- Target disease: Visceral leishmaniasis (VL)
- Main partners (since project start): BRAZIL: Brasilia University; Hospital Sao José de Doencas Infecciosas; Leishmaniasis Control Programme/Ministry of Health; Montes Claros State University; Paediatric Hospital Joao Paulo II – FHEMIG; Piaui Federal University; Rene Rachou Research Center– Fiocruz-MG; Sergipe Federal University; Universidade Estadual do Rio de Janeiro.
- Project start: February 2011
- Funding (since project start): Associação Bem-Te-Vi Diversidade, Brazil; CNPq/FINEP; Department for International Development (DFID), UK; Médecins Sans Frontières/Doctors without Borders, International; Medicor Foundation, Liechtenstein; Ministry of Health, Brazil; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Other private foundations and individuals.
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.
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.
The Brazilian Ministry of Health is reviewing its policy with regard to the adoption of AmBisome® as first-line treatment for visceral leishmaniasis.
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.
Last update: August 2019