Assessment of Efficacy and Quality of Two Albendazole Brands Commonly Used against Soil-Transmitted Helminth Infections in School Children in Jimma Town, Ethiopia

Abstract

BackgroundThere is a worldwide upscale in mass drug administration (MDA) programs to control the morbidity caused by soil-transmitted helminths (STHs): Ascaris lumbricoides, Trichuris trichiura and hookworm. Although anthelminthic drugs which are used for MDA are supplied by two pharmaceutical companies through donation, there is a wide range of brands available on local markets for which the efficacy against STHs and quality remain poorly explored. In the present study, we evaluated the drug efficacy and quality of two albendazole brands (Bendex and Ovis) available on the local market in Ethiopia.Methodology/Principal FindingsA randomized clinical trial was conducted according to the World Health Organization (WHO) guidelines to assess drug efficacy, by means of egg reduction rate (ERR), of Bendex and Ovis against STH infections in school children in Jimma, Ethiopia. In addition, the chemical and physicochemical quality of the drugs was assessed according to the United States and European Pharmacopoeia, encompassing mass uniformity of the tablets, amount of active compound and dissolution profile. Both drugs were highly efficacious against A. lumbricoides (>97%), but showed poor efficacy against T. trichiura (~20%). For hookworms, Ovis was significantly (p < 0.05) more efficacious compared to Bendex (98.1% vs. 88.7%). Assessment of the physicochemical quality of the drugs revealed a significant difference in dissolution profile, with Bendex having a slower dissolution than Ovis.Conclusion/SignificanceThe study revealed that differences in efficacy between the two brands of albendazole (ABZ) tablets against hookworm are linked to the differences in the in-vitro drug release profile. Differences in uptake and metabolism of this benzimidazole drug among different helminth species may explain that this efficacy difference was only observed in hookworms and not in the two other species. The results of the present study underscore the importance of assessing the chemical and physicochemical quality of drugs before conducting efficacy assessment in any clinical trials to ensure appropriate therapeutic efficacy and to exclude poor drug quality as a factor of reduced drug efficacy other than anthelminthic resistance. Overall, this paper demonstrates that “all medicines are not created equal”.

Investigating the Effectiveness of Current and Modified World Health Organization Guidelines for the Control of Soil-Transmitted Helminth Infections

“…Where granular data are not available, we recommend community-wide treatment. In addition, given the low drug efficacy of mebendazole (rather than albendazole) [ 20–23 ], we would expect more aggressive, higher-coverage MDA to be necessary where mebendazole is used. In clearing Trichuris , a more specific set of guidelines may be needed given the higher efficacy of an albendazole + ivermectin drug coadministration regimen.…”

“…We assume treatment with albendazole alone unless otherwise stated. An individual’s treatment results in killing each parasite with a probability of 99% ( Ascaris ), 94% (hookworm), or 60% ( Trichuris , by default, see also below) in line with measured egg reduction rates [ 20–23 ]. Each independent village’s parameters are based on field data, fitted to the age-specific prevalence of infection profiles in a specific region.…”

Toward the 2020 goal of soil-transmitted helminthiasis control and elimination

“…trichiura is unsatisfactory, and low cure rates of single-dose administration have also been reported for hookworm infection, in particular if mebendazole is used. Other factors, such as suboptimal dissolution of the tablets, may further decrease their therapeutic effects [ 36 ]. In addition, PSAC, especially those less than 3 years of age, have difficulty chewing and swallowing the relatively large tablets [ 37 ], and several deaths have been caused by aspiration and choking [ 38 ].…”

Investigation of the Quality of Antibiotics-Based Amoxicillin for Monitoring of Some Different Medicine Markets of Democratic Republic of Congo

“…However, the phenomenon affects developed countries in a certain extend and mostly developing countries where medicines manufacturing, import, supply and distribution activities are less regulated and even not at all, and where the application of Regulation is problematic and characterized by the lack or insufficiency of drug control, the random supply of drugs, corruption and interest. The consequences and dangers of poor quality medicines are multiple: therapeutic failure, drug poisoning, microbial resistance or even death [8]. Children are the most vulnerable [9].…”