Introduction

It is not yet clear what is the best first-line empirical therapy in patients with Helicobacter pylori (H. pylori) infection. For this reason, it is important to constantly monitor the effectiveness of the different therapies used in clinical practice.

Aims & Methods

The aim of this study was therefore to assess the effectiveness of empirical first-line treatment prescribed in Italy evaluating the European Registry on H. pylori Management (Hp-EuReg). The Hp-EuReg is an international multicentre prospective non-interventional registry recording information on H. pylori infection management since 2013. All infected adult patients enrolled were systematically registered at AEG-REDCap e-CRF. Data of all H. pylori-positive treatment-naïve patients enrolled from 2013 to December 2023 by Italian centres participating in the Hp-EuReg, were extracted, subject to quality control, and analysed. The effectiveness of the first-line treatment empirically prescribed was evaluated according to the modified intention-to-treat (including all patients that completed follow-up, i.e., a confirmatory test of success or failure available after eradication treatment), and per-protocol analysis (including all patients that completed follow-up and took at least 90% of the treatment drugs).

Results

In total, 4,144 patients were included for analysis; the mean age was 52 years (SD ± 5), and 60% of patients were women. Overall, 1.0% of the cases were allergic to penicillin. Among those non-allergic to penicillin, 10-day sequential therapy (mainly as PPI-clarithromycin-amoxicillin-tinidazole) was most commonly prescribed (54%), followed by 10-day single capsule bismuth quadruple therapy with metronidazole and tetracycline (19 %), and 10 or 14-day non-bismuth concomitant treatment (mainly as clarithromycin-amoxicillin-tinidazole) (9.3%), providing these regimens optimal cure rates (91.5%, 95.5%, 92% and 97%; respectively). Additional first-line prescriptions encompassed 7, 10 or 14-day triple therapy with PPI-clarithromycin-amoxicillin (5.5%), and 10-day triple therapy with PPI- -levofloxacin-amoxicillin (2.9%) (see Table 1).

Table 1; Effectiveness by modified intention-to-treat (mITT), and per-protocol (PP) analyses of first-line empirical treatment in patients not allergic to penicillin enrolled in the Italian centres participating in the European Registry on H. pylori management (Hp-EuReg).

Conclusion

Among the first-line empiric treatments prescribed by the Italian centres participating in the Hp-EuReg, only single-capsule bismuth quadruple therapy with metronidazole-tetracycline-bismuth, sequential therapy with clarithromycin-amoxicillin-tinidazole, and non-bismuth concomitant therapy with clarithromycin-amoxicillin-tinidazole, achieved over 90% effectiveness.

Disclosure

Olga P. Nyssen received research funding from Mayoly and Allergan; Antonio Gasbarrini served as consultant for Abbvie, Actial, Alpha-Sigma, Eisai, Gilead, Malesci; Maria Pina Dore received funding from Sanofi, Takeda; Alfredo Di Leo served as a consultant for THD SpA; Gerardo Nardone received research grant from Sofar S.p.a and Alfasigma; Francis Mégraud received research grant from Allergan, bioMerieux, Mobidiag (to the institution), and as speaker from Biocodex and Mayoly; Claudio Borghi served as speaker, consultant, and advisory member for Servier, Novo‐Nordisk, Astra‐Zeneca,Sanofi; Javier P. Gisbert served as speaker, consultant, and advisory member for or received research funding from Mayoly, Allergan, Diasorin, GebroPharma, and Riche.