The efficacy and safety of a simple 14-day vonoprazan-minocycline dual therapy for Helicobacter pylori eradication: a retrospective pilot study.

Background: Current eradication regimens are not ideal for Helicobacter pylori infected patients who have difficulty choosing antibiotics due to penicillin allergy or antibiotic resistance.

Objective: To explore the efficacy and safety of a simple vonoprazan-minocycline dual therapy (VM dual therapy) in H. pylori eradication.

Design: Clinical data of patients who were prescribed 14-day VM dual therapy were retrospectively collected. The included patients were 18-70 years old and positive for ¹³C urea breath test (¹³C-UBT). They were allergic to penicillin or had a history of repeated antibiotic exposure or had failed eradication with multiple regimens containing amoxicillin. VM dual therapy consists of vonoprazan 20 mg twice daily and minocycline 100 mg twice daily. ¹³C-UBT was repeated 4-6 weeks after treatment to evaluate the therapeutic outcome.

Results: Of the 88 enrolled patients, 54 were treatment naïve, 13 had one prior eradication failure, and 21 had multiple eradication failures. The overall intention to treat (ITT) and per-protocol (PP) eradication rates were 90.9% (95% CI: 82.4-95.7) and 95.2% (95% CI: 87.6-98.5). The ITT eradication rates were 90.7% (95% CI: 78.9-96.5) in treatment-naïve patients, 84.6% (95% CI: 53.7-97.3) in patients with one prior treatment failure, and 95.2% (95% CI: 74.1-99.8) in patients with multiple failures. The PP eradication rates were 94.2% (95% CI: 83.1-98.5), 91.7% (95% CI: 59.8-99.6), and 100%, respectively. The overall incidence of adverse events was 23.0%. The common adverse reactions were nausea and mild dizziness, which could be resolved without intervention.

Conclusion: Simple VM dual therapy exhibited a good eradication rate, low incidence of adverse effects, and good adherence. It is a potential new regimen for both first-line and rescue therapy.