New Delhi, Jan 12 A fixed-dose combination of albendazole and ivermectin may be a better tool against soil-transmitted helminths, that cause intestinal infections, according to results of phase II-III clinical trial.
Four species of parasitic worms (Ascaris lumbricoides, Trichuris trichiura, and the hookworms Ancylostoma duodenale and Necator americanus) are responsible for soil-transmitted helminthiases (STH). These parasitic worms get transmitted via contact with contaminated soil or water, causing a significant impact on nutrition and health, particularly in children and women of reproductive age.
The results of the randomised clinical trial, published in the journal The Lancet Infectious Diseases, may help endemic countries reach the control goals set in WHO's 2021-2030 Roadmap for Neglected Tropical Diseases.
“Treatments for soil-transmitted helminthiases face challenges, especially in addressing Trichuris trichiura. Combination regimens, particularly of ivermectin and albendazole, are promising,” said the international team of researchers led by the Barcelona Institute of Global Health (ISGlobal) in Spain.
The study aimed to assess the safety, efficacy, and palatability of a combination tablet for the treatment of T trichiura, hookworm, and Strongyloides stercoralis infections among school-aged children in the African nations Ethiopia, Kenya, and Mozambique.
The current strategy against these infections include regular deworming treatments with albendazole for at-risk populations, along with improvements in water, sanitation, and hygiene.
While albendazole is highly efficient against Ascaris but its efficacy against T. trichiura has been declining, probably due to emerging drug resistance. Albendazole is also not effective against Strongyloides stercoralis.
Between January 2022, and March 2023, the team recruited 1,001 participants (46 per cent were female and 54 per cent were male).
About 64 per cent were infected with T trichiura, 36 per cent with hookworm, and 10 per cent with S stercoralis. Nine per cent of the 1,001 participants had co-infections and were included in the analysis of each infecting species.
A total of 243 participants were allocated to the albendazole group, 381 to the single dose of a fixed-dose combination (FDC×1) of albendazole (400 mg) plus ivermectin (9 mg or 18 mg), and 377 to the 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 common mild-to-moderate adverse events in the FDC groups but resolved within 48 hours without intervention.
For T trichiura, both FDC groups had a higher cure rate (97·2 per cent for FDC×3 and 82·9 per cent for FDC×1) than albendazole (35·9 per cent).
For hookworms, FDC×3 had a higher cure rate (95·0 per cent than albendazole alone (65·1 per cent), whereas FDC×1 had a similar cure rate (79·8 per cent to albendazole). The sample size for efficacy evaluation of S stercoralis was not met, the researchers said.
“An FDC of albendazole plus ivermectin has a similar safety profile but superior efficacy to albendazole alone against T trichiura infection and hookworms. These findings open opportunities for control of all soil-transmitted helminth species of interest, including potentially S stercoralis,” said the team, calling for further studies in larger populations for evaluation of safety of the drug regimen.
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