Currently, first-line treatment recommendations for visceral leishmaniasis in Brazil include the use of meglumine antimoniate, 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 the efficacy and safety of various treatment options compared to standard treatment with meglumine antimoniate. 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.

In 2013, based on the interim safety data from the trial, Brazil’s national guidelines for visceral leishmaniasis were revised to include treatment with liposomal amphotericin B for some patients.

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.

Project updates

2020

The Brazilian Ministry of Health is reviewing its treatment policy to consider the adoption of liposomal amphotericin B as the country’s first-line visceral leishmaniasis treatment. In addition, the evidence for leishmaniasis treatment in the Americas will be revised by the WHO Guideline Development Group (GDG) in 2021, with the expectation that Ambisome will be adopted in the new guidelines.

2019

The Brazilian Ministry of Health is reviewing its treatment policy to consider the adoption of liposomal amphotericin B as the country’s first-line visceral leishmaniasis treatment.

2018

The Brazilian Ministry of Health is still reviewing its treatment policy to consider the adoption of AmBisome as the country’s first-line visceral leishmaniasis treatment.

2017

The Brazilian Ministry of Health is reviewing its policy with regard to the adoption of AmBisome® as first-line treatment for visceral leishmaniasis.

2016

The final results of this trial were presented to the Ministry of Health, and are expected to guide further policy change in Brazil as of 2017.