The implementation of PCR-guided therapy in the eradication of Helicobacter pylori: experience from the European Registry on H. pylori management (Hp-EuReg)

Abstract

Background: Optimal clinical management of Helicobacter pylori (H. pylori) infection remains challenging considering its growing antimicrobial resistance. Tailored therapy might enhance treatment success.

Objective: The aim of this study was to analyse the effectiveness of PCR-guided therapy in H. pylori eradication, both as first-line and rescue therapy.

Methods: Data were obtained from the prospective, European multicentre Registry on H. pylori Management (Hp-EuReg). Adult PCR-tested (stool and gastric samples) H. pylori-infected patients registered at AEG-REDCap e-CRF were analysed. Effectiveness was evaluated by per protocol (PP) analysis.

Results: In total, 265 patients were included (130 treatment-naïve and 135 previously treated), 77% underwent gastric PCR-testing. In the first-line, 52% received 14-day prescriptions, and 31% high-dose proton pump inhibitors (PPIs). In the rescue-line, 55% were prescribed 14-day treatment, and 61% high-dose PPIs. Clarithromycin and fluoroquinolone resistance rates in the first-line were 31% and 33%, and 62% and 53% in the rescue-line, respectively. The overall effectiveness of PCR-guided therapy was 90% (95% first-line and 86% rescue-line). Most frequent first-line regimens were: quadruple concomitant therapy with clarithromycin+amoxicillin+metronidazole (48%), bismuth quadruple therapy as single-capsule containing bismuth+tetracycline+metronidazole (30%) and triple therapy with PPI+clarithromycin+amoxicillin (5.4%), providing an effectiveness of 95%, 97% and 100%, respectively. In the rescue-line, most frequent regimens were: single-capsule bismuth quadruple (43%), PPI-clarithromycin+amoxicillin+metronidazole (27%) and PPI-amoxicillin+moxifloxacin (11%), achieving 87%, 94% and 93% effectiveness, respectively. Adverse event incidence was 15%.

Conclusion: PCR-guided therapy showed optimal results in all therapy lines. In regions with high (>15%) clarithromycin resistance, clarithromycin-based first-line therapy could still represent a good option provided pretreatment antibiotic sensitivity is assessed.