Frontiers in Immunology (Jan 2023)

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

DOI
https://doi.org/10.3389/fimmu.2022.1049908
Journal volume & issue
Vol. 13

Abstract

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Background and aimWe 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.MethodsThis 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.ResultsA 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.ConclusionVPZ 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.

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