Safety of high-dose dual therapy for Helicobacter pylori eradication in patients with varying degrees of metabolic associated fatty liver disease.

OBJECTIVES

To evaluate the safety and efficacy of high-dose dual therapy (HDDT) for Helicobacter pylori (H. pylori) eradication in patients with varying degrees of metabolic associated fatty liver disease (MAFLD).

METHODS

A total of 91 patients diagnosed with MAFLD complicated by H. pylori infection at the Department of Gastroenterology, Beijing Jishuitan Hospital, Capital Medical University, from October 2024 to December 2025, were enrolled. Based on liver transient elastography (FibroTouch) results, patients were divided into mild (n = 40), moderate (n = 28), and severe (n = 23) fatty liver groups. All patients received a 14-day HDDT regimen (vonoprazan fumarate 20 mg/dose, twice daily; amoxicillin 1.0 g/dose, three times daily). The primary outcome measure was changes in liver function (ALT, AST, GGT, ALP) before treatment and at treatment completion; secondary outcome measures were H. pylori eradication rate and incidence of adverse reactions.

RESULTS

Baseline ALT levels increased with the severity of fatty liver (mild 29.95 ± 16.90 U/L, moderate 38.24 ± 22.75 U/L, severe 49.63 ± 19.90 U/L, p < 0.01). At treatment completion, ALT and AST levels showed an increasing trend in patients with mild and moderate fatty liver but a decreasing trend in patients with severe fatty liver; however, none of the differences were statistically significant (p > 0.05). A total of 2 cases (2.2%) experienced transient mild elevation of transaminases (<2 times the upper limit of normal), which resolved spontaneously after drug discontinuation, and no grade 2 or higher drug-induced liver injury occurred. The eradication rates (ITT) in the three groups were 92.50%, 89.29%, and 91.30%, respectively, with no statistically significant difference between groups (p > 0.05). The total incidence of adverse reactions was 23.08%, mainly mild gastrointestinal symptoms such as bloating and nausea, with no serious adverse events.

CONCLUSIONS

HDDT demonstrates good hepatic safety and high eradication rates in patients with mild to severe MAFLD who have mildly elevated liver enzymes. It can be recommended as a treatment option for H. pylori eradication in this patient population, but monitoring of liver function changes is advised.