Esophagus to Small Intestine
Am J Gastroenterol. 2023;118(4):627−34
Ten-day vonoprazan-amoxicillin dual therapy as a first-line treatment of Helicobacter pylori infection compared with bismuth-containing quadruple therapy
Introduction: No study has investigated the efficacy and safety of vonoprazan-amoxicillin dual therapy compared with bismuth quadruple thera-py (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 1000 mg twice/day), and B-quadruple (esomeprazole 20 mg + bismuth 200 mg + amoxicillin 1000 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 non-inferiority margin of -10%. The AE 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 adverse event rates, and similar adherence compared with B-quadruple therapy as a first-line therapy for Helicobacter pylori infection. However, the efficacy of VA-dual therapy was not acceptable.