Vonoprazan-based triple and dual regimens effective for treatment of H.pylori infection

USA: Vonoprazan triple therapy and dual therapy, both regimens were superior to PPI-based triple therapy in clarithromycin-resistant strains and in the overall study population with Helicobacter pylori infection finds a randomized, controlled, phase 3 trial conducted in US and Europe.

The results of the trial have been published in Gastroenterology. 

Approximately 50 percent of the world's population has been estimated to be infected by Helicobacter pylori, which is the leading cause of the peptic ulcer, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue lymphoma. Guidelines recommend H. pylori eradication whenever identified.

For several decades, the treatment landscape for H. pylori infection has been dominated by proton pump inhibitor (PPI)-based triple therapy but eradication rates have dropped, mainly due to rising rates of clarithromycin resistance. Hence, there is a pressing need to optimize management. Vonoprazan is a potassium-competitive acid blocker, currently approved for the treatment of H. pylori infection and other acid-related diseases in several countries. Vonoprazan could therefore enhance H. pylori therapy by optimizing gastric acid suppression and antimicrobial activity.

William D., Division of Gastroenterology and Hepatology, Michigan Medicine, USA, and colleagues conducted the trial to compare the efficacy and adverse events of vonoprazan triple and dual therapy to PPI-based triple therapy for the eradication of H. pylori

The study was a multicenter, randomized, clinical trial conducted at multiple sites in the US and Europe. 1,046 patients with H. pylori infection were randomized 1:1:1 to open-label vonoprazan dual therapy (20mg vonoprazan twice daily [BID]; 1g amoxicillin three times daily), or double-blind triple therapy BID (vonoprazan 20mg or lansoprazole 30mg; amoxicillin 1g; clarithromycin 500mg) for 14 days.

The primary outcome was non-inferiority in eradication rates in patients without clarithromycin- and amoxicillin-resistant strains (non-inferiority margin=10%). Secondary outcomes assessed superiority in eradication rates in clarithromycin-resistant infections and in all patients.

Trial data showed,

• Eradication rates in non-resistant strains: vonoprazan triple therapy 84.7%, dual therapy 78.5%, versus lansoprazole triple therapy 78.8%

• Eradication rates in clarithromycin-resistant infections: vonoprazan triple therapy 65.8%, dual therapy 69.6%, versus lansoprazole triple therapy 31.9%.

• In all patients, vonoprazan triple and dual therapy was superior to lansoprazole triple therapy.

• The overall frequency of treatment-emergent adverse events was similar between vonoprazan and lansoprazole regimens.

The authors conclude that vonoprazan-based triple and dual regimens were non-inferior to lansoprazole-based triple therapy for eradication of H. pylori strains not resistant to clarithromycin and amoxicillin.

In pre-determined secondary analyses, vonoprazan triple and dual regimens were superior to lansoprazole-based triple therapy in patients with clarithromycin-resistant strains and in the overall study population

The study findings support the consideration of vonoprazan-based regimens for the treatment of H. pylori infection, the authors wrote.

Reference:

 Chey WD, Mégraud F, Laine L, López LJ, Hunt BJ, Howden CW, Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the US and Europe: Randomized Clinical Trial, Gastroenterology (2022), doi: https://doi.org/10.1053/j.gastro.2022.05.055.