Patients over 16 years of age from all over the country will have access, through the SUS (Unified Health System), to the drug tafenoquine, used against malaria, specifically in the fight against the form caused by Plasmodium vivax. The great advantage is the use in a single dose.
The ordinance of the Secretariat of Science, Technology, Innovation and Health Complex of the Ministry of Health on the subject was published this Tuesday (6) in the Official Gazette of the Union. Incorporation into the SUS must take place within 180 days.
The commonly used drug is primaquine, administered for seven consecutive days, during which time there is an improvement in symptoms (such as pain and fever) and, as a result, treatment is often abandoned, despite the fact that the parasites remain in the body.
Thus, incomplete treatments are an obstacle to the control and eventual elimination of malaria in Brazil, allowing relapses and new transmissions.
The use of tafenoquine, however, is conditioned to the dosage of an enzyme known as G6PD (glucose-6-phosphate dehydrogenase). If G6PD levels are low, treatment with drugs from the tafenoquine and primaquine class can lead to consequences such as hemolysis (destruction of red blood cells) and severe anemia. About 5% of the Brazilian population has G6PD deficiency.
The treatment of the acute phase of malaria also includes chloroquine, a drug widely used, without scientific support, in the Covid-19 pandemic.
O P. vivax is responsible for a relatively milder manifestation of malaria compared to P.falciparum, the main cause of deaths from the parasitosis in the world. Still, the P. vivax is responsible for great suffering and economic and social damage to the Brazilian population, with a concentration of cases in the Amazon region, where there is greater transmission of parasites by anopheline mosquitoes, the vectors of the disease. In 2021, 139 thousand cases of malaria were diagnosed in the country, 80% of them caused by P. vivax.
Among the studies that supported the decision to incorporate the drug is the Trust (from Tafenoquine Roll-oUt STudy), which seeks a radical cure for malaria, the elimination of the parasite from both the blood and the liver, with the use of a combination of tafenoquine and test from the G6PD.
The Trust was co-sponsored by the Ministry of Health and MMV (Medicines for Malaria Venture) and led by researchers from the Dr. Heitor Vieira Dourado and the Center for Research in Tropical Medicine of Rondônia (Cepem), respectively in the municipalities of Manaus (AM) and Porto Velho (RO).
“The incorporation of this new treatment into the SUS is the result of a long research process that generated robust scientific evidence, which supported the decision of the Ministry of Health. Thousands of patients benefited from this treatment in the pilot phase, and now the population of endemic areas will being able to have access to a safe treatment, in a single dose. This incorporation represents a watershed for improving adherence to treatment, especially among the most vulnerable”, says Dhelio Pereira, a doctor at Cepem and one of the leaders of the Trust.
Conitec (National Commission for the Incorporation of Technologies in the Unified Health System) also considered a qualitative study carried out with patients and health professionals and a cost-effectiveness and budget impact analysis.
“The National Malaria Program in Brazil is currently focused on eliminating malaria, an ambitious goal for which innovation is fundamental. The incorporation of this innovation into the Unified Health System will provide patients with vivax malaria with a safer and shorter treatment , especially benefiting the population living in remote areas of the Amazon region”, says Ethel Maciel, Secretary of Health and Environment Surveillance at the Ministry of Health, in a press release.
The G6PD diagnostic test is the result of a partnership between the NGO Path and the Korean company SD Biosensor. Tafenoquine, produced by the pharmaceutical company GSK, had its development supported by MMV, which has the support of governments and other entities, such as USAid and the Bill and Melinda Gates Foundation.