A RECENT randomised controlled trial assessed the efficacy and safety of vonoprazan and tetracycline (VT) dual therapy as a first-line treatment for Helicobacter pylori infection in patients with a penicillin allergy. The study involved treatment-naïve adults who were randomly assigned in a 1:1 ratio to receive either VT dual therapy (vonoprazan 20 mg twice daily and tetracycline 500 mg three times daily) or bismuth quadruple therapy (BQT), which included lansoprazole, colloidal bismuth, tetracycline, and metronidazole, all administered over a 14-day period. The primary aim was to establish whether VT dual therapy was non-inferior to BQT in terms of eradication rates, while secondary outcomes focused on adverse effects.
A total of 300 patients were enrolled, with results demonstrating high eradication rates in both groups. In the intention-to-treat analysis, eradication rates were 92.0% for the VT group and 89.3% for the BQT group, confirming non-inferiority. Similar outcomes were observed in the modified intention-to-treat analysis (94.5% vs 93.1%) and the per-protocol analysis (95.1% vs 97.7%), with all results supporting the non-inferiority of VT therapy. Notably, patients receiving VT dual therapy experienced significantly fewer treatment-emergent adverse events (TEAEs), reported at 14.0% compared to 48.0% in the BQT group. Additionally, treatment discontinuation due to adverse events was markedly lower in the VT group (2.0% vs 8.7%).
These findings suggest that VT dual therapy is both effective and well-tolerated, offering a valuable alternative to traditional BQT for patients with penicillin allergies. The lower incidence of adverse events, coupled with comparable eradication rates, positions VT dual therapy as a promising first-line treatment option for H. pylori infection in this specific patient population.
Katie Wright, EMJ
Reference
Gao W et al. Simplified Helicobacter pylori therapy for patients with penicillin allergy: a randomised controlled trial of vonoprazan-tetracycline dual therapy. Gut. 2024;73(9):1414-20.
