safety data from the trial.
The Brazilian Ministry of Health is currently reviewing its treatment policy to consider adoption of liposomal amphotericin B as the country’s first-line visceral leishmaniasis treatment.
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