Narrative Review
Primer for Development of Guidelines for Helicobacter pylori Therapy Using Antimicrobial Stewardship

https://doi.org/10.1016/j.cgh.2021.03.026Get rights and content
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We provide a primer to assist in the difficult transition of Helicobacter pylori therapy guidelines to those that adhere to the principles of antimicrobial stewardship. This transition will entail abandonment of many of the principles that heretofore formed the basis of treatment guidelines and recommendations. The goals of antimicrobial stewardship include optimization of the use of antibiotics while reducing antimicrobial resistance. The critical outcome measure is absolute cure rate which largely restricts comparative trials to those which reliably produce high cure rates (eg, ∼95%). Therapies that fail to achieve at least a 90% cure rate should be abandoned as unacceptable. Because only optimized therapies should be prescribed, guidance on the principles and practices of optimization will we required. Therapies that contain antibiotics which do not contribute to outcome should be eliminated. Surveillance, one of the fundamental elements of antimicrobial stewardship, must be done to provide ongoing assurance that the recommended therapies remain effective. It is yet not widely recognized when utilizing otherwise highly successful therapies, the routine test of cure data is an indirect, surrogate method for susceptibility testing. To systematically guide therapy, test of cure data should be collected, shared and integrated into local antimicrobial stewardship programs to provide guidance regarding best practices to both prescribers and public health individuals. Treatment recommendations should be compatible with those of the American Society of Infectious Disease white paper on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens which include criteria for ethical active-controlled superiority studies of antibacterial agents.

Keywords

Helicobacter pylori
Antimicrobial Stewardship
Guidance
Therapy
Susceptibility Testing
Test of Cure

Abbreviations used in this paper

CMS
Centers for Medicare and Medicaid Services
FDA
Food and Drug Administration
PPI
proton pump inhibitor
WHO
World Health Organization

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Conflicts of Interest This author discloses the following: David Y. Graham is a consultant for RedHill Biopharma and Phathom Pharmaceuticals regarding novel Helicobacter pylori therapies. The remaining author discloses no conflicts.

Funding David Y. Graham is supported in part by the Office of Research and Development Medical Research Service Department of Veterans Affairs and Public Health Service Grant No. DK56338, which funds the Texas Medical Center Digestive Diseases Center.