Viewpoint by
Dr Bernhards Ogutu, KEMRI, Kenya and Dr Sodiomon Sirima, CNRFP, Burkina Faso
Today, we have results of a large clinical trial conducted in three countries across both East and West Africa by DNDi in partnership with the Central National de Recherche et de Formation sur le Paludisme (CNRFP) in Burkina Faso, the Kenya Medical Research Centre (KEMRI) in Kenya, the National Institute for Medical Research (NIMR), and the Ifakara Health Institute in Tanzania. ASMQ (artesunate-mefloquine) fixed dose combination (FDC) has proven safe and efficacious in treating children with uncomplicated P. falciparum malaria in Africa, and is non-inferior to artemether-lumefantrine (AL).
ASMQ FDC, recommended and prequalified by the WHO, is given once a day during three days, and this is important in improving patient compliance to treatment. Importantly, increasing the number of treatment options African countries have in their therapeutic arsenals for children < 5 years with uncomplicated malaria is an important means to containing the risk of drug resistance. The positive results of the trial can, furthermore, facilitate the treatment being adopted as part of multi-first-line treatment approaches in African countries.
Malaria is the leading parasitic cause of morbidity and mortality worldwide, with African children under five years of age being the most severely affected. In 2012 alone, the disease killed an estimated 482,000 children: that is 1,300 children every single day. In sub-Saharan Africa – where 90% of all malaria deaths occur – the disease kills one child every minute. In Burkina Faso, 63 % of the deaths among children under 5 years of age are due to malaria. In Kenya, the estimate is 20%.
Despite the reduction of the global malaria mortality rate, developing appropriate health tools, including new treatments, remains the cornerstone of malaria control and will also play a major role in strategies to eliminate the disease altogether. Testing new treatments to ensure they are safe and efficacious, and that they are affordable and can be delivered feasibly through health systems in Africa is crucial.
As with all infections, drug resistance will occur, which is one of the reasons combination therapy has become the treatment mainstay for disease control. In malaria, treatments combine an artemisinin-derivative with another anti-malarial, which we call artemisinin-based combination therapies, or ACTs. ACTs help to achieve ‘rapid kill’ of the parasite while delaying development of resistance to the companion drugs in the combination. ACTs, widely deployed in African countries, are the backbone of the malaria treatment arsenal and have been recommended by the World Health Organization (WHO) as the first line medication against uncomplicated malaria for the past decade.
In African countries, there are currently three (of the four recommended) WHO prequalified ACTs used as first-line treatments, and a number of producers: artemether-Lumefantrine (AL), artesunate-amodiaquine (ASAQ), and dihydroartemisinin-piperaquine (DHA-PQP). African countries are keen on bringing new, affordable ACTs to their populations especially within the paradigm of multiple first-line treatments and targeting asymptomatic cases. Today we need to rapidly introduce all WHO recommended ACT FDCs that are now ready for introduction in Africa. ASMQ FDC was developed in partnership between DNDi and the Brazilian company Farmanghuinos, with technology transfer to the Indian generic manufacturer Cipla. Prior to recent findings, there was insufficient data on its use in African children limiting its adoption as first-line treatment.
This is all good news for Africa. However, we now have to ensure that the registration, implementation and uptake of all WHO recommended and prequalified ACT FDCs occur with no delay in all African countries to effectively tackle malaria. In the end patient access to these treatments is what will truly measure progress.
Dr Bernhards Ogutu, KEMRI, Kenya and Dr Sodiomon Sirima, CNRFP, Burkina Faso
