Abstract
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 (13)C urea breath test ((13)C-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. (13)C-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.