Brazil becomes the first malaria-endemic country to adopt single-dose tafenoquine and STANDARD G6PD Test for the treatment of relapsing Plasmodium vivax malaria
MMV and PATH are excited to announce that Brazil has become the first malaria-endemic country to incorporate the STANDARD™ G6PD Test and single-dose tafenoquine1 in the public health system for the treatment of Plasmodium vivax (P. vivax) malaria. These innovative new health technologies provide simple effective radical cure thereby preventing the debilitating relapse of P. vivax malaria.
"The Brazilian National Malaria Program is currently focused on malaria elimination, an ambitious goal for which innovation is key. The incorporation of this new treatment into the public health system will enable vivax malaria patients to access a safer and shorter treatment, that especially benefits the population living in remote areas of the Amazon region", Ethel Maciel, Ministry of Health's Secretary for Health
Surveillance and Environment.
“We are thrilled by the Brazilian government’s decision,” said Dr. David Reddy, CEO of MMV. “Brazil played a key role in the efficacy and safety studies that led to the approval of single-dose tafenoquine for P. vivax relapse prevention, and the first real-world implementation of G6PD testing and tafenoquine. It is great to see the country leading the way with the assessment and adoption of these new health technologies.”
“We are excited that this national adoption policy opens a new horizon to eliminate malaria in Brazil. National rollout of tafenoquine and the G6PD diagnostic test and their integration into patient treatment regimen can lead to healthier lives. We’re grateful for all the contributions of the Ministry of Health, researchers, and the malaria workers in Amazonas and Rondônia that made this moment possible,” said Kammerle Schneider, Chief Programs & Innovation Officer at PATH.
The decision to adopt the tools was based on a review of evidence by CONITEC, the Brazilian Commission of Technology Incorporation in the Public Health System, at the request of the Ministry of Health. This review included evidence on the safety and efficacy; results from the first and second interim analyses of TRuST—the largest real-world study on the use of single-dose tafenoquine and G6PD testing conducted in Brazil in 2021–2022; a qualitative study on patient and health worker perceptions of G6PD testing and single-dose tafenoquine linked to TRuST; a cost-effectiveness analysis and a budget impact analysis. TRuST was co-sponsored by the Brazilian Ministry of Health and MMV and led by Dr. Marcus Lacerda from Dr. Heitor Vieira Dourado Tropical Medicine Foundation (FMT-HVD) and Dr. Dhelio Pereira, Tropical Medicine Research Centre of Rondônia (CEPEM) in the municipalities of Manaus and Porto Velho.
P. vivax malaria is estimated to cause between 4.5 and 5.5 million clinical infections every year.2 The clinical features of P. vivax malaria include fever, chills, vomiting, malaise, headache, muscle pain, and in some cases, can lead to severe malaria and death.3 The disease has considerable economic and social impact, perpetuating cycles of poverty. One of the main challenges to malaria control in Brazil is poor treatment adherence, leading to relapses and continued transmission. Accessing remote populations, notably indigenous communities is another major challenge. The simplicity of these new tools will support Brazil’s malaria elimination goal by improving treatment adherence.
1. Brand name Kozenis. Trademark owned or licensed by GSK.
2. World Health Organization (WHO). World Malaria Report 2022. Geneva; WHO; 2022.
3. Price RN et al. Vivax malaria: neglected and not benign. Am J Trop Med Hyg. 2007;77:79–87.