A Modified 14-Day Dual Therapy with Vonoprazan and Amoxicillin Amplified the Advantages Over Conventional Therapies for Eradication of Helicobacter pylori: A Non-Inferiority Clinical Trial

Abstract

Purpose: The emergence of resistant strains has greatly reduced the eradication rate of H. pylori (HP) in conventional bismuth-containing quadruple therapy. Meanwhile, the new 7-day dual therapy with vonoprazan (VPZ) and amoxicillin (AMO) failed to achieve the expected therapeutic effect in China.

Patients and methods: A total of 256 untreated HP-infected patients are included in this non-inferiority clinical trial. The patients were randomly divided into three groups: 14-day dual therapy group (VPZ 20mg b.i.d + AMO 750mg t.i.d for 14 days, VA14), 14-day modified triple therapy group (VA14 + Jinghua Weikang Capsule 160mg t.i.d, VAC), and conventional bismuth-containing quadruple therapy group for 14 days (BCQ). Eradication rates, drug-related adverse events (AEs), patient compliance, and drug costs were compared among the three groups.

Results: The eradication rates in the BCQ, VA14, and VAC were 78.67, 77.33%, and 86.49% by intention-to-treat analysis, respectively, and 96.72%, 90.63%, and 92.75% by pre-protocol or modified intention-to-treat analysis, respectively. VA14 therapy indicated a non-inferiority eradication rate and advanced safety and economics to BCQ therapy. JWC further improved the eradication rate and reduced the incidence of AEs.

Conclusion: A modified 14-day dual therapy with VPZ and AMO provides satisfied efficacy as the first-line treatment for HP infection in China.

Keywords: Helicobacter pylori; Jinghua Weikang capsule; amoxicillin; vonoprazan.

Figure 1

Schematic diagram of patient selection and study design. Of the 256 H. pylori-infected patients assessed for eligibility, 32 were excluded from this study, 14 were ineligible, and 18 refused. A total of 224 study subjects were successfully randomized and allocated to the BCQ group (n=75 of ITT population, n=61 of mITT and PP population), VA14 group (n=75 of ITT population, n=64 of mITT and PP population) and the VAC group (n =74 of ITT population, n=69 of mITT and PP population).