A study presented at the 63rd annual meeting of the American Society of Tropical Medicine and Hygiene (ASMTH) used polymerase chain reaction (PCR) to show that artesunate-mefloquine fixed-dose combination (ASMQ FDC) is as safe and effective as the African standard of care in treating malaria in children in Africa.
Malaria is one of the biggest killers in Africa, and caused between 473,000 and 789,000 deaths in Africa in 2012, mostly in African children. The World Health Organisation (WHO) recommends the use of artemisinin-based combination therapies (ACTs) in uncomplicated Plasmodium falciparum malaria. Combinations of artesunate and mefloquine have been used wide in Asia and Latin America, but little in Africa. The fixed dose combination used in this study, a two-in-one once-daily treatment to make sure the drugs are always taken in the right proportions, was developed through the FACT Project Consortium and launched in 2008. The consortium includes academic and industry partners from Asia, Africa, South America and Europe, under the umbrella of the Drugs for Neglected Diseases initiative (DNDi).
The aim of the phase IV study was to assess the safety and efficacy of ASMQ, comparing it with artemether-lumefantrine (AL), the most widely used treatment in Africa, in children under five from Burkina Faso, Kenya and Tanzania. The children, who were feverish and had P falciparum density of 2,000-200,000 parasites/µl, were dosed with ASMQ or AL for 3 days according to age, and followed for 60 days. If patients still had parasites in their blood after follow-up, they were switched to the other treatment.
Using WHO efficacy analysis parameters that ASMQ was as effective as AL at the three time points tested (day 28, day 42 and day 63), and that there were no tolerability issues or unexpected adverse effects events with either regimen. According to the researchers, these results suggest that ASMQ should be added into Africa’s current malaria treatment arsenal.
This study was one of a number recommended by the WHO and its prequalification programme, as part of an aim to delay the emergence of resistance to the individual drug components of the combination treatment. This formulation, a single tablet given once daily over three days (compared with twice-a-day over three days for AL), couple improve compliance and therefore reduce resistance.
“The ASMQ fixed-dose combination has proven its importance among tools recommended by the WHO and can now be available to African children suffering from uncomplicated falciparum malaria,” said Dr Bernard Pécoul, Executive Director of DNDi. “Considering that a child dies every 30 seconds from malaria, we hope that governments in affected African countries will now take up this additional treatment option to ensure their populations have access to several ACTs.”
This product, packaged to offer an three-year shelf life, the longest for malaria fixed-dose combinations to date, was registered in Brazil in 2008, and has since been approved in India, Malaysia, Myanmar, Tanzania, Vietnam and Niger. The agent has been submitted for approval in 17 more countries, and further launches are planned across Latin America, Southeast Asia and Africa. It was pre-qualified by the WHO Prequalification Programme in 2012.