A single-dose drug to treat a particular form of malaria. It is the new possible weapon against a deadly disease that kills hundreds of thousands of people and children around the world. The Australian regulator has just approved a drug combination that appears to be effective in treating a form of malaria affecting children aged two to 16, paving the way for approval in other countries.
The drug is a single dose of tafenoquine (trade name Kozenis, by GlaxoSmithKline), along with traditional chloroquine treatment. The approval under the age of 16 (above 18, tafenoquine has already been approved by the American FDA) was announced by the non-profit Medicines for Malaria Venture, which participated in the development of the drug.
For tafenoquine, which can cure malaria caused by Plasmodium vivaxmore present in South and Southeast Asia, South America and the Horn of Africa, approval will be sought in nine countries, as well as WHO, according to George Jagoeexecutive vice president of Medicines for Malaria Venture.
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Malaria is one of the deadliest infectious diseases: in the world there have been 229 million new infections and 558 thousand deaths, numbers that increased during the Covid pandemic to 627 thousand deaths in 2020. Most of the deaths occurred in sub -saharan where the most common parasite is the Plasmodium falciparum and it affected children under 5. In October, WHO approved the first vaccine for this parasite, also from GlaxoSmithKline.
Il Plasmodium vivax for its part, it causes more than five million infections a year, children aged 2 to 6 are four times more at risk of contracting the disease. The parasite goes through various cycles and acquires different forms in the organism. In the blood, the infection can cause acute fevers, vomiting, body aches and chills. But it can also hide in the liver, recurring months or even years after the initial exposure. These episodes can result in severe anemia, lasting brain damage, and death.
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Most treatments, including chloroquine, target the stage where the parasite is in the blood and therefore cannot prevent the infection from returning, and its symptoms. But tafenoquine goes further and appears to be able to reach dormant parasites in the liver and – in combination with chloroquine – achieve what scientists call a “radical cure”.
In July 2018, the American FDA approved a treatment with 300 milligrams of tafenoquine for the radical cure of malaria from Plasmodium vivax in adults and adolescents over 16 years. Regulatory agencies in Australia, Brazil, Thailand and Peru have done the same.
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The new formulation for children is a single 50-milligram tablet dissolved in water, which is easier to take than the current 7- or 14-day oral therapy developed for adults, and therefore hopefully will be used extensively.
“Today we have a tool to block the return of the disease in adults and children, which is like saying that we are a little bit closer to defeating the disease,” he explained. David ReddyCEO of Medicines for Malaria Venture.
So long as Plasmodium vivax causes recurrent malaria, studies take much longer. “What we can say today is that six months after treatment for P. vivax we did not have relapses due to illness “, Jagoe specified.
The researchers evaluated different dosages of the drug, based on the weight and age of the children, who weighed at least ten kilos, recruiting 60 children with malaria from P. vivax in three locations in Vietnam and one in Colombia. All children received a single dose of tafenoquine and a course of chloroquine according to guidelines for the treatment of active infection in the blood. About 62 percent of children experienced some side effects, a similar rate to that seen in teenagers and adults. No severe side effects, although the treatment resulted in vomiting in about one in 5 children. After 4 months, the effectiveness of the treatment in preventing reinfection was 95 percent, similar to that in adults and adolescents.