Major study confirms tolerability and high efficacy of 4 gold-standard malaria medicines, when used for repeated treatment over a 2 year period

Major study confirms tolerability and high efficacy of 4 gold-standard malaria medicines, when used for repeated treatment over a 2 year period

The Lancet today published the findings of a large, randomized, multicentre, open-label, longitudinal study of four artemisinin combination therapies (ACTs) in children and adults with uncomplicated malaria in Mali, Burkina Faso and Guinea. The two most recently-approved ACTs, developed by MMV and partners, pyronaridine-artesunate (PA, Pyramax®, Shin Poong) and dihydroartemisinin-piperaquine (DHA-PQP, Eurartesim®, Alfasigma), have been shown to be as efficacious for malaria treatment and retreatment as the current first-line ACTs in those countries, artemether-lumefantrine (AL, Coartem®, Novartis) and artesunate-amodiaquine (ASAQ Winthrop®, Sanofi). The study concludes that greater access to these efficacious treatments in West Africa is justified.

The phase IIIb/IV clinical study was conducted by West African Network for Clinical Trials of Antimalarial Drugs (WANECAM) and coordinated by Prof. Abdoulaye Djimde, University of Science, Techniques and Technologies of Bamako, Mali. MMV provided financial, scientific and operational support, and the European & Developing Countries Clinical Trials Partnership provided additional funding.

More than 4,700 patients from seven centres in Burkina Faso, Guinea and Mali were randomized and treated with the same antimalarial each time they had a new malaria episode, over a 2-year period. More than 8,500 episodes of malaria were treated, with individual children suffering up to 13 episodes during the study period, highlighting the incredibly high burden of the disease in West Africa.

All four treatment regimens were highly efficacious and well tolerated in repeated treatment over 2 years. DHA-PQP demonstrated a greater degree of post-treatment protective efficacy than ASAQ and AL, meaning that patients treated with this medicine were less likely to be re-infected after treatment. The same difference in post-treatment protective efficacy was observed between PA and AL, but not between PA and ASAQ. The differences can be partly explained by the length of the half-life of the partner drugs (i.e. the time they remain active in the body).

 “The WANECAM study provides a wealth of data on the real-life use of currently available ACTs and their retreatment,” said Dr David Reddy, MMV’s CEO. “Reassuringly, it demonstrated all the ACTs are highly efficacious in treating uncomplicated P. falciparum malaria, which underscores the importance of protecting these highly effective drugs from resistance. Improving access to a broader range of efficacious ACTs is one way to do that. We are proud to have been involved in this study and will continue to work with our partners to increase access to these important medicines.”

“Thanks to this major study, we have been able to demonstrate that a new ACT, Pyramax, is well tolerated even for repeat use,” said Prof. Abdoulaye Djimde. “This means we now have a new tool for the treatment of children in sub-Saharan African who experience multiple episodes of malaria every year. WANECAM is proud to have contributed to broadening the choices of ACTs for Africa.”

“The work of the West African Network for Clinical Trials of Antimalarial Drugs (WANECAM) is a resounding exemplar of the value and need of international research collaboration to address global societal problems such as malaria, TB, HIV and anti-microbial resistance. Collaborative research between North and South, between public and private parties delivers high-quality results and much needed African research capacity in the fight against poverty-related infectious diseases.” Dr Michael Makanga, EDCTP Executive Director.