Few later-line Heliobacter pylori (H pylori)empirical treatments achieved high eradication rates (90%), according to study findings published in Gut.
This analysis was part of Hp-EuReg, which was a multicenter, prospective, noninterventional registry launched in 2013 and promoted by up to 200 investigators from 28 countries. The goal of this study was to assess use of empirical third- and later-line H pylori treatments through September 2021 across Europe and evaluate their efficacy.
The study included 1519 third-, 439 fourth-, 145 fifth-, and 41 sixth-line empirical treatments for H pylori. The treatment recipients had a mean age of 51.5 (SD, 13.6) years, 68.9% were women, 89.7% were White, 93.8% had no drug allergies, 60.5% had dyspepsia, and 13.6% had an ulcer.
Stratified by year, 2016 had the highest number of patients requiring later-line H pylori treatment (n=366), followed by 2015 (n=292) and 2017 (n=254).
The empirical treatments were quadruple (58.7%), triple (37.1%), sequential (2.3%), or dual (1.9%) therapies. Most regimens were 10- (51.9%) or 14- (40.0%) day treatments. Most patients (83.8%) had good compliance (³90% drug intake).
A total of 44 treatment strategies were reported in the Hp-EuReg registry. Ranked by treatment, the most common was:
- Proton pump inhibitor (PPI) plus 3-in-1 capsule containing bismuth, tetracycline, and metronidazole (24.7%);
- PPI plus amoxicillin and levofloxacin (15.0%);
- PPI plus amoxicillin and rifabutin (13.0%);
- PPI plus metronidazole, tetracycline hydrochloride, and bismuth (8.3%);
- PPI plus amoxicillin, levofloxacin, and bismuth (6.5%); and
- PPI plus metronidazole, doxycycline, and bismuth (5.4%).
In general, PPI was administered at high (48.6%), low (34.5%), and standard (15.7%) doses.
In the modified intention-to-treat analysis, the effectiveness of all therapies was 73.7% across Europe. Stratified by region, the highest effectiveness was observed in the east (85.5%) and the lowest effectiveness in the north (58.9%). Overall, effectiveness rates decreased with later-line therapies, from 78.4% for third-line therapies to 47.5% for sixth-line therapies.
Among the 16 most common regimens, the highest effectiveness rates were observed for PPI plus amoxicillin, metronidazole, and bismuth (88.9%); PPI plus single-capsule bismuth, tetracycline, and metronidazole (84.8%); and PPI plus amoxicillin and levofloxacin (77.8%). Notably, the eradication rates for bismuth, tetracycline, and metronidazole regimens were superior when delivered in the single-capsule formulation (86%) vs traditional delivery (74%).
In the multivariate analysis, H pylori eradication with third-line therapy was associated with 12 day compared with seven day regimens (odds ratio [OR], 8.57; P =.004); PPI plus single-capsule bismuth, tetracycline, and metronidazole or metronidazole, tetracycline, and bismuth (OR, 5.15; 95% CI, 1.69-15.69, P =.004); compliance of at least 90% (OR, 3.29; 95% CI, 1.70-6.35, P =0.000); and high PPI dose compared with low dose (OR, 2.13; 95% CI, 1.55-2.94, P =0.000).
This study was limited by the lack of a drug resistance analysis.
The study authors conclude, “[A] wide variety of empirical treatments are used in Europe beyond the second line, although single-capsule bismuth quadruple has become the most prescribed rescue therapy. Only 10-day single-capsule bismuth quadruple therapy, 14-day traditional bismuth quadruple therapy and 14-day levofloxacin triple therapy achieve the 90% effectiveness threshold in some settings.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Burgos-Santamaría D, Nyssen OP, Gasbarrini A, et al. Empirical rescue treatment of Helicobacter pylori infection in third and subsequent lines: 8-year experience in 2144 patients from the European Registry on H. pylori management (Hp-EuReg). Gut. Published online December, 5 2022. doi:10.1136/gutjnl-2022-328232