Published online May 28, 2023. doi: 10.3748/wjg.v29.i20.3133
Peer-review started: February 27, 2023
First decision: March 13, 2023
Revised: March 25, 2023
Accepted: April 23, 2023
Article in press: April 23, 2023
Published online: May 28, 2023
Vonoprazan (VPZ)-based regimens are an effective first-line therapy for Helicobacter pylori (H. pylori) infection. However, their value as a rescue therapy needs to be explored.
To assess a VPZ-based regimen as H. pylori rescue therapy.
This prospective, single-center, clinical trial was conducted between January and August 2022. Patients with a history of H. pylori treatment failure were administered 20 mg VPZ twice daily, 750 mg amoxicillin 3 times daily, and 250 mg Saccharomyces boulardii (S. boulardii) twice daily for 14 d (14-d VAS regimen). VPZ and S. boulardii were taken before meals, while amoxicillin was taken after meals. Within 3 d after the end of eradication therapy, all patients were asked to fill in a questionnaire to assess any adverse events they may have experienced. At least 4-6 wk after the end of eradication therapy, eradication success was assessed using a 13C-urea breath test, and factors associated with eradication success were explored.
Herein, 103 patients were assessed, and 68 patients were finally included. All included patients had 1-3 previous eradication failures. The overall eradication rates calculated using intention-to-treat and per-protocol analyses were 92.6% (63/68) and 92.3% (60/65), respectively. The eradication rate did not differ with the number of treatment failures (P = 0.433). The rates of clarithromycin, metronidazole, and levofloxacin resistance were 91.3% (21/23), 100.0% (23/23), and 60.9% (14/23), respectively. There were no cases of resistance to tetracycline, amoxicillin, or furazolidone. In 60.9% (14/23) patients, the H. pylori isolate was resistant to all 3 antibiotics (clarithromycin, metronidazole, and levofloxacin); however, eradication was achieved in 92.9% (13/14) patients. All patients showed metronidazole resistance, and had an eradication rate of 91.3% (21/23). The eradication rate was higher among patients without anxiety (96.8%) than among patients with anxiety (60.0%, P = 0.025). No severe adverse events occurred; most adverse events were mild and disappeared without intervention. Good compliance was seen in 95.6% (65/68) patients. Serological examination showed no significant changes in liver and kidney function.
VAS is a safe and effective rescue therapy, with an acceptable eradication rate (> 90%), regardless of the number of prior treatment failures. Anxiety may be associated with eradication failure.
Core Tip: Vonoprazan (VPZ)-containing triple therapies have been shown to contribute to global antimicrobial resistance, while Saccharomyces boulardii (S. boulardii) supplementation has significantly improved Helicobacter pylori eradication rates and decreased adverse events. This study revealed that the VPZ and amoxicillin dual regimen with S. boulardii supplementation is safe and effective H. pylori rescue therapy, regardless of the number of prior treatment failures. Acceptable eradication rates (> 90%) were achieved in patients with resistance to clarithromycin, metronidazole, and levofloxacin. However, the regimen may need to be adjusted for patients with anxiety.