Journal Article

Simplified Helicobacter pylori therapy for patients with penicillin allergy: a randomised controlled trial of vonoprazan-tetracycline dual therapy

Ge, Chaoyi, Gao, Wen, Ye, Hui, Cheng, Hong, Liu, Binbin, Dong, Jinpei, Li, Jingwen, Wang, Chi, Teng, Guigen, Zhang, Xuezhi, Liu, Jianxiang, Wang, Xiaolei, Li, Jiang, Xu, Ying, Tian, Yuling, Dong, Xinhong

2024

Overview

Background and aimsThis 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.MethodsIn this randomised controlled trial, treatment-naïve adults with H. pylori infection and penicillin allergy were randomised 1:1 to receive either open-label VT dual therapy (vonoprazan 20 mg two times per day+tetracycline 500 mg three times a day) or bismuth quadruple therapy (BQT; lansoprazole 30 mg two times per day+colloidal bismuth 150 mg three times a day+tetracycline 500 mg three times a day+metronidazole 400 mg three 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.Results300 patients were randomised. The eradication rates in the VT group and the BQT group were: 92.0% (138/150, 95% CI 86.1% to 95.6%) and 89.3% (134/150, 95% CI 83.0% to 93.6%) in intention-to-treat analysis (difference 2.7%; 95% CI −4.6% to 10.0%; non-inferiority p=0.000); 94.5% (138/146, 95% CI 89.1% to 97.4%) and 93.1% (134/144, 95% CI 87.3% to 96.4%) in modified intention-to-treat analysis (difference 1.5%; 95% CI −4.9% to 8.0%; non-inferiority p=0.001); 95.1% (135/142, 95% CI 89.7% to 97.8%) and 97.7% (128/131, 95% CI 92.9% to 99.4%) in per-protocol analysis (difference 2.6%; 95% CI −2.9% to 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).ConclusionsVT dual therapy demonstrated efficacy and safety as a first-line treatment for H. pylori infection in the penicillin-allergic population, with comparable efficacy and a lower incidence of TEAEs compared with traditional BQT.Trial registration numberChiCTR2300074693.

• Publisher: BMJ Publishing Group Ltd and British Society of Gastroenterology,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Adult / Aged / Allergies / Anti-Bacterial Agents - administration & dosage / Anti-Bacterial Agents - adverse effects / Anti-Bacterial Agents - therapeutic use / Antibiotics / Bismuth - administration & dosage / Bismuth - adverse effects / Bismuth - therapeutic use / Cancer therapies / Drug dosages / Drug Hypersensitivity - etiology / Drug Therapy, Combination / Eradication / Family medical history / Female / Gastric cancer / Helicobacter Infections - drug therapy / Helicobacter Pylori / Helicobacter pylori - treatment / Hospitals / Humans / Lansoprazole - administration & dosage / Lansoprazole - adverse effects / Lansoprazole - therapeutic use / Male / Metronidazole / Metronidazole - administration & dosage / Metronidazole - adverse effects / Metronidazole - therapeutic use / Middle Aged / Patients / Penicillin / Penicillins - adverse effects / Penicillins - therapeutic use / Pharmaceuticals / Proton Pump Inhibitors - administration & dosage / Proton Pump Inhibitors - adverse effects / Proton Pump Inhibitors - therapeutic use / Pyrroles - administration & dosage / Pyrroles - adverse effects / Pyrroles - therapeutic use / Software / Statistical analysis / Sulfonamides - administration & dosage / Sulfonamides - adverse effects / Sulfonamides - therapeutic use / Tetracycline - administration & dosage / Tetracycline - adverse effects / Tetracycline - therapeutic use / Treatment Outcome