Real-World Observational Clinical Study Assessing the Effectiveness and Safety of Vonoprazan-Based Dual Therapy...

Helicobacter pylori (H. pylori) is a gram-negative bacterium linked to various gastrointestinal disorders. Our study evaluates the comparative effectiveness, safety, and cost-efficiency of vonoprazan-amoxicillin (VA) dual therapy as an alternative to traditional proton pump inhibitor (PPI)-based triple therapy for eradicating H. pylori.

This real-world, observational, single-center clinical study used medical records of 94 adult patients diagnosed with H. pylori infection in India between July 2024 to March 2025. The patients received 14 days of VA dual therapy or PPI-amoxicillin-clarithromycin (PAC) triple therapy. The primary outcome included H. pylori eradication using a repeat rapid urease test, and the secondary outcomes included the need for rescue therapy, time for symptom resolution, incidence of adverse drug reactions, and cost-comparison of the treatment regimens.

Eradication rates were numerically higher with VA than PAC (93.33% vs. 85.71%), although the difference was not statistically significant. As second-line therapy, eradication was achieved in 100% of PAC-to-VA switchers and 33.3% of VA-to-PAC switchers. Symptom resolution was significantly earlier with VA compared to PAC (median, 3 vs. 5 days; P < 0.001). Adverse events were fewer with VA (13.33%) than PAC (28.57%), with taste disturbances more frequent in the PAC group. VA also showed a significantly lower median treatment cost (Indian rupee (INR) 1,020 (US dollar (USD) 12.29) vs. INR 3,380 (USD 40.72); P <0.001) and a better cost-comparison ratio (10.67 vs. 39.43).

VA showed numerically higher eradication rates, faster symptom relief, lower costs, and better tolerability than PAC in the Indian setting, supporting its potential as a practical alternative first-line regimen, particularly in settings where clarithromycin resistance is prevalent or suspected.