Clinical trial: seven‐day vonoprazan‐ versus 14‐day proton pump inhibitor‐based triple therapy for first‐line Helicobacter pylori eradication

Summary Background One‐week triple therapy with vonoprazan is endorsed by Japanese guidelines as an alternative to proton pump inhibitor (PPI)‐based triple therapy for first‐line Helicobacter pylori eradication. This contrasts with Western guidelines recommending 2‐week PPI‐based triple therapy. Aim To verify the non‐inferiority of 1‐week vonoprazan‐based triple therapy versus 2‐week PPI‐based triple therapy as first‐line H. pylori eradication in a multiracial Asian cohort. Methods Randomised controlled trial of treatment‐naïve patients with H. pylori infection assigned 1:1 to either 7 days amoxicillin 1 g + clarithromycin 500 mg + vonoprazan 20 mg twice per day or 14 days amoxicillin 1 g + clarithromycin 500 mg + omeprazole OR esomeprazole OR rabeprazole 20 mg twice/day. Subjects were randomly assigned to each PPI 1:1:1 Demographics, H. pylori resistance, CYP 2C19 genotype, eradication success and safety profiles were compared between groups. Results Between June 2019 and June 2021, 252 of 1097 subjects screened were randomised. 244 (age [SD] 51.7 [14.6]) received vonoprazan‐ ( n = 119) or PPI‐based ( n = 125) triple therapy. Eradication rates by intention‐to‐treat analysis were 87.4% (vonoprazan‐based triple therapy) versus 88.0% (PPI‐based triple therapy. By per protocol analysis: 96.3% (vonoprazan‐based triple therapy) versus 94.0% (PPI‐based triple therapy). Clarithromycin resistance predicted treatment failure on multivariate analysis: RR 11.4; 95% CI [1.4–96.3], p = 0.025. No significant differences in CYP 2C19 genotypes or adverse events occurred between groups. Conclusion One‐week vonoprazan‐based triple therapy achieved comparable efficacy to 2‐week PPI‐based triple therapy and was well tolerated.