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Assessment of efficacy and quality of two albendazole brands commonly used against soil-transmitted helminth infections in school children in Jimma Town, Ethiopia

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Abstract
Background : There 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 Findings : A 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 (similar to 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/Significance : The 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".
Keywords
MEBENDAZOLE, INTENSITY, IN-VITRO, TRICHURIS-TRICHIURA, DRUG EFFICACY, VIVO

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MLA
Yohannes, Sileshi Belew et al. “Assessment of Efficacy and Quality of Two Albendazole Brands Commonly Used Against Soil-transmitted Helminth Infections in School Children in Jimma Town, Ethiopia.” PLOS NEGLECTED TROPICAL DISEASES 9.9 (2015): n. pag. Print.
APA
Yohannes, S. B., Getachew, M., Wega, S. S., Mohammed, T., Deti, H., D’Hondt, M., Wynendaele, E., et al. (2015). Assessment of efficacy and quality of two albendazole brands commonly used against soil-transmitted helminth infections in school children in Jimma Town, Ethiopia. PLOS NEGLECTED TROPICAL DISEASES, 9(9).
Chicago author-date
Yohannes, Sileshi Belew, Mestawet Getachew, Sultan Suleman Wega, Tesfaye Mohammed, Habetewold Deti, Matthias D’Hondt, Evelien Wynendaele, et al. 2015. “Assessment of Efficacy and Quality of Two Albendazole Brands Commonly Used Against Soil-transmitted Helminth Infections in School Children in Jimma Town, Ethiopia.” Plos Neglected Tropical Diseases 9 (9).
Chicago author-date (all authors)
Yohannes, Sileshi Belew, Mestawet Getachew, Sultan Suleman Wega, Tesfaye Mohammed, Habetewold Deti, Matthias D’Hondt, Evelien Wynendaele, Zeleke Mekonnen Kurmane, Jozef Vercruysse, Luc Duchateau, Bart De Spiegeleer, and Bruno Levecke. 2015. “Assessment of Efficacy and Quality of Two Albendazole Brands Commonly Used Against Soil-transmitted Helminth Infections in School Children in Jimma Town, Ethiopia.” Plos Neglected Tropical Diseases 9 (9).
Vancouver
1.
Yohannes SB, Getachew M, Wega SS, Mohammed T, Deti H, D’Hondt M, et al. Assessment of efficacy and quality of two albendazole brands commonly used against soil-transmitted helminth infections in school children in Jimma Town, Ethiopia. PLOS NEGLECTED TROPICAL DISEASES. 2015;9(9).
IEEE
[1]
S. B. Yohannes et al., “Assessment of efficacy and quality of two albendazole brands commonly used against soil-transmitted helminth infections in school children in Jimma Town, Ethiopia,” PLOS NEGLECTED TROPICAL DISEASES, vol. 9, no. 9, 2015.
@article{7093706,
  abstract     = {Background : There 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 Findings : A 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 (similar to 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/Significance : The 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".},
  articleno    = {e0004057},
  author       = {Yohannes, Sileshi Belew and Getachew, Mestawet and Wega, Sultan Suleman and Mohammed, Tesfaye and Deti, Habetewold and D'Hondt, Matthias and Wynendaele, Evelien and Mekonnen Kurmane, Zeleke and Vercruysse, Jozef and Duchateau, Luc and De Spiegeleer, Bart and Levecke, Bruno},
  issn         = {1935-2735},
  journal      = {PLOS NEGLECTED TROPICAL DISEASES},
  keywords     = {MEBENDAZOLE,INTENSITY,IN-VITRO,TRICHURIS-TRICHIURA,DRUG EFFICACY,VIVO},
  language     = {eng},
  number       = {9},
  pages        = {15},
  title        = {Assessment of efficacy and quality of two albendazole brands commonly used against soil-transmitted helminth infections in school children in Jimma Town, Ethiopia},
  url          = {http://dx.doi.org/10.1371/journal.pntd.0004057},
  volume       = {9},
  year         = {2015},
}

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