Cara Helgeson, PharmD, CentraCare St. Cloud
Background: Helicobacter pylori (H. pylori) is an easily communicable infectious disease associated with poor health outcomes (e.g. peptic ulcers, gastritis, gastric cancer). While it is the most common chronic bacterial infection globally, its prevalence in North America is decreasing. The infection disproportionately impacts lower resource communities and non-White populations. H. pylori can be diagnosed by conducting a urea breath test, stool antigen test, and/or upper endoscopy. Treatment for this infection is often complicated due to regimens including three to four medications dosed multiple times per day for a duration up to two weeks, frequently accompanied by side effects that can negatively impact treatment adherence. It is recommended that all treated patients receive a test of cure four weeks after completing therapy. A treatment failure is defined as a positive test of cure demonstrating that H. pylori has persisted, which can lead to clinical and financial burdens for both the patient and healthcare system.
Evidence: The American College of Gastroenterology recently released an update from their guideline last published in 2017 for adult H. pylori treatment in North America. The clinical practice guideline (CPG) developed statements for 11 questions using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology to assess the quality of evidence (high to very low) and also give a strength of recommendation (strongly recommend versus conditionally suggest). Nearly all of the statements have a conditional recommendation and low or moderate quality evidence. Six key concepts using expert consensus were also developed when GRADE could not be applied.
Discussion: A main change observed in the 2024 CPG regarding treatment of treatment-naive patients is the removal of clarithromycin triple therapy (PPI, clarithromycin, amoxicillin OR metronidazole) and concomitant therapy (PPI, clarithromycin, amoxicillin, and a nitroimidazole) as first-line treatment (FLT) recommendations. The 2024 edition retains bismuth quadruple therapy (BQT) as a recommended FLT but now focuses on it being “optimized.” BQT consists of a proton-pump inhibitor (PPI), bismuth, nitroimidazole, and tetracycline. The emphasis on “optimization” specifically notes the following: doxycycline is not to be substituted in place of tetracycline due to a 10-17% reduction in eradication rates, the individual medications are prescribed at a sufficient frequency and dose, and the duration is for 14 days. The 2024 CPG also discusses the utilization of various novel treatment regimens as suggested alternatives to BQT FLT. These include a regimen containing the antibiotic rifabutin and treatments that involve a new-to-market, extremely potent, gastric suppressing potassium-competitive acid blocker (PCAB), vonoprazan.
A “salvage therapy” is any treatment for a patient whose H. pylori has persisted despite an initial regimen. For treatment of treatment-experienced patients, the 2024 CPG conditionally suggests using optimized BQT in patients that have yet to trial this regimen. If patients have a history of optimized BQT therapy, rifabutin triple therapy is then suggested. A major change from the 2017 guideline advocates for the avoidance of clarithromycin- and levofloxacin-based regimens unless susceptibility testing proves they’re effective; this stems from increasing resistance rates to these antibiotics.
Figure 1. 2024 ACG Clinical Practice Guideline
Clinical Impact: It’s important to have updated guidance on how to successfully eradicate H. pylori, especially in the landscape of increasing antibiotic resistance rates to certain regimens. However, many of these treatment regimens will likely need prior authorizations until insurance companies update formularies to incorporate coverage of clinical best practice guidelines. Pharmacists could play a key role in optimizing their organization's approach to H. pylori treatment via education or direct patient care. We must continue to advocate for routine post-treatment tests of cure to ensure our patients eradicate the bacteria and reduce the risk of transmission and poor clinical outcomes associated with H. pylori. The updated CPG recommends considering a patient’s previous antibiotic use and allergies to help choose a regimen that will give the best chance of eradication. Practitioners can refer to this updated, evidence-based CPG to review therapeutic regimens for both treatment-naive and treatment-experienced patients in our fight against H. pylori.
Published March 7, 2025
Reference:
- Chey WD, Howden CW, Moss SF, et al. ACG clinical guideline: treatment of Helicobacter pylori infection. Am J Gastroenterol. 2024;119(9):1730-1753. doi:10.14309/ajg.0000000000002968
- Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG clinical guideline: treatment of Helicobacter pylori infection [published correction appears in Am J Gastroenterol. 2018 Jul;113(7):1102. doi: 10.1038/s41395-018-0132-6]. Am J Gastroenterol. 2017;112(2):212-239. doi:10.1038/ajg.2016.563