Vonoprazan-amoxicillin combo on par with B-quadruple therapy for H. pylori infection

Ten-day treatment with vonoprazan 20 mg twice/day plus amoxicillin 750 mg four times/day (VHA-dual) as a first-line therapy for Helicobacter pylori infection results in satisfactory eradication rate of >90 percent, fewer adverse events (AEs), and similar adherence when compared with bismuth quadruple therapy (B-quadruple), results of a study have shown.

On the other hand, treatment with vonoprazan 20 mg plus amoxicillin 1,000 mg twice/day (VA-dual) falls short of achieving an acceptable efficacy.

The investigators conducted this randomized controlled trial to assess the efficacy and safety of 10-day vonoprazan-amoxicillin dual therapy as a first-line treatment of H. pylori infection compared with B-quadruple and to determine the ideal dosage of amoxicillin in the dual therapy.

In total, 375 treatment-naïve, H. pylori-infected patients were randomized 1:1:1 into the following regimens: VHA-dual, VA-dual, or B-quadruple. The investigators then compared the eradication rates, AEs, and compliance across the three groups.

Per-protocol analysis revealed eradication rates of 93.4 percent with VHA-dual therapy, 90.9 percent with B-quadruple, and 85.1 percent with VA-dual. By modified intention-to-treat analysis, the rates were 92.7 percent, 89.4 percent, and 84.4 percent, respectively, while the corresponding rates by intention-to-treat analysis were 91.2 percent, 88.0 percent, and 82.4 percent.

The efficacy of the VHA-dual therapy was not inferior to the B-quadruple therapy (p<0.001), but VA-dual failed to reach the noninferiority margin of ‒10 percent.

Notably, the B-quadruple group had significantly higher AE rates than the VHA-dual (p=0.012) and VA-dual (p=0.001) groups. No significant difference was observed in medication compliance among the three treatment groups (p=0.995).