Ten-Day Vonoprazan-Amoxicillin Dual Therapy as a First-Line Treatment of Helicobacter pylori Infection Compared With Bismuth-Containing Quadruple Therapy

Abstract

INTRODUCTION:No study has investigated the efficacy and safety of vonoprazan-amoxicillin dual therapy compared with bismuth quadruple therapy (B-quadruple). This study aimed to evaluate the efficacy and safety of 10-day vonoprazan-amoxicillin dual therapy as a first-line treatment of Helicobacter pylori infection compared with B-quadruple and to explore the optimal dosage of amoxicillin in the dual therapy.METHODS:A total of 375 treatment-naive, H. pylori-infected subjects were randomly assigned in a 1:1:1 ratio into 3 regimen groups including VHA-dual (vonoprazan 20 mg twice/day + amoxicillin 750 mg 4 times/day), VA-dual (vonoprazan 20 mg + amoxicillin 1,000 mg twice/day), and B-quadruple (esomeprazole 20 mg + bismuth 200 mg + amoxicillin 1,000 mg + clarithromycin 500 mg twice/day). Eradication rates, adverse events (AEs), and compliance were compared between 3 groups.RESULTS:The eradication rates of B-quadruple, VHA-dual, and VA-dual were 90.9%, 93.4%, and 85.1%, respectively, by per-protocol analysis; 89.4%, 92.7%, and 84.4%, respectively, by modified intention-to-treat analysis; 88.0%, 91.2%, and 82.4%, respectively, by intention-to-treat analysis. The efficacy of the VHA-dual group was not inferior to the B-quadruple group (P < 0.001), but VA-dual did not reach a noninferiority margin of −10%. The AEs rates of the B-quadruple group were significantly higher than those of the VHA-dual (P = 0.012) and VA-dual (P = 0.001) groups. There was no significant difference in medication compliance among 3 treatment groups (P = 0.995).CONCLUSIONS:The 10-day VHA-dual therapy provided satisfactory eradication rates of >90%, lower AEs rates, and similar adherence compared with B-quadruple therapy as a first-line therapy for H. pylori infection. However, the efficacy of VA-dual therapy was not acceptable.

The Efficacy and Safety of Regimens for Helicobacter pylori Eradication Treatment in China

“…145 Moreover, one trial involving 1046 patients from the United States and Europe demonstrated that both vonoprazan-based triple and dual regimens were superior to PPI-based TT in clarithromycin-resistant strains and in the overall study population, and the eradication rates of vonoprazan combined with amoxicillin in 2 domestic studies with 10 days or 14 days were 87.3% to 93.4%. 146,147 Therefore, both VBQT and the vonoprazan-amoxicillin regimen, not included in this study, might achieve good performance in H. pylori eradication and potentially be first-line therapies in China, but more clinical studies and real-world studies are needed to confirm this.…”

Efficacy and safety of vonoprazan‐based dual therapy and esomeprazole‐based dual therapy in eradicating primary Helicobacter pylori infection: A propensity score matching analysis

“…In a prospective study of 375 treatment-naive H. pyloriinfected patients, the incidence rate of AEs in the VA-dual group (VPZ 20 mg bid + AMO 1000 mg tid) was only 8.2% with no severe AEs. 27 Besides, only mild AEs were found in dual therapy with VPZ and AMO in Japanese patients. 18 Additionally, studies have evaluated the impact of VPZ-based H. pylori therapy on gut microbiota 1-year post-therapy.…”

“…In previous studies of dual therapy with VPZ and AMO (VA) conducted in Japan, the eradication rates were 84.5% 26 and 92.9% 18 according to ITT analysis, suggesting its efficacy as an eradication regimen. In China, Qian et al 27 reported that 10‐day VA dual therapy with different doses of AMO achieved satisfactory efficacy as the first‐line treatment. Consistent with our results, 14‐day VA dual therapy (20 mg VPZ bid + 1000 mg AMO tid) resulted in over 87% eradication rates in treatment‐naive H. pylori infected patients in Nanchang according to ITT analysis 28 .…”

“…However, all these subjects showed resolution of symptoms after drug withdrawal or symptomatic treatment for several days. In a prospective study of 375 treatment‐naive H. pylori ‐infected patients, the incidence rate of AEs in the VA‐dual group (VPZ 20 mg bid + AMO 1000 mg tid) was only 8.2% with no severe AEs 27 . Besides, only mild AEs were found in dual therapy with VPZ and AMO in Japanese patients 18 .…”

Research trends on vonoprazan‐based therapy for Helicobacter pylori eradication: A bibliometric analysis from 2015 to 2023

“…VA dual therapy for 7 days achieved low eradication rates (< 80%). 10,26 Qian et al 27 studied 250 H. pylori-infected subjects who received VPZ in combination with a low (1 g b.i.d.) or high (0.75 g q.i.d.)…”