Artemisinin-based combination therapies (ACTs) are the current WHO-recommended standard of care for uncomplicated malaria. In 2011 and 2012, two new ACTs, Eurartesim and Pyramax, were approved by stringent regulatory authorities. To help gather evidence to guide the optimal and widespread use of these new ACTs, MMV has been working with partners to study how they fare in the real world. First, MMV and Sigma-Tau provided Eurartesim for the INESS1 Phase IV platform to gather safety and effectiveness data. Second, with the support of EDCTP,2 MMV is working with WANECAM3 on a longitudinal Phase IIIB/IV trial in Mali, Burkina Faso and Guinea comparing the safety and efficacy of repeated use of Eurartesim and Pyramax with that of currently used ACTs in the region [artemether-lumefantrine (AL) or artesunate-amodiaquine (ASAQ)].
Prof. Abdoulaye Djimde University of Science, Techniques and Technologies of Bamako, Mali, talks about the WANECAM trial and what it has revealed so far.
1. How is the WANECAM trial progressing and what has it revealed so far about currently available antimalarials?
The trial began in 2009 and completed patient recruitment just ahead of schedule in mid December 2013, with 4722 patients from seven centres in Mali, Burkina Faso and Guinea. We were able to achieve this huge milestone thanks to the hard work of the team. All patients will now be followed for 2 years. On average, each patient is expected to have three episodes of malaria, so by the end of the trial we will have data on more than 1200 cases of malaria. It’s a huge trial, one of the largest ever of antimalarials.
So far, we have obtained enough data points to be able to assess whether Pyramax is as well tolerated for repeat treatments as it is for the first. The final analysis is pending, but the preliminary data is encouraging. The trial also looks at the real-life safety of Eurartesim. Interim analyses are planned once 50% of the patients have reached the 2-year follow-up mark.
2. In addition to the scientific findings, what else have you learnt through working with WANECAM and conducting the trials?
It has been a tremendous learning experience on a number of levels. It’s the first time our university has taken on the responsibility of trial sponsor. We already knew the rules of the game as principal investigators (PIs) but being a sponsor is something else entirely. You are ultimately responsible for the trial, dealing with severe adverse events and reporting them to various regulatory authorities and deciding whether the trial should continue. In addition to the main funding from EDCTP, it has been fantastic to have the backing of the MMV team, not just in terms of finance. The funding is good, but the technical expertise and experience of running trials has really helped us to get to where we are. I don’t know if we would have been able to pull it off on our own.
3. What’s next after this study has been completed?
Today, WANECAM is a really solid network. Each of the various teams operates as if we were one large team. We all know each other very well, the PIs, clinical coordinators, scientists, pharmacists, even the drivers. We are now ready to put ourselves on the market for similar trials, which I think are going to become increasingly necessary as we move towards malaria elimination and eradication.
1. INESS: INDEPTH Effectiveness and Safety Studies of Antimalarial drugs in Africa.
2 EDCTP: European and Developing Countries Clinical Trials Partnership.
3. WANECAM: West African Network for Clinical Trials of Antimalarial Drugs.