Vonoprazan With High-Dose Amoxicillin Viable as First-Line H pylori Therapy

Vonoprazan plus high-dose amoxicillin was associated with a similar eradication rate and superior safety profile compared with B-quadruple therapy for H pylori infection.

A 10-day vonoprazan plus high-dose amoxicillin regimen has noninferior eradication rates and lower adverse event rates compared with bismuth-containing quadruple therapy as a first-line treatment for Helicobacter pylori (H pylori)infection. These study findings were published in The American Journal of Gastroenterology.

Researchers conducted a single-center, open-label, randomized, parallel-controlled study between 2021 and 2022 at Nanjing Medical University in China. Patients (N=375) with newly-diagnosed H pylori were randomly assigned in a 1:1:1 ratio to receive either

  • Vonoprazan 20 mg twice daily plus amoxicillin 750 mg 4 times daily (VHA-dual; n=125);
  • Vonoprazan 20 mg plus amoxicillin 1000 mg twice daily (VA-dual; n=125); or
  • Amoxicillin 20 mg, colloidal bismuth pectin 200 mg, amoxicillin 1000 mg, and clarithromycin 500 mg twice daily (B-quadruple; n=125) for 10 days.

Safety and efficacy were compared between the 3 treatment strategies.

The VHA-dual, VA-dual, and B-quadruple therapy cohorts had a mean age 42.70, 41.04, and 43.30 years; the men to women ratios were 60:65, 63:62, and 59:66; and 26.4%, 27.2%, and 26.4% had H pylori-associated ulcer, gastritis, and/or neoplasia, respectively.

[T]he 10-day VHA-dual provided satisfactory eradication rates, lower overall AEs rates, and similar adherence compared with B-quadruple and is suitable as a first-line therapy for H. pylori infection in regions with high resistance to clarithromycin.

Among the intention-to-treat (ITT) population, the eradiation rates were 91.2% for VHA-dual, 82.4% for VA-dual, and 88.0% for the B-quadruple therapies (P =.108). In the per-protocol (PP) analysis, eradication rates were 93.4%, 85.1%, and 90.9% (P =.089), respectively.

Compared with the B-quadruple regimen, the level of noninferiority was reached for the VHA-dual treatment in both the ITT (P <.001) and PP (P <.001) analyses whereas VA-dual did not in either the ITT (P =.163) or the PP (P =.155) analyses.

Fewer adverse events were reported by VHA-dual (11.4%) and VA-dual (8.2%) recipients compared with B-quadruple (23.6%) recipients (P =.001). The only specific adverse event rate that differed between treatment groups was abnormal taste, which was reported by 15.5% of the B-quadruple recipients and none of the VHA- or VA-dual recipients. The rate of moderate to severe adverse events did not differ between groups (range, 2.5%-4.9%).

The compliance rate was high in this study (range, 97.6%-99.2%).

This study may have been limited by not screening patients for antimicrobial susceptibility prior to treatment.

The results of this study indicated that vonoprazan plus high-dose amoxicillin was associated with a similar eradication rate and superior safety profile compared with B-quadruple therapy and should be considered as a viable first-line treatment option for H pylori.

The study authors conclude, “[T]he 10-day VHA-dual provided satisfactory eradication rates, lower overall AEs rates, and similar adherence compared with B-quadruple and is suitable as a first-line therapy for H. pylori infection in regions with high resistance to clarithromycin.”

References:

Qian H-S, Li W-J, Dang Y-N, et al. Ten-day vonoprazan-amoxicillin dual therapy as a first-line treatment of helicobacter pylori infection compared with bismuth-containing quadruple therapy. Am J Gastroenterol. Published online December 2, 2022. doi:10.14309/ajg.0000000000002086