First real-world use of new protocol for P. vivax case management in Brazil – a Health Ministry and MMV collaboration
Since September this year, patients diagnosed with Plasmodium vivax (P. vivax) malaria in the municipalities of Manaus and Porto Velho in Brazil have been receiving a new treatment protocol as part of an innovative programme led by the Ministry of Health (MoH). The new protocol includes testing for G6PD deficiency before P. vivax radical cure with either single-dose tafenoquine, developed by MMV and GSK, or 7-day primaquine, the current standard of care. It represents the first-ever, large-scale real-world, application of tafenoquine. The adherence to this protocol is evaluated through a study called TRuST led by the Tropical Medicine Foundation of Amazonas (FMT) and the Tropical Medicine Research Center of Rondonia (CEPEM). This study will allow the MoH to determine whether to adopt the protocol nation-wide.
An innovative programme that aims to improve compliance and outcomes
Patients with P. vivax infections in Brazil are currently treated with chloroquine for 3 days and primaquine for 7 days. Under this innovative programme, single-dose tafenoquine, granted marketing authorization in Brazil in 2019, will be available for the first time for adult patients with normal G6PD enzyme activity along with chloroquine for 3 days. This shorter regimen – recommended by the MoH in both municipalities for 1 year – is expected to help improve patient compliance and thereby offers the potential to improve treatment outcomes. Brazil is the first country in the world to engage in large-scale use of this new treatment protocol.
“Since P. vivax infects over 80% of malaria patients in the country and represents a burden to both patients and the public health system, especially in the Amazon region, the possibility of being able to deploy widely this important new tool gives us hope. It could take us one step closer to the elimination of this disease,” said Dr Marcus Lacerda, Director of Research, Tropical Medicine Foundation Dr. Heitor Vieira Dourado (FMT-HVD) and Principal Investigator for TRuST.
Generating data to help guide optimal deployment
This innovative programme has now started in hospitals and by design is intended to expand to primary health care units after a few months based on the results of the study’s interim analysis, ultimately covering all facilities providing malaria treatment in both municipalities.
According to Dr David Reddy, Chief Executive Officer at MMV, “Brazil’s multi-level health system makes it ideal for this work. The country played a pivotal role in the research on the efficacy and safety of tafenoquine and so we are delighted to continue the work with in-country partners to make Brazil the first malaria-endemic country to use the drug on a large scale, generating real-world data to help guide the optimal deployment of tafenoquine and G6PD testing in the national health system.”
→Learn more about the TRuST study from vivaxmalaria.org or download the TRuST study infographic.