Assess the safety and efficacy of safer alternatives to the current standard visceral leishmaniasis treatment in Brazil
current phase of drug development
updated 15 Feb 2023
Shorter and safer visceral leishmaniasis first-line treatment for people in the Americas
More accessible treatment recommended by PAHO
Until recently, first-line treatment recommendations for visceral leishmaniasis in Brazil included 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 the standard, antimonial-based treatment. The collaborative study was sponsored by the Brazilian Ministry of Health and coordinated by the University of Brasilia, the Oswaldo Cruz Foundation of Brazil, and DNDi. Results showed that due to lower toxicity and acceptable efficacy, liposomal amphotericin B was a more suitable first-line treatment for visceral leishmaniasis than standard treatment. This treatment is more accessible for people because of its shorter duration, fewer side effects and reduced hospitalization time.
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.
In June 2022, the Pan American Health Organization (PAHO) published new guidelines recommending liposomal amphotericin B instead of pentavalent antimonials.
- Indication: Visceral leishmaniasis in the Americas
- Dosage: Liposomal amphotericin B given intravenously for 7 days
- Changed the recommendation of first-line treatment for visceral leishmaniasis in PAHO’s guidelines replacing the antimonial-based treatment by liposomal amphotericin B, a shorter and safer treatment.
- The PAHO guidelines can help national programmes strengthen and expand diagnosis and treatment for people affected by this neglected disease.
‘The Ministries of Health, through their respective technical areas and with the support of local experts, should revise the recommendations in the national context and determine the possibility of incorporating, guaranteeing and expanding patient access to treatment of leishmaniasis using safer and shorter-term therapeutic alternatives.’
Ana Nilce Silveira Maia-Elkhoury, Regional Advisor for Leishmaniasis, PAHO/WHO
The Pan American Health Organization published new guidelines for the treatment of visceral leishmaniasis in the Americas in June 2022, effectively ending treatment with pentavalent antimonials in favour of less toxic drugs. The new guidelines recommend liposomal amphotericin B as first-line treatment for the disease.
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 liposomal amphotericin B will be adopted in the new guidelines.
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.
The Brazilian Ministry of Health is still reviewing its treatment policy to consider the adoption of liposomal amphotericin B as the country’s first-line visceral leishmaniasis treatment.
The Brazilian Ministry of Health is reviewing its policy with regard to the adoption of liposomal amphotericin B 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.
News & resources
- 10 October 2022 - The world versus leishmaniasis, The Medicine Maker
- 29 June 2022 - DNDi welcomes new PAHO recommendations for the treatment of leishmaniasis in the Americas
- 4 July 2017 - Efficacy and safety of available treatments for visceral leishmaniasis in Brazil: A multicenter, randomized, open label trial, PLOS Neglected Tropical Diseases
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