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Background <p>Treatment failure of three standard regimens for <i>Helicobacter pylori</i> infections&#xa0;has increased and represents a significant challenge. The VAS regimen, consisting of vonoprazan, amoxicillin, and sitafloxacin, represents a promising treatment option, supported by its strong acid suppression and broad-spectrum antimicrobial activity.</p> Objectives <p>To evaluate the efficacy and safety of the VAS regimen as the fourth-line regimen for refractory <i>H. pylori</i> infection.</p> Methods <p>This prospective single-arm study involved patients with <i>H. pylori</i> infection who had failed three standard regimens. Participants received VAS regimen; comprising vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and sitafloxacin 100 mg twice daily for 7 days. Genotypic resistance was identified and CYP2C19 and CYP3A5 were studied. Eradication success was assessed using the 13C-urea breath test at 4-8 weeks post-therapy.</p> Results <p>Twenty patients (mean age 64.4 ± 8.6 years) were enrolled. The eradication rate was 70.0% (95% confidence interval (CI): 45.7–88.1) in the intention-to-treat analysis and 68.42% (95% CI: 43.5–87.4) in the per-protocol analysis. Notably, genotypic resistance demonstrated 93.9% and 85.7% of levofloxacin and clarithromycin resistance respectively. Mild adverse events were reported by three patients (15%), including loose stools, nausea, and bloating. Neither antibiotic resistance nor CYP2C19 and CYP3A5 rapid metabolizer status was associated with eradication failure.</p> Conclusion <p>The seven-day VAS regimen was well tolerated and demonstrated acceptably good efficacy as the fourth-line treatment for refractory <i>H. pylori </i>infection. The regimen offers a reasonably viable empirical rescue when lack of antibiotic susceptibility testing.</p> Trial registration <p>Thai Clinical Trials Registry (Identifier: TCTR20211203002, December 3, 2021).</p>

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Efficacy of a 7-day vonoprazan, sitafloxacin, and amoxicillin triple therapy as a fourth-line salvage regimen for refractory Helicobacter pylori infection

  • 期刊论文

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  • 发表日期：

    2025年9月26日

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  • Tanawat Geeratragool,
  • Supathep Tansirichaiya,
  • Witchuda Kamolvit,
  • Thanapat Atthakitmongkol,
  • Wasawat Leartsiwawinyu,
  • Iyarit Thaipisuttikul,
  • Pritsana Chuenprapai,
  • Somchai Leelakusolvong,
  • Chanin Limwong,
  • Monthira Maneerattanaporn

摘要

Background

Treatment failure of three standard regimens for Helicobacter pylori infections has increased and represents a significant challenge. The VAS regimen, consisting of vonoprazan, amoxicillin, and sitafloxacin, represents a promising treatment option, supported by its strong acid suppression and broad-spectrum antimicrobial activity.

Objectives

To evaluate the efficacy and safety of the VAS regimen as the fourth-line regimen for refractory H. pylori infection.

Methods

This prospective single-arm study involved patients with H. pylori infection who had failed three standard regimens. Participants received VAS regimen; comprising vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and sitafloxacin 100 mg twice daily for 7 days. Genotypic resistance was identified and CYP2C19 and CYP3A5 were studied. Eradication success was assessed using the 13C-urea breath test at 4-8 weeks post-therapy.

Results

Twenty patients (mean age 64.4 ± 8.6 years) were enrolled. The eradication rate was 70.0% (95% confidence interval (CI): 45.7–88.1) in the intention-to-treat analysis and 68.42% (95% CI: 43.5–87.4) in the per-protocol analysis. Notably, genotypic resistance demonstrated 93.9% and 85.7% of levofloxacin and clarithromycin resistance respectively. Mild adverse events were reported by three patients (15%), including loose stools, nausea, and bloating. Neither antibiotic resistance nor CYP2C19 and CYP3A5 rapid metabolizer status was associated with eradication failure.

Conclusion

The seven-day VAS regimen was well tolerated and demonstrated acceptably good efficacy as the fourth-line treatment for refractory H. pylori infection. The regimen offers a reasonably viable empirical rescue when lack of antibiotic susceptibility testing.

Trial registration

Thai Clinical Trials Registry (Identifier: TCTR20211203002, December 3, 2021).