Rifasutenizol tackles H. pylori infection

Rifasutenizol demonstrates efficacy in the treatment of Helicobacter pylori infection, according to the results of the phase III EVEREST-HP trial.

Conducted in China, EVEREST-HP included 700 adult patients (63 percent female) with H. pylori infection, as confirmed by urea breath test, gastric biopsy, and histological examination. These patients were randomly assigned to receive rifasutenizol 400 mg plus amoxicillin 1 g and rabeprazole 20 mg (RTT, n=353) or bismuth potassium citrate 240 mg plus clarithromycin 500 mg, amoxicillin 1 g, and rabeprazole 20 mg (BCTT, n=347). Treatment was administered twice a day for 14 days.

The primary endpoint was H. pylori eradication rate based on urea breath test 4–6 weeks after the end of treatment. Safety endpoints included investigator-assessed treatment-emergent adverse events (TEAEs), the severity and relationship with study drugs, findings from physical examinations, vital signs, laboratory tests, and electrocardiogram.

The modified intention-to-treat population included 351 patients in the RTT group and 346 in the BCTT group who took at least one dose of the study drugs. H. pylori was successfully cultured from 83 percent of patients overall. Antibiotic resistance was identified; 68 percent of patients had an infection resistant to metronidazole, 41 percent to clarithromycin, 35 percent to levofloxacin, and 8 percent to amoxicillin. All H. pylori clinical isolates were susceptible to rifasutenizol.

The H. pylori eradication rate in the RTT group was noninferior to that in the BCTT group (92 percent vs 87.9 percent). TEAEs occurred in 37 percent of patients in the RTT group and 53 percent in the BCTT group. The most common TEAEs were diarrhoea (7 percent), nausea (6 percent), and dizziness (6 percent) in the RTT group; and taste perversion (36 percent), nausea (6 percent), and diarrhoea (5 percent) in the BCTT group. These TEAEs were mostly mild or moderate in severity. There were no reports of serious adverse event related to the study drugs.