Efficacy and Safety of Vonoprazan-Amoxicillin Dual Therapy for Helicobacter pylori Infection Among People Living With HIV.

BACKGROUND

Antiretroviral therapy (ART) has significantly increased the life expectancy of people living with human immunodeficiency virus (PLWH), resulting in a growing need for the treatment of Helicobacter pylori infections in this population. H. pylori treament among PLWH who are on ART can be challenging due to potential drug-drug interactions (H. pylori eradication drugs interact with ART drugs). This study aimed to evaluate the efficacy and safety of vonoprazan-amoxicillin (VA) dual therapy for H. pylori infection among PLWH.

METHODS

A total of 201 treatment-naive, H. pylori--positive PLWH on ART were enrolled to receive vonoprazan (20 mg twice daily) plus amoxicillin (1000 mg 3 times daily) for 14 days. H. pylori eradication status was assessed using the urease breath test ≥4 weeks after treatment. Patient compliance and adverse events (AEs) were recorded.

RESULTS

Of the 201 participants, 181 (90.0%) completed the treatment course. Nineteen patients were lost to follow-up, and 1 discontinued treatment due to a rash. The eradication rates were 74.6% (150 of 201) by intention-to-treat analysis, 82.9% (150 of 181) by modified intention-to-treat analysis, and 90.6% (145 of 160) by per-protocol analysis. AEs occurred in 10 patients (5.0%), including abdominal distension in 5 and abdominal pain, nausea, diarrhea, fatigue, and rash, each occurring in 1 patient. Most AEs were mild and resolved spontaneously after treatment. Good compliance (odds ratio, 1.03 [95% confidence interval, 1.01-1.11]; P < .001) was independently associated with the efficacy of VA for H. pylori eradication.

CONCLUSIONS

VA dual therapy as a first-line treatment for H. pylori infection among PLWH on ART demonstrates good efficacy and safety.

CLINICAL TRIALS REGISTRATION: ChiCTR2400085762.