VA dual therapy for H. pylori
Trial question
Is short course vonoprazan/amoxicillin dual therapy noninferior to standard bismuth-based quadruple therapy in patients with H. pylori infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
57.0% female
43.0% male
N = 314
314 patients (180 female, 134 male)
Inclusion criteria: treatment-naïve patients with H. pylori infection
Key exclusion criteria: administration of antibiotics, bismuth, or acid inhibitor 4 weeks before inclusion; pregnancy or lactation; allergy to study drugs; history of gastrectomy; gastric malignancy; gastroduodenal ulcer with recent hemorrhage or signs of hemorrhage within 4 weeks
Interventions
N=157 VA-dual therapy (vonoprazan/amoxicillin dual therapy for 10 days)
N=157 B-quadruple therapy (bismuth-based quadruple therapy for 14 days)
Primary outcome
Helicobacter pylori eradication rate in intention to treat analysis
86
89.2
89.2 %
66.9 %
44.6 %
22.3 %
0.0 %
VA-dual
therapy
B-quadruple
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in H. pylori eradication rate in the intention to treat analysis (86% vs. 89.2%; ARD -3.2, 95% CI -10.5 to 4.1)
Secondary outcomes
No significant difference in H. pylori eradication rate in the modified intention to treat analysis (88.2% vs. 91.5%; ARD -3.3, 95% CI -10.1 to 3.5)
No significant difference in H. pylori eradication rate in the per protocol analysis (90.8% vs. 91.3%; ARD -0.5, 95% CI -7.2 to 6.2)
Safety outcomes
No significant difference in moderate adverse events.
Significant difference in adverse events (21.0% vs. 43.9%).
Conclusion
In treatment-naïve patients with H. pylori infection, VA-dual therapy was noninferior to B-quadruple therapy with respect to H. pylori eradication rate in the intention to treat analysis.
Reference
Tian-Lian Yan, Jing-Hua Wang, Xin-Jue He et al. Ten-Day Vonoprazan-Amoxicillin Dual Therapy vs Standard 14-Day Bismuth-Based Quadruple Therapy for First-Line Helicobacter pylori Eradication: A Multicenter Randomized Clinical Trial. Am J Gastroenterol. 2024 Apr 1;119(4):655-661.
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