Journal Article

Efficacy and cost-effectiveness analysis of 10-day versus 14-day eradication of Helicobacter pylori infection with vonoprazan amoxicillin: a prospective, multicenter, randomized controlled trial

Jie, Qiong, Zhang, Zhenyu, Wang, Jianrong, Peng, Peng, Duan, Zhaotao, Ding, Yanbing, Chen, Guangxia, Hu, Kewei, Li, Hui, Liu, Min, Ding, Lixia, Wang, Ruifang, Dai, Xiaorong, Li, Xiangsu, Wu, Xudong, Xu, Xiaodan, Zhan, Qiang, Dong, Yunfan, Hu, Duanmin, Pan, Chengyu, Yang, Faming

2025

Overview

To evaluate the efficacy and cost-effectiveness of 10-day vonoprazan-amoxicillin (VA) dual therapy compared to 14-day VA therapy. A non-inferiority trial was carried out at 10 clinical centers to recruit patients with H. pylori infection. Subjects were assigned at random to either the group for 10-day or 14-day, and where given vonoprazan 20 mg bid and amoxicillin 1 g tid. Comparisons were made in terms of eradication rates, adverse events, cost-effectiveness, and compliance. 914 participants were enrolled and randomly assigned to either the 10-day or 14-day VA groups. Using the intention-to-treat principle and multiple imputation for missing outcomes, the analysis showed an eradication rate of 88.79% in the 10-day group and 92.37% in the 14-day group (P = 0.064). The eradication rates were 89.14% and 93.35% by per-protocol analysis (P = 0.037). There were no significant differences in adverse events or compliance between the groups (P > 0.05). Logistic regression analysis indicated that smoking and prior failure of eradication were risk factors influencing the eradication rate (P < 0.05). For the economic evaluation, the cost-effectiveness ratio (CER) of the 10-day group was 426.30 yuan, the CER of the 14-day group was 485.27 yuan, and the incremental cost-effectiveness ratio was 1680.23 yuan. In probability sensitivity analysis, the cost-effectiveness acceptability curve showed that when the willingness-to-pay(WTP) threshold was below 1742 yuan, the 10-day group was more cost-effective. When the WTP threshold was above 1742 yuan, the 14-day group was more cost-effective. In this study, the 10-day VA was not found to be inferior to the 14-day VA. Compared with the 14-day group, the 10-day group is more cost-effective, but as the WTP threshold increases to 1742 yuan, the probability of the 14-day group being more cost-effective was greater than that of the 10-day group. Smoking and previous eradication attempts were associated with the eradication failure of VA therapy. https://clinicaltrials.gov/, identifier NCT05469685.

• Publisher: Frontiers Media SA,Frontiers Media S.A
• Subject: Adverse events / Amoxicillin / Antibiotics / Breath tests / Clinical trials / Compliance / Consent / Cost analysis / cost-effectiveness / Drug dosages / dual therapy / Eradication / Helicobacter pylori / Infections / Pharmaceutical industry / Pharmacoeconomics / Pharmacology / Questionnaires / Risk factors / Sample size / Sensitivity analysis / Smoking / Success / vonoprazan