United Nations new tabletthat combines albendazole and ivermectinis safe and more effective than an albendazole-only tablet in the treatment of Trichuris trichiura and other soil-transmitted helminths (STH), according to a clinical trial carried out by the STOP consortium and led by the Barcelona Institute for Global Health (ISGlobal), a center promoted by the “la Caixa” Foundation. The findings, published in The Lancet Infectious DiseasesThey open opportunities to improve the control of these neglected tropical infections, which affect an estimated 1.5 billion people worldwide.
The soil-transmitted helminthiasis (STH) are caused by four species of parasitic worms –Ascaris lumbricoides, Trichuris trichiura and hookworms Duodenal ancylostoma and American Necator– which are transmitted through contact with contaminated soil or water. They have a significant impact on nutrition and healthespecially in the child population and women of reproductive age living in endemic areas of Latin America, Asia and sub-Saharan Africa.
The current strategy for the control of helminths is based on regular albendazole treatments for at-risk populationsalong with improvements in water, sanitation and hygiene. Albendazole is very effective against roundwormsbut its effectiveness against Trichuris trichiura has been decreasing, probably due to the emergence of resistance to the drug. Furthermore, albendazole is not effective against Strongyloides stercoralisanother helminth that has been added to the list of intestinal parasites that require control measures.
Two medicines in one tablet
Therefore, the STOP consortiumfunded by the EDCTP, probably a innovative pill that combines a fixed dose of albendazole and ivermectin. 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.
«This fixed dose coformulation (FDC) presents several advantages. It is easy to administer, since it is a single tablet and does not require dose adjustments based on the child’s weight,» explains the project leader, José Muñoz, researcher at ISGlobal and head of the Department of International Health at the Hospital Clínic Barcelona. . . «In addition, we hope that the combination of two drugs with different mechanisms of action reduce the risk of parasites becoming resistant to drugs”, he adds.
A clinical trial in three African countries.
he ALIVE clinical trialmade in Ethiopia, Kenya and Mozambiquetested the safety and effectiveness of FDC in schoolgirls and boys (aged 5 to 18 years) infected with T. trichiurahookworms, S. stercoralis or a combination. Participants were randomly divided into three treatment groups: group 1 received a single dose of albendazole; group 2 received one dose of the FDC (FDCx1); and group 3 received three doses of FDC (FDCx3) for three consecutive days.
First, safety
The phase 2 of the essay focuses on the security. A small number of participants were recruited and treated sequentially according to their weight to monitor for any adverse effects caused by higher than usual doses of ivermectin (above 200 µg/ml). No serious adverse effects were observed and side effects were similar to those in the albendazole group. This allowed the trial to move to phase 3in which the effectiveness in a much larger number of participants, and safety continued to be monitored.
In total, they examined 4,353 children for helminth infections and 1,001 were randomly assigned to treatment. Of those infected, 63% tested positive for T. trichiura36% for hookworms and 10% for S. stercoralis.
Greater effectiveness against T. trichiura and hookworms
The effectiveness of the treatment was evaluated based on the cure rate (absence of eggs in stool samples after treatment) and the reduction in the number of eggs in fecescompared to before treatment. Paraca T. trichiuracoformulation achieved higher cure rates in both regimens (97% for FDCx3, 83% for FDCx1) compared to albendazole alone (36%). For hookworms, the FDCx3 regimen showed a higher cure rate (95%), while the FDCx1 regimen was similar to albendazole (79% and 65% respectively). Paraca S. stercoralisThe sample size was too small to assess efficacy, but evidence suggests that FDC would also be more effective, as ivermectin is much more effective than albendazole against this parasite.
Although most infections were classified as mild, both coformulation regimens achieved higher egg reduction rates than albendazole alone.
Implications for public health
“This is a fundamental test, which opens the possibility of controlling all STH speciesincluding the strongyloidsand you can make it reconsider elimination targets that were considered unattainable with albendazole alone,” he says. Alejandro Krolewieckileader of the clinical trial. The next step is to carry out larger trials, such as the one led by the project. STOP2030to evaluate the safety of FDC in the context of mass deworming campaigns.
It will also be essential define optimal implementation strategies for national programs to adopt FDC. The trial results suggest that a single-dose regimen may be simple to implement in mass deworming activities, while the three-day regimen, which offers superior efficacy, may be better for individual treatment, or for programs that aim to eliminate by complete the STH of the population.
“Thanks to your formula adapted to the children’s population – orodispersible and with mango flavor – and its great acceptance, this tablet has a great potential to improve health in the regions affected by these diseases,” says Stella Kefaresearcher at the Kenya Medical Research Institute (KEMRI).
Reference
Krolewiecki A, Kepha S, Fleitas PE et al. Coformulation of albendazole and ivermectin for the treatment of Trichuris trichiura and other soil-transmitted helminths: a randomized phase 2/3 trial.The Lancet Infectious Diseases. https://doi.org/10.1016/S1473-
financier
The STOP project has been supported by the EDCTP2 program (grant number RIA2017NCT-1845 and PSIA2020-3072) www.stoptheworm.org
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