Fourteen-day vonoprazan and low- or high-dose amoxicillin dual therapy for eradicating Helicobacter pylori infection: A prospective, open-labeled, randomized non-inferiority clinical study

Yi Hu; Xin Xu; Xiao-Shun Liu; Cong He; Yao-Bin Ouyang; Nian-Shuang Li; Chuan Xie; Chao Peng; Zhen-Hua Zhu; Yong Xie; Xu Shu; Yin Zhu; David Y Graham; Nong-Hua Lu

doi:10.3389/fimmu.2022.1049908

Fourteen-day vonoprazan and low- or high-dose amoxicillin dual therapy for eradicating Helicobacter pylori infection: A prospective, open-labeled, randomized non-inferiority clinical study

Front Immunol. 2023 Jan 13:13:1049908. doi: 10.3389/fimmu.2022.1049908. eCollection 2022.

Authors

Yi Hu^{1

2}, Xin Xu^{1

2}, Xiao-Shun Liu^{1

2}, Cong He^{1

2}, Yao-Bin Ouyang^{1

2}, Nian-Shuang Li^{1

2}, Chuan Xie^{1

2}, Chao Peng^{1

2}, Zhen-Hua Zhu^{1

2}, Yong Xie^{1

2}, Xu Shu^{1

2}, Yin Zhu^{1

2}, David Y Graham³, Nong-Hua Lu^{1

2}

Affiliations

¹ Department Of Gastroenterology, Digestive Disease Hospital, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China.
² JiangXi Clinical Research Center for Gastroenterology, Nanchang, Jiangxi, China.
³ Department of Medicine, Michael E. DeBakey VA Medical Center, and Baylor College of Medicine, Houston, TX, United States.

Abstract

Background and aim: We previously reported that vonoprazan-amoxicillin (VA) dual therapy for 7 or 10 days is not satisfactorily efficacious for Helicobacter pylori (H. pylori) eradication. We aimed to explore the efficacy of VA dual therapy for 14 days as a first-line treatment for H. pylori infection.

Methods: This was a single center, prospective, open-labeled, randomized non-inferiority clinical study conducted in China. Treatment naïve H. pylori infected patients were randomized into two groups: 20 mg vonoprazan (VPZ) b.i.d. in combination with low-dose (1000 mg b.i.d.) or high-dose (1000 mg t.i.d) amoxicillin for 14 days. ¹³C-urea breath tests were used to access the cure rate at least 4 weeks after treatment.

Results: A total of 154 patients were assessed and 110 subjects were randomized. The eradication rate of VPZ with b.i.d. amoxicillin or t.i.d. amoxicillin for 14 days was 89.1% and 87.3% by intention-to-treat analysis, respectively, and 94.1% and 95.9% by per-protocol analysis, respectively. The eradication rate and incidence of adverse events were not different between the two groups.

Conclusion: VPZ with b.i.d. or t.i.d. amoxicillin for 14 days provides satisfactory efficacy as a first-line treatment for H. pylori infection in China.

Keywords: Helicobacter pylori; amoxicillin; dual therapy; efficacy; vonoprazan.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Amoxicillin / adverse effects
Anti-Bacterial Agents / adverse effects
Clarithromycin / therapeutic use
Helicobacter Infections* / drug therapy
Helicobacter pylori*
Humans
Prospective Studies
Proton Pump Inhibitors / therapeutic use

Substances

Amoxicillin
Anti-Bacterial Agents
Clarithromycin
Proton Pump Inhibitors

Grants and funding

This study was supported by the National Natural Science Foundation of China (82000531 and 82170580); the Project for Academic and Technical Leaders of Major Disciplines in Jiangxi Province (20212BCJL23065); the Key Research and Development Program of Jiangxi Province (20212BBG73018); the Youth Project of the Jiangxi Natural Science Foundation (20202BABL216006); the Key Fund of the Jiangxi Education Department (GJJ190007); the National Science and Technology Award Reserve Cultivation Project (20192AEI91008); and The First Affiliated Hospital of Nanchang University Clinical Research and Cultivation Project (YFYLCYJPY202002).