Esophagus to Small Intestine
Gut. 2024;73(9):1414–20
Simplified Helicobacter pylori therapy for patients with penicillin allergy: A randomised controlled trial of vonoprazan-tetracycline dual therapy
Background and aims: This study aimed to evaluate the efficacy and safety of vonoprazan and tetracycline (VT) dual therapy as first-line treatment for Helicobacter pylori infection in patients with penicillin allergy.
Methods: In this randomised controlled trial, treatment-naive adults with H. pylori infection and penicillin allergy were randomised 1:1 to receive either open-label VT dual therapy (vonoprazan 20 mg 2 times per day + tetracycline 500 mg 3 times a day) or bismuth quadruple therapy (BQT; lansoprazole 30 mg 2 times per day + colloidal bismuth 150 mg 3 times a day + tetracycline 500 mg 3 times a day + metronidazole 400 mg 3 times a day) for 14 days. The primary outcome was non-inferiority in eradication rates in the VT dual group compared with the BQT group. Secondary outcomes included assessing adverse effects.
Results: 300 patients were randomised. The eradication rates in the VT group and the BQT group were: 92.0% (138/150, 95% confidence interval [CI]: 86.1–95.6%) and 89.3% (134/150, 95% CI: 83.0–93.6%) in intention-to-treat analysis (difference 2.7%; 95% CI: -4.6–10.0%; non-inferiority p = 0.000); 94.5% (138/146, 95% CI: 89.1–97.4%) and 93.1% (134/144, 95% CI: 87.3–96.4%) in modified intention-to-treat analysis (difference 1.5%; 95% CI: -4.9–8.0%; non-inferiority p = 0.001); 95.1% (135/142, 95% CI: 89.7–97.8%) and 97.7% (128/131, 95% CI: 92.9–99.4%) in per-protocol analysis (difference 2.6%; 95% CI: -2.9–8.3%; non-inferiority p = 0.000). The treatment-emergent adverse events (TEAEs) were significantly lower in the VT group (14.0% vs. 48.0%, p = 0.000), with fewer treatment discontinuations due to TEAEs (2.0% vs. 8.7%, p = 0.010).
Conclusions: Vonoprazan and tetracycline dual therapy demonstrated efficacy and safety as a first-line treatment for Helicobacter pylori infection in the penicillin-allergic population, with comparable efficacy and a lower incidence of treatment-emergent adverse events compared with traditional bismuth quadruple therapy.