Empirical Rescue Eradication Therapy for Helicobacter pylori Infection in Second and Subsequent Treatment Lines: Experience From 500 Cases of the Brazilian Registry on H. pylori Management (Hp-BrazilReg).

BACKGROUND

The effectiveness of anti-H. pylori treatment diminishes with therapy failure, making regional performance understanding crucial.

OBJECTIVE

To evaluate the effectiveness of empirical therapy in second-line and subsequent treatments in Brazil.

METHODS

A multicenter, prospective, noninterventional registry assessed H. pylori management outcomes by Brazilian gastroenterologists (Hp-BrazilRe, Hp-WorldReg's partner). Data were registered at e-CRF AEG-ReCap from March 2022 to October 2024 and analyzed via modified intention-to-treat (mITT) methodology. Data were subject to quality review.

RESULTS

572 patients (mean age 52 years, 64% women) were included. The primary treatment indications were dyspepsia (64%) and gastroduodenal ulcer (9.2%). Among them, 67% underwent second-line therapy, while 33% received third-line or subsequent treatments. Proton-pump inhibitors (PPIs) were administered at low (40%), standard (10%), and high doses (24%), with vonoprazan used in 26% of cases. The overall eradication rate for second-line treatment was 74%, with the most common regimen being triple therapy (PPI + amoxicillin + levofloxacin), achieving 73% eradication for 14 days and 57% for 10 days. Adding bismuth to the 14-day regimen increased effectiveness to 100% (p = 0.016). In third-line therapy, a regimen of PPI-bismuth-tetracycline-metronidazole yielded an 87% cure rate. The fourth-line dual therapy with amoxicillin-vonoprazan achieved 100% eradication, while bismuth-quadruple therapy showed similar results. Dual therapy with vonoprazan and amoxicillin was also effective in fifth-line treatments, achieving 100% effectiveness. Mild adverse events occurred in 23% of patients, with nausea being the most common (14%), and compliance was 99%.

CONCLUSION

In Brazil, the overall effectiveness of second-line therapy was suboptimal (< 90%); however, the combination of bismuth-amoxicillin-levofloxacin prescribed for 14 days reported successful cure rates. In the third-line, the classical bismuth-quadruple therapy with metronidazole-tetracycline provided acceptable results (87%). Alternatively, dual therapy with vonoprazan and amoxicillin and rifabutin-based bismuth-quadruple therapy showed promising results in third- and fifth-line rescue treatment.