1. Why was it important to study Pyramax as part of the CANTAM real-life study?
In previous randomized controlled clinical trials, pyronaridine-artesunate showed high efficacy and an acceptable safety profile for the treatment of acute uncomplicated P. falciparum malaria. However, in some patients, we observed mild to moderate increases in liver enzymes. The CANTAM study was therefore carried out to assess the hepatic safety, tolerability and effectiveness of pyronaridine-artesunate in adults and children in real-life conditions in Africa, including in patients with elevated baseline liver enzymes.
2. Why is Pyramax an important addition to the malaria toolbox?
Pyramax is the only ACT with stringent regulatory approval for the treatment of both P. falciparum and P. vivax malaria. In addition, the CANTAM study showed it to be well tolerated and efficacious in African patients under conditions similar to real-life clinical practice in Africa. This makes it an important addition to the malaria toolbox.
3. Why do we need multiple ACTs and what does this mean in the context of emerging partial drug resistance to artemisinin derivatives in Africa?
One major challenge being faced in malaria case management is the spread of drug resistance in Plasmodium parasites. Partial resistance to artemisinin has been recently reported in Africa and is causing some concern. Resistance is caused by several factors, including overuse of drugs for prophylaxis, incomplete therapeutic treatment of patients and the parasite’s adaptability to drugs. Use of multiple ACTs will not only help reduce the number of clinical cases and treatment failures but may also significantly delay the occurrence of resistance.
4. How important were the Community Health Workers (CHWs) in the success of this study?
The role of CHWs in the CANTAM study was vital and their commitment praiseworthy. They visited the patients on Day 7 and Day 28, following recruitment on Day Zero, and were the principal link between the recruitment facility and patient follow-up at home. They closely followed up and monitored patients in the community, ensured compliance with the treatment guidelines and reported adverse events that might or might not have been related to the pyronaridine-artesunate treatment.
5. Has participation in this major real-life study changed the management of malaria in Congo?
The CANTAM study significantly changed the management of malaria – last year, pyronaridine-artesunate was included in the Congolese national treatment guidelines (NTGs), meaning it is now listed in the NTGs of four out of five participating countries (together with Democratic Republic of Congo, Cameroon and Côte d’Ivoire).
6. What has it been like to work with MMV on this project?
As a partner, MMV was accountable to stakeholders and diligently oversaw the continuous monitoring of activities. This allowed quick adjustments to the project when required. The experience has empowered the team with different skill sets for future networking and possible clinical trials.