Esophagus to Small Intestine
Vonoprazan triple and dual therapy for Helicobacter pylori infection in the United States and Europe: Randomized clinical trial
Background and aims: Novel, effective treatments for Helicobacter pylori infection are needed. This study evaluated the efficacy of vonoprazan, a potassium-competitive acid blocker, versus standard treatment on H. pylori eradication in the United States and Europe.
Methods: In a randomized, controlled, phase 3 trial, treatment-naive adults with H. pylori infection were randomized 1:1:1 to open-label vonoprazan dual therapy (20 mg vonoprazan twice daily; 1 g amoxicillin 3 times daily), or double-blind triple therapy twice a day (vonoprazan 20 mg or lansoprazole 30 mg; amoxicillin 1 g; clarithromycin 500 mg) for 14 days. The primary outcome was non-inferiority in eradication rates in patients without clarithromycin- and amoxicillin-resistant strains (non-inferiority margin 10%). Secondary outcomes assessed superiority in eradication rates in clarithromycin-resistant infections, and in all patients.
Results: A total of 1046 patients were randomized. Primary outcome eradication rates (non-resistant strains): vonoprazan triple therapy 84.7%, dual therapy 78.5%, versus lansoprazole triple therapy 78.8% (both non-inferior; difference 5.9%; 95% confidence interval [CI]: -0.8–12.6; p < 0.001; difference -0.3%; 95% CI: -7.4–6.8; p = 0.007, respectively). Eradication rates in clarithromycin-resistant infections: vonoprazan triple therapy 65.8%, dual therapy 69.6%, versus lansoprazole triple therapy 31.9% (both superior; difference 33.9%; 95% CI: 17.7–48.1; p < 0.001; difference 37.7%; 95% CI: 20.5–52.6; p < 0.001, respectively). In all patients, vonoprazan triple and dual therapy were superior to lansoprazole triple therapy (80.8% and 77.2%, respectively, vs. 68.5%; difference 12.3%; 95% CI: 5.7–18.8; p < 0.001; difference 8.7%; 95% CI: 1.9–15.4; p = 0.013). Overall frequency of treatment-emergent adverse events was similar between vonoprazan and lansoprazole regimens (p > 0.05).
Conclusion: Both vonoprazan-based regimens were superior to proton-pump inhibitor-based triple therapy in clarithromycin-resistant strains and in the overall study population.