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Australian regulators have approved a simple combination of drugs as an effective treatment for one type of malaria in children aged 2 to 16, opening the door to approvals in other countries and heralding a new weapon in the fight against a deadly disease.
The drug is a single dose of tafenoquine (Brand name Kozenis) administered in conjunction with conventional chloroquine therapy. The approval was announced Monday by Medicines for Malaria Venture, a nonprofit that helps develop the drug.
Tafenoquine made by GlaxoSmithKline can treat a type of malaria caused by Plasmodium vivax, most common in South and Southeast Asia, South America and the Horn of Africa.
The drug will be submitted for approval in nine countries and to the World Health Organization, according to George Jagoe, vice president of Malaria Venture.
Malaria is among the deadliest of infectious diseases. There were 229 million new infections in 2019 and 558,000 deaths; The numbers soared during the Covid-19 pandemic, 627,000 deaths in 2020
Most of these deaths in sub-Saharan AfricaIt is home to a species of malarial parasite called Plasmodium falciparum. Most deaths occur in children younger than 5 years old. first malaria vaccinealso made by GlaxoSmithKline against P. falciparum.
P. vivax causes up to five million malaria infections each year; Children aged 2 to 6 years are four times more likely than adults to develop the disease.
The parasite is a slippery enemy that scurries rapidly between different forms in the body. Infection in the blood can cause acute symptoms such as fever, chills, vomiting and muscle aches.
P. vivax may also be stored in the liver and trigger relapses months or even years after initial exposure. These episodes can lead to severe anemia, permanent brain damage, and death.
“This is a trademark of vivax malaria,” said Mr. Jagoe.
Most treatments, including chloroquine, are aimed at the blood stage of the parasite and therefore cannot prevent recurrence of the infection and associated symptoms. However, tafenoquine goes after dormant colonies in the liver. Along with chloroquine, tafenoquine can provide what scientists call “radical therapy.”
In July 2018, the Food and Drug Administration approved 300 milligrams of tafenoquine for the radical treatment of P. vivax malaria in adults and adolescents aged 16 years and older. Drug regulators in Australia, Brazil, Thailand and Peru did the same with similar approvals.
The new formulation for children is supplied as a single small 50 milligram tablet dispersed in water; this is much easier for kids to take than existing seven- or 14-day pills developed for adults – and therefore much more likely to happen. Used.
“Today we have a tool to stop relentless relapse for adults and children alike – we are one step closer to beating this disease,” said David Reddy, CEO of Medicines for Malaria Venture.
Drugs for P. falciparum can be evaluated quickly, but trials require much longer follow-up, as P. vivax causes recurrent malaria. “What you’ve really proven with vivax treatments like this is that you won’t have a relapse six months from now,” said Mr. Jagoe.
Researchers evaluated different doses of the drug by weight for children ages 2 to 15 who weighed at least 22 pounds. Researchers recruited 60 children with P. vivax malaria from three regions in Vietnam and one in Colombia.
All children received a single dose of tafenoquine and one dose of chloroquine administered according to local or national guidelines for the treatment of active blood stage infection.
The researchers reported that about 62 percent of children reported some side effects, a percentage similar to that seen in adults and adolescents. Although the treatment caused vomiting in about one-fifth of the children, none of the side effects were severe.
At four months, the efficacy of treatment in preventing relapse was 95 percent, similar to efficacy in adults and older adolescents.
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