New tablet shows promise for the control and elimination of intestinal worms
The results from the ALIVE trial led by the EDCTP-funded STOP Consortium showed that a tablet combining albendazole and ivermectin is safe and more effective than albendazole alone in treating soil-transmitted helminths. The results, published in The Lancet Infectious Diseases on 10 January 2025, offer opportunities to improve the control of these neglected tropical infections, which affect around 1.5 billion people worldwide.
“EDCTP congratulates the STOP consortium on the publication of the ALIVE trial results, which represent a major step forward in providing safe and effective treatment to the millions of people affected by helminth infections. ”
Dr Pauline Beattie, Operations Manager and Scientific Adviser, EDCTP Association
An estimated quarter of the world’s population is infected with soil-transmitted helminths, a group of parasitic worms transmitted via contaminated soil. The standard treatment for these infections is albendazole, but this drug is not effective against all species of helminth and there is growing evidence of parasite resistance (as reported by the EDCTP-funded PROFORMA consortium in Ethiopia).
A greater breadth of protection could come from combining albendazole with a second drug, ivermectin. In the phase II/III ALIVE trial in Ethiopia, Kenya and Mozambique, the STOP consortium tested the efficacy of a fixed-dose combination of ivermectin and albendazole for the treatment of soil-transmitted helminths in nearly 4000 children. Ivermectin has been shown to be more effective against T. trichiura when combined with albendazole, and is the drug of choice to treat S. stercoralis and other parasitic infections. The findings formed part of a submission made to the European Medicines Agency (EMA) in 2023 for a scientific opinion on the fixed-dose combination of ivermectin and albendazole.
The Consortium’s work has also been supported by the UK Medical Research Council via a Participating States Initiated Activity (PSIA). The PSIA funding enabled the project team to respond to scientific advice received from the EMA to conduct a preparatory study to demonstrate that the two drugs given together have broadly the same activity as when given separately (a bioequivalence study) as well as a phase II safety trial in Kenya as a prelude to the main ALIVE trial. The ALIVE trial also received cofunding from Mundo Sano and the UK Foreign & Commonwealth Office.
Further development of the new fixed-dose combination will take place through the STOP2030 project, funded through the Global Health EDCTP3 programme. This project is testing the safety and effectiveness of the fixed-dose combination in mass drug administration campaigns in Kenya and Ghana.