Vonoprazan-Tetracycline Dual Regimen as Rescue Therapy for Helicobacter pylori Infection: Randomized Controlled Trial

Area of Science:

• Gastroenterology
• Infectious Diseases
• Pharmacology

Background:

• Helicobacter pylori eradication failure poses a significant clinical challenge.
• Developing effective rescue therapies is crucial for managing persistent infections.

Purpose of the Study:

• To evaluate the efficacy and safety of vonoprazan-tetracycline (VT) dual therapy as a rescue regimen for H. pylori infection.
• To compare VT dual therapy with standard bismuth quadruple therapy (BQT) in patients with previous eradication failures.

Main Methods:

• A prospective, open-label, randomized controlled trial involving 350 H. pylori positive adults with prior eradication failure.
• Patients were randomized to receive either 14-day VT dual therapy (vonoprazan 20 mg b.i.d. + tetracycline 500 mg t.i.d.) or 14-day BQT (lansoprazole + bismuth + tetracycline + metronidazole).
• Primary outcome was non-inferiority of eradication rates; secondary outcomes included adverse events and adherence.

Main Results:

• VT dual therapy achieved non-inferior eradication rates compared to BQT in both modified-intention-to-treat (90.6% vs 89.3%) and per-protocol (91.1% vs 92.2%) analyses.
• Treatment-emergent adverse events were significantly lower in the VT group (10.9%) than the BQT group (45.7%).
• Adherence was higher with VT dual therapy (96.0%) compared to BQT (87.4%), with no discontinuations due to adverse events in the VT group.

Conclusions:

• Fourteen-day vonoprazan-tetracycline dual therapy is an effective and well-tolerated rescue regimen for H. pylori infection.
• The simplified VT regimen demonstrates non-inferior efficacy to BQT, with substantial improvements in safety and adherence.
• VT dual therapy represents a promising alternative for managing difficult-to-eradicate H. pylori infections.