Clinical Trial Shows New Tablet Safe and More Effective for Elimination of Intestinal Worms - Video

A new tablet combining albendazole and ivermectin is safe and more effective than albendazole alone in treating Trichuris trichiura and other soil-transmitted helminths (STH), according to a clinical trial conducted by the STOP consortium. The findings, published in The Lancet Infectious Diseases, open opportunities to improve the control of these neglected tropical infections, which affect around 1.5 billion people worldwide.

“This fixed-dose co-formulation (FDC) has several advantages. It is easy to administer, as it is one single pill and does not require dose adjustments based on the child’s weight,” explains project leader Jose Muñoz, ISGlobal researcher and Head of the International Health Service at Hospital Clinic Barcelona. “Also, we hope that combining two drugs with different mechanisms of action will reduce the risk of the parasites becoming drug-resistant,” he adds.

The ALIVE clinical trial tested the safety and efficacy of the FDC in school-aged children infected with T. trichiura, hookworms, S. stercoralis or a combination. The children 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 the FDC (FDCx3) over three consecutive days.

Phase 2 of the trial focused on safety. A small number of participants were recruited and treated sequentially according to weight, to monitor 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 proceed to phase 3, where efficacy was assessed in a much larger number of participants, alongside continued safety monitoring. Treatment efficacy was assessed based on cure rates (absence of eggs in stool samples post-treatment) and reduction in the number of eggs in stool compared to before the treatment. Although most infections were classified as light, both FDC regimens achieved higher egg reduction rates than albendazole alone.

Reference: Albendazole–ivermectin co-formulation for the treatment of Trichuris trichiura and other soil-transmitted helminths: a randomised phase 2/3 trial, Krolewiecki, AlejandroKrolewiecki, Alejandro et al. The Lancet Infectious Diseases, Volume 0, Issue 0