14-Day Vonoprazan-Minocycline Dual Therapy Versus Bismuth-Containing Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Single-Center Randomized Controlled Noninferiority Trial.

BACKGROUND

Rescue treatment for Helicobacter pylori infection remains challenging in regions with high antibiotic resistance. Although bismuth-containing quadruple therapy is widely recommended as an empirical rescue regimen, its medication burden may impair tolerability and adherence. This trial evaluated the efficacy and safety of 14-day vonoprazan-minocycline dual therapy compared with vonoprazan-based bismuth-containing quadruple therapy as empirical rescue treatment.

MATERIALS AND

METHODS

This single-center, prospective, open-label, randomized, controlled, noninferiority trial enrolled 186 adults aged 18-70 years with at least one previous H. pylori eradication failure. Patients were randomly assigned (1:1) to receive 14-day vonoprazan-minocycline dual therapy or vonoprazan-, amoxicillin-, minocycline-, and bismuth-containing quadruple therapy. Eradication was assessed by a 13C urea breath test 4 weeks after treatment. ITT, mITT, and PP analyses were performed, with a prespecified noninferiority margin of -10%.

RESULTS

Eradication rates in the dual therapy and quadruple therapy groups were 89.2% and 91.4% in the ITT analysis (difference, -2.2%; 95% CI, -10.5% to 6.2%; noninferiority p = 0.036), 90.2% and 92.4% in the mITT analysis (difference, -2.2%; 95% CI, -9.7% to 5.3%; noninferiority p = 0.030), and 91.2% and 93.4% in the PP analysis (difference, -2.2%; 95% CI, -9.4% to 5.0%; noninferiority p = 0.024). Noninferiority was demonstrated in the mITT and PP analyses, whereas the ITT result should be interpreted cautiously because the lower 95% CI bound crossed the margin. Adverse events were similar between treatment groups (11.8% vs. 15.1%; χ2 = 0.416; p = 0.519), and adherence was high in both groups (97.8% vs. 97.8%; p = 1.000).

CONCLUSIONS

14-day vonoprazan-minocycline dual therapy achieved eradication rates comparable to those of bismuth-containing quadruple therapy, with acceptable safety and high adherence as rescue treatment for H. pylori infection. This simplified regimen may be considered a potential empirical rescue option when susceptibility testing is not readily available, although the ITT noninferiority result warrants cautious interpretation.