Optimization of vonoprazan-amoxicillin dual therapy for eradicating Helicobacter pyloriinfection in China: A prospective, randomized clinical pilot study

Helicobacter. 2022 Aug;27(4):e12896. doi: 10.1111/hel.12896. Epub 2022 Apr 25.


Background: Vonoprazan-amoxicillin (VA) dual therapy has been shown to achieve acceptable cure rates for treatment of Helicobacter pylori(H. pylori) in Japan. Its effectiveness in other regions is unknown. We aimed to explore the efficacy of VA dual therapy as first-line treatment for H. pyloriinfection in China.

Methods: This was a single center, prospective, randomized clinical pilot study conducted in China. Treatment naive H. pyloriinfected patients were randomized to receive either low- or high-dose amoxicillin-vonoprazan consisting of amoxicillin 1 g either b.i.d. or t.i.d plus VPZ 20 mg b.i.d for 7 or 10 days. 13 C-urea breath tests were used to access the cure rate at least 4 weeks after treatment.

Results: Three hundred and twenty-three patients were assessed, and 119 subjects were randomized. The eradication rates of b.i.d. amoxicillin for 7 and 10 days, t.i.d. amoxicillin for 7 and 10 days were 66.7% (16/24), 89.2% (33/37), 81.0% (17/21), and 81.1% (30/37) (p = .191) by intention-to-treat analysis, respectively, and 72.7% (16/22), 89.2% (33/37), 81.0% (17/21), and 81.1% (30/37) (p = .454) by per-protocol analysis, respectively.

Conclusion: Neither 7- or 10-day VA dual therapy with b.i.d. or t.i.d. amoxicillin provides satisfied efficacy as the first-line treatment for H. pyloriinfection in China. Further optimization is needed.

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

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Amoxicillin / therapeutic use
  • Anti-Bacterial Agents / therapeutic use
  • Clarithromycin / therapeutic use
  • Drug Therapy, Combination
  • Helicobacter Infections* / drug therapy
  • Helicobacter pylori*
  • Helicobacter*
  • Humans
  • Pilot Projects
  • Prospective Studies
  • Proton Pump Inhibitors / therapeutic use
  • Pyrroles
  • Sulfonamides
  • Treatment Outcome


  • 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
  • Anti-Bacterial Agents
  • Proton Pump Inhibitors
  • Pyrroles
  • Sulfonamides
  • Amoxicillin
  • Clarithromycin