Brazil launches ambitious malaria elimination initiative with tafenoquine—a game-changer in combating P. vivax malaria

BRAZIL — In an unprecedented move, Brazil has emerged as a trailblazer in the global fight against malaria by introducing tafenoquine, a groundbreaking single-dose treatment for P. vivax malaria.

Endorsed by the nation’s public health system, this remarkable medical breakthrough marks the first new P. vivax treatment developed in seven decades, signifying a momentous stride in the battle against the disease.

Malaria, a devastating disease that disproportionately affects the impoverished and vulnerable, has been a longstanding barrier to prosperity, trapping communities in a relentless cycle of poverty.

Traditionally, the focus of malaria eradication efforts has been centered on P. falciparum, the more deadly strain prevalent in Africa.

However, the equally formidable P. vivax, notorious for its frequent relapses, requires urgent attention if we aim to expand the list of 41 nations declared malaria-free.

On the momentous date of 5th June, Brazil achieved a momentous milestone by becoming the first country globally to approve the nationwide rollout of tafenoquine, a revolutionary single-dose treatment for P. vivax malaria, through its public health system.

Given the geographical prevalence of P. vivax, particularly in Asia-Pacific, Latin America, and areas near malaria elimination, this approval holds the key to unleash a transformative impact on the global malaria landscape.

Understanding the challenge of P. vivax malaria transmission

At the heart of the battle against P. vivax lies its unique ability to cause recurrent malaria episodes, stemming from just a single infectious mosquito bite.

Furthermore, human-to-human transmission occurs when infected individuals serve as carriers, passing on the parasite when a mosquito feasts on their blood, subsequently transmitting it to family, friends, and neighbors.

To combat these relapses effectively, a comprehensive “radical cure” approach is essential. This involves treating both the blood- and liver-stages of the P. vivax infection, a task that has presented considerable challenges in the past.

In the past, radical cure treatment involved a lengthy process, with chloroquine for three days to treat the blood-stage and primaquine for seven or 14 days to address the liver-stage infection.

Unfortunately, treatment adherence issues were rampant, as many patients failed to complete the full course, leading to relapses that perpetuated P. vivax malaria transmission.

However, with the advent of tafenoquine, this bleak narrative is set to change. Extensive research conducted by GSK and MMV, with pivotal contributions from researchers in Manaus and Porto Velho between 2014 and 2016, led to the development of this groundbreaking single-dose treatment.

As a result, the long-awaited solution to tackle P. vivax malaria was finally at hand.

The groundbreaking efforts in Brazil extended beyond tafenoquine’s development. Simultaneously, researchers also spearheaded critical studies on a cutting-edge point-of-care test to detect glucose-6-phosphate-dehydrogenase (G6PD) deficiency.

This condition, affecting around 5% of Brazil’s population, can lead to hemolytic anemia in individuals taking primaquine or tafenoquine.

The introduction of the G6PD test revolutionized the diagnostic landscape, enabling rapid and accurate detection of the condition, ensuring that treatment plans could be tailored accordingly.

Recognizing the potential of these advancements, Brazil’s Ministry of Health embraced the opportunity to harness them in turbocharging the nation’s malaria elimination efforts.

With the official approval and registration of tafenoquine in Brazil in 2019, the nation wasted no time in initiating real-world studies to explore the drug’s practical applications in Manaus and Porto Velho.

The aim was to assess the feasibility of conducting quantitative point-of-care G6PD tests at various levels of the extensive malaria services network within the public system.

The results of these studies would pave the way for a robust and comprehensive strategy to combat P. vivax malaria nationwide.

First real-world study shows promising results

In a leap towards eradicating malaria, Brazil’s Ministry of Health (MoH) and Medicines for Malaria Venture (MMV) launched the groundbreaking real-world study, TRuST, in September 2021.

The study’s aim was to assess the feasibility of implementing tafenoquine and G6PD testing across 43 health facilities in Manaus and Porto Velho, with astounding results.

With meticulous planning and the cooperation of municipal and state-level health authorities, tafenoquine and G6PD testing were introduced into the Brazilian health system.

An impressive compliance rate of over 99% was achieved, demonstrating that routine G6PD testing for appropriate radical cure was attainable nationwide.

Following the study’s conclusion in August 2022, a comprehensive dossier was submitted to CONITEC, the country’s health technology assessment body, which recommended the integration of these new tools into the public health system.

As a result, on 5th June, Brazil became the first malaria-endemic country to adopt single-dose tafenoquine and quantitative point-of-care G6PD testing throughout its healthcare network.

Regional impact and global implications

Brazil’s success has far-reaching implications for neighboring countries and beyond. Inspired by Brazil’s achievements, Peru, Thailand, Vietnam, and Ethiopia are embarking on their own tafenoquine and G6PD testing feasibility studies, supported by organizations like Unitaid, MMV, and PATH.

With data from these emerging studies, the World Health Organization (WHO) guidelines and national malaria programs worldwide can be optimized to bolster efforts in controlling and eliminating P. vivax.

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