Tafenoquine, a single-dose therapy for Plasmodium vivax malaria, has been associated with relapse prevention through the clearance of P. vivax parasitemia and hypnozoites, termed “radical cure.”
Treatment of Plasmodium vivax malaria requires the clearing of asexual parasites, but relapse can be prevented only if dormant hypnozoites are cleared from the liver (a treatment termed “radical cure”). Tafenoquine is a single-dose 8-aminoquinoline that has recently been registered for the radical cure of P. vivax.
Half the world’s population lives at risk of the Plasmodium vivax malaria parasite. Once it has infected the human body, it can lie dormant in the liver, hidden from standard antimalarial medicines, and reawaken at regular intervals causing a malaria bouts in the absence of a mosquito bite.
GSK and Medicines for Malaria Venture (MMV) today announced the publication of positive results from two phase III studies of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in The New England Journal of Medicine.
So far, most medicines for malaria target the pathogenic blood stages and treat the symptoms of the disease. This makes sense. It’s imperative to deal with the immediate suffering of a patient before looking at how to prevent future suffering. Yet, if malaria is to be eradicated, a broader range of medicines with different profiles is needed, not least medicines that can stop the relapse of malaria caused by the Plasmodium vivax parasite.
GSK and Medicines for Malaria Venture (MMV) today announced that the Australian Therapeutic Goods Administration (TGA) has approved single-dose Kozenis (tafenoquine) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for the acute P. vivax infection.
A Marketing Authorization Application for tafenoquine for radical cure (prevention of relapse) of P. vivax malaria has been submitted by GSK to the Brazilian Health Regulatory Agency (ANVISA) under a priority review, making Brazil the first malaria-endemic country to evaluate the new single dose anti-relapse medicine. A priority review has been granted.
Currently, primaquine is the only treatment available to prevent the relapse of Plasmodium vivax malaria. However, as per the primaquine label and WHO recommendations, it is administered once daily for 14 days – a regimen that is hard for patients to comply with, meaning that many are not cured. A single-dose treatment with the potential to improve patient compliance would positively impact P. vivax control and elimination efforts.