Vonoprazan Dual Therapy Matched Quadruple Therapy In H Pylori Trial

Key Takeaways

• Dual, triple, and bismuth quadruple vonoprazan-based regimens were all associated with high eradication rates, and the authors reported noninferiority of dual and triple therapy versus bismuth quadruple therapy.
• Adverse events were reported in 6.4% with dual therapy, 36.0% with triple therapy, and 49.6% with bismuth quadruple therapy.
• Compliance exceeded 93% in all groups without a significant between-group difference, and the authors also described the 10-day dual regimen as using less antibiotic exposure.

In a first-line randomized comparison of Helicobacter pylori treatment, 375 adults receiving initial eradication therapy were assigned 1:1:1 to three vonoprazan-based regimens: V-DT was vonoprazan 20 mg twice daily plus amoxicillin 1 g three times daily for 10 days, V-TT was vonoprazan 20 mg twice daily plus amoxicillin 1 g twice daily plus clarithromycin 500 mg twice daily for 14 days, and V-BQT was vonoprazan 20 mg twice daily plus amoxicillin 1 g twice daily plus clarithromycin 500 mg twice daily plus bismuth 240 mg twice daily for 10 days. The primary outcome was eradication by ITT, mITT, and PP analyses, and secondary outcomes were adverse events and compliance.

ITT eradication was 92.0% (95% CI 85.8%-96.1%) with V-DT, 89.6% (82.9%-94.3%) with V-TT, and 88.8% (81.9%-93.7%) with V-BQT. mITT eradication was 94.3% (95% CI 88.5%-97.7%), 94.9% (89.3%-98.1%), and 94.1% (88.2%-97.6%), respectively. PP eradication was 94.2% (95% CI 88.4%-97.6%), 95.6% (90.0%-98.5%), and 94.8% (89.0%-98.1%), respectively. Investigators reported formal noninferiority of V-DT and V-TT versus V-BQT. Across intention-to-treat, modified intention-to-treat, and per-protocol analyses, efficacy was tightly clustered, without clear numerical separation between groups.

Safety differences were more distinct than efficacy differences, with adverse events occurring least often in the dual-therapy group and differing significantly across arms (p < 0.001). Compliance exceeded 93% in all groups, and between-group differences were not significant (p = 0.250).

The authors concluded that the 10-day dual regimen produced eradication comparable to V-BQT with fewer adverse events and less antibiotic exposure. They also said the findings support its potential as a simplified first-line option. The reported distinction between regimens centered on tolerability and treatment burden rather than eradication success during follow-up.