Rifasutenizol-Based Triple Therapy Shows Non-Inferiority and Improved Tolerability in H. pylori Eradication
A phase 3 randomized controlled trial has demonstrated that rifasutenizol-based triple therapy (RTT) is non-inferior to bismuth plus clarithromycin-based triple therapy (BCTT) in eradicating Helicobacter pylori infection among treatment-naive adults. The findings support rifasutenizol as a novel therapeutic option with a favorable safety profile, particularly amid growing antibiotic resistance.
In the modified intention-to-treat analysis of 697 participants, the eradication rate for RTT was 92.0% (95% CI, 88.7–94.6) compared with 87.9% for BCTT (95% CI, 83.9–91.1), meeting the non-inferiority margin. “RTT represents a promising first-line treatment option for H. pylori infection,” the authors stated.
Importantly, all H. pylori clinical isolates were susceptible to rifasutenizol, while resistance rates for clarithromycin, metronidazole, and levofloxacin were 41%, 68%, and 35%, respectively. This highlights the potential of rifasutenizol in settings with high resistance to commonly used antibiotics.
RTT was also associated with a lower incidence of treatment-emergent adverse events than BCTT (37% vs 53%). The most frequent adverse events in the RTT group were diarrhea (7%), nausea (6%), and dizziness (6%), while BCTT was more commonly associated with taste perversion (36%).
“No serious adverse event related to study drugs was reported,” the authors noted, further supporting the tolerability of RTT.
For gastroenterologists, these results suggest that rifasutenizol could serve as a well-tolerated and effective first-line therapy, particularly in populations with high rates of clarithromycin resistance. The dual mechanism of action and resistance profile of rifasutenizol mark it as a promising agent in the evolving landscape of H. pylori treatment.
Reference
Song Z, Zhou L, Wang W, et al. Rifasutenizol-based triple therapy versus bismuth plus clarithromycin-based triple therapy for first-line treatment of Helicobacter pylori infection in China (EVEREST-HP): a phase 3, multicentre, randomised, triple-dummy, double-blind, controlled, non-inferiority trial. The Lancet Infectious Diseases. Published online September 1, 2025. doi:https://doi.org/10.1016/s1473-3099(25)00438-4
