New Delhi, Jan 12 (NationPress) A fixed-dose combination of albendazole and ivermectin could be a more effective strategy against soil-transmitted helminths responsible for intestinal infections, as revealed by a phase II-III clinical trial.
Four types of parasitic worms—Ascaris lumbricoides, Trichuris trichiura, and the hookworms Ancylostoma duodenale and Necator americanus—are the primary culprits of soil-transmitted helminthiases (STH). These worms spread through contact with contaminated soil or water, significantly affecting nutrition and health, especially in children and women of reproductive age.
The findings from this randomized clinical trial, published in The Lancet Infectious Diseases, could assist endemic countries in achieving the control objectives laid out in the WHO's 2021-2030 Roadmap for Neglected Tropical Diseases.
“Current treatments for soil-transmitted helminthiases face hurdles, particularly in targeting Trichuris trichiura. Combination therapies, especially with ivermectin and albendazole, show promise,” stated the international research team led by the Barcelona Institute of Global Health (ISGlobal) in Spain.
The study aimed to evaluate the safety, effectiveness, and palatability of a combination tablet for treating T trichiura, hookworm, and Strongyloides stercoralis infections among school-aged children in the African countries of Ethiopia, Kenya, and Mozambique.
The existing approach to combat these infections includes regular deworming with albendazole for at-risk populations, coupled with improvements in water, sanitation, and hygiene.
Although albendazole is highly effective against Ascaris, its effectiveness against T. trichiura has been waning, potentially due to emerging drug resistance. Additionally, albendazole does not work against Strongyloides stercoralis.
Between January 2022 and March 2023, the research team recruited 1,001 participants (46% female and 54% male).
Approximately 64% were infected with T trichiura, 36% with hookworm, and 10% with S stercoralis. Nine percent of the 1,001 participants had co-infections and were considered in the analysis of each infecting species.
A total of 243 participants were assigned to the albendazole group, 381 to a single dose of a fixed-dose combination (FDC×1) of albendazole (400 mg) plus ivermectin (9 mg or 18 mg), and 377 to three consecutive daily doses (FDC×3) of albendazole (400 mg) plus ivermectin (9 mg or 18 mg).
In both phase 2 and 3 trials, gastrointestinal symptoms were the most frequently reported mild-to-moderate adverse events in the FDC groups but resolved within 48 hours without treatment.
For T trichiura, both FDC groups demonstrated a higher cure rate (97.2% for FDC×3 and 82.9% for FDC×1) compared to albendazole (35.9%).
For hookworms, FDC×3 showed a higher cure rate (95.0%) than albendazole alone (65.1%), while FDC×1 had a similar cure rate (79.8%) to albendazole. The sample size for evaluating the efficacy of S stercoralis was not met, the researchers noted.
“An FDC of albendazole and ivermectin has a comparable safety profile but superior efficacy compared to albendazole alone against T trichiura infection and hookworms. These results create avenues for controlling all soil-transmitted helminth species of interest, including potentially S stercoralis,” stated the team, advocating for further research in larger populations to assess the safety of this drug regimen.
