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Author Spotlight: Detection and Treatment of Helicobacter pylori Infection
Published on: July 28, 2023
Efficacies of Genotypic Resistance-Guided vs Empirical Therapy for Refractory Helicobacter pylori Infection
Jyh-Ming Liou1, Po-Yueh Chen2, Jiing-Chyuan Luo3
1Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan.
Background & Aims:
We aimed to compare the efficacy of genotypic resistance-guided therapy vs empirical therapy for eradication of refractory Helicobacter pylori infection in randomized controlled trials.
Methods:
We performed 2 multicenter, open-label trials of patients with H pylori infection (20 years or older) failed by 2 or more previous treatment regimens, from October 2012 through September 2017 in Taiwan. The patients were randomly assigned to groups given genotypic resistance-guided therapy for 14 days (n = 21 in trial 1, n = 205 in trial 2) or empirical therapy according to medication history for 14 days (n = 20 in trial 1, n = 205 in trial 2). Patients received sequential therapy containing esomeprazole and amoxicillin for the first 7 days, followed by esomeprazole and metronidazole, with levofloxacin, clarithromycin, or tetracycline (doxycycline in trial 1, tetracycline in trial 2) for another 7 days (all given twice daily) based on genotype markers of resistance determined from gastric biopsy specimens (group A) or empirical therapy according to medication history. Resistance-associated mutations in 23S ribosomal RNA or gyrase A were identified by polymerase chain reaction with direct sequencing. Eradication status was determined by 13C-urea breath test. The primary outcome was eradication rate.
Results:
H pylori infection was eradicated in 17 of 21 (81%) patients receiving genotype resistance-guided therapy and 12 of 20 (60%) patients receiving empirical therapy (P = .181) in trial 1. This trial was terminated ahead of schedule due to the low rate of eradication in patients given doxycycline sequential therapy (15 of 26 [57.7%]). In trial 2, H pylori infection was eradicated in 160 of 205 (78%) patients receiving genotype resistance-guided therapy and 148 of 205 (72.2%) patients receiving empirical therapy (P = .170), according to intent to treat analysis. The frequencies of adverse effects and compliance did not differ significantly between groups.
Conclusions:
Properly designed empirical therapy, based on medication history, is an acceptable alternative to genotypic resistance-guided therapy for eradication of refractory H pylori infection after consideration of accessibility, cost, and patient preference. ClinicalTrials.gov ID: NCT01725906.
Insights
Genotypic resistance-guided therapy and empirical therapy show similar efficacy for eradicating refractory Helicobacter pylori infection. Empirical therapy is a viable alternative, considering cost and patient preference.
Area of Science:
- Gastroenterology
- Infectious Diseases
- Clinical Trials
Background:
- Refractory Helicobacter pylori infections pose a significant challenge, often requiring retreatment.
- Previous treatment regimens may fail due to antibiotic resistance.
- Genotypic resistance-guided therapy aims to optimize treatment based on specific mutations.
Purpose of the Study:
- To compare the efficacy of genotypic resistance-guided therapy versus empirical therapy for eradicating refractory H. pylori infection.
- To evaluate treatment outcomes in patients with persistent H. pylori infections.
- To determine if tailoring therapy based on genotype improves eradication rates.
Main Methods:
- Two multicenter, open-label randomized controlled trials were conducted in Taiwan.
- Patients with H. pylori infection (≥20 years) who failed ≥2 prior regimens were enrolled.
- Participants received either 14-day genotypic resistance-guided sequential therapy or empirical therapy based on medication history.
Main Results:
- In Trial 1, eradication rates were 81% for genotypic-guided therapy vs 60% for empirical therapy (P=.181).
- Trial 1 was stopped early due to low eradication with doxycycline sequential therapy (57.7%).
- In Trial 2, eradication rates were 78% for genotypic-guided therapy vs 72.2% for empirical therapy (P=.170).
Conclusions:
- Empirical therapy, guided by patient medication history, is a suitable alternative to genotypic resistance-guided therapy for refractory H. pylori.
- Treatment decisions should consider accessibility, cost, and patient preferences.
- No significant differences in adverse effects or compliance were observed between the groups.
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