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Fourteen-day vonoprazan-based dual therapy with amoxicillin as first-line Helicobacter pylori treatment in comparison
Te-Ling Ma1, Chun-Ying Huang1, Chen-Ya Kuo2
1Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu Jen Catholic University Hospital, New Taipei City, Taiwan.
Background And Aim:
Proton pump inhibitor-based therapies remain the mainstream standard for Helicobacter pylori (H. pylori) eradication because of their lower cost and accessibility. Among these, 14-day sequential therapy (S-14) is a widely established and effective regimen with a relatively lower pill burden. Recently, 14-day vonoprazan-amoxicillin dual therapy (VA-14) has emerged as a promising alternative with similar therapeutic advantages. This study compared the efficacy and safety of VA-14 versus S-14 as first-line therapy.
Methods:
This single-center, prospective, randomized, non-inferiority trial enrolled 337 treatment-naïve adults. Participants were assigned to VA-14 (vonoprazan 20 mg plus amoxicillin 1000 mg twice daily for 14 days) or S-14 (lansoprazole 30 mg plus amoxicillin 1000 mg twice daily for 7 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 7 days). The primary endpoint was eradication rate assessed by urea breath test. Secondary outcomes included adverse events (AEs) and adherence.
Results:
Intention-to-treat eradication rates were 83.9% with VA-14 and 74.0% with S-14. Per-protocol rates were 90.9% and 85.6%, respectively, demonstrating non-inferiority (P < 0.001). AEs were significantly less frequent with VA-14 (42.8% vs 78.3%, P < 0.01), including severe AEs (4.2% vs 14.3%, P < 0.01). Full adherence was higher with VA-14 (93.8% vs 90.0%, P = 0.04).
Conclusions:
Fourteen-day vonoprazan-amoxicillin dual therapy is non-inferior to sequential therapy for first-line H. pylori eradication and offers better tolerability and adherence, representing a simplified and viable low pill burden option.
Clinical Trial Registration:
ClinicalTrials.gov, identifier NCT06156085.
Insights
Vonoprazan-amoxicillin dual therapy (VA-14) is as effective as sequential therapy (S-14) for H. pylori eradication. VA-14 showed better tolerability and adherence, offering a simplified treatment option.
Area of Science:
- Gastroenterology
- Infectious Diseases
- Pharmacology
Background:
- Proton pump inhibitor-based therapies are standard for H. pylori eradication.
- 14-day sequential therapy (S-14) is established but has a higher pill burden.
- 14-day vonoprazan-amoxicillin dual therapy (VA-14) is a newer alternative.
Purpose of the Study:
- To compare the efficacy and safety of VA-14 versus S-14 as first-line H. pylori eradication therapy.
- To evaluate eradication rates, adverse events, and adherence between the two regimens.
Main Methods:
- A single-center, prospective, randomized, non-inferiority trial.
- 337 treatment-naïve adults were randomized to VA-14 or S-14 for 14 days.
- Eradication assessed by urea breath test; adverse events and adherence were secondary outcomes.
Main Results:
- Intention-to-treat eradication rates: 83.9% for VA-14 vs. 74.0% for S-14.
- Per-protocol rates: 90.9% for VA-14 vs. 85.6% for S-14 (non-inferior).
- VA-14 had significantly fewer adverse events (42.8% vs. 78.3%) and higher adherence (93.8% vs. 90.0%).
Conclusions:
- 14-day vonoprazan-amoxicillin dual therapy is non-inferior to sequential therapy for H. pylori eradication.
- VA-14 offers improved tolerability and adherence compared to S-14.
- VA-14 is a simplified, viable option with a low pill burden for H. pylori treatment.
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