Vonoprazan-Tetracycline Dual Regimen as Rescue Therapy for Helicobacter pylori Infection: Randomized Controlled Trial.

BACKGROUND & AIMS: Treatment of Helicobacter pylori infection after previous eradication failure remains challenging. This study evaluated the efficacy and safety of a vonoprazan-tetracycline (VT) dual regimen as a potential rescue therapy.

METHODS

In this prospective, open-label, randomized controlled trial, H pylori-positive adults with at least 1 prior eradication failure were allocated 1:1 to VT dual therapy (vonoprazan [20 mg, twice a day] and tetracycline [500 mg, 3 times a day]), or bismuth quadruple therapy (BQT; lansoprazole [30 mg, twice a day], colloidal bismuth [150 mg, 3 times a day], tetracycline [500 mg, 3 times a day], and metronidazole [400 mg, 3 times a day]) for 14 days. The primary outcome was noninferiority in eradication rates between VT and BQT groups. Secondary outcomes assessed adverse effects in both groups.

RESULTS

Of 350 randomized patients (175 per group), the eradication rates in the VT dual-therapy group and the BQT group were, respectively, 90.6% (154 of 170; 95% confidence interval [CI], 84.9%-94.4%) and 89.3% (151 of 169; 95% CI, 83.5%-93.4%) in modified intention-to-treat analysis (difference, 1.2%; 95% CI,-5.7% to 8.2%; noninferiority P = .0003), 91.1% (153 of 168; 95% CI, 85.4%-94.7%) and 92.2% (141 of 153; 95% CI, 86.4%-95.7%) in per-protocol analysis (difference, -1.1%; 95% CI, -7.8% to 5.6%; noninferiority P = .002), meeting the noninferiority criterion (P < .0125). Treatment-emergent adverse events were less frequent with dual therapy (10.9% vs 45.7%; P < .001), and no patient discontinued because of adverse events (0.0% vs 8.6%; P < .001). Adherence was higher with dual therapy (96.0% vs 87.4%; P = .006).

CONCLUSIONS

VT dual therapy for 14 days is an effective and well-tolerated rescue regimen for H pylori infection. This simplified regimen achieved eradication rates noninferior to BQT while substantially reducing adverse events and improving adherence. Chinese Clinical Trial Registry: ChiCTR2400080705 (chictr.org.cn,).