Vonoprazan for H pylori Eradication Is Safe and Efficacious in Adolescents

Vonoprazan eradication therapy for H pylori infection is as safe and efficacious in adolescent patients as in adults.

A vonoprazan-based regimen for Helicobacter pylori (H pylori) infection is safe and efficacious for adolescents when used for primary and secondary eradication therapy, according to a study in the Journal of Gastroenterology.

Researchers evaluated the efficacy and safety of a vonoprazan-based regimen for H pylori eradication therapy in junior high school students in Japan beginning in 2016.

Participants’ urine samples were screened for anti-H pylori immunoglobulin G antibody using immunochromatography. Students who had a positive urine antibody test then had a stool antigen test. Those who tested positive on the urine and fecal tests were invited to attend a cooperating medical institution when they were 15 years old.

Attending physicians initially provided data on adverse events, but in 2017 the students began to record their adverse events on a checklist. The students reported diarrhea, fever, abdominal pain, nausea, vomiting, urticaria, dysgeusia, or bloody stools during the eradication treatment. Researchers examined students who participated in H pylori screening and treatment from April 2017 to March 2022.

A total of 36,744 students were tested for urinary anti-H pylori antibodies, of whom 1316 students had a positive antibody test. Of those, 836 (median age, 15.7 years; male, 443) students also had a positive stool antigen test.

Of the 645 students who were evaluated, 542 (84.0% [95% CI, 85.8-91.9] in the per-protocol [PP] analysis and 73.6% [95% CI, 85.8-91.9] in the intention-to-treat [ITT] analysis) had successful primary eradication therapy.

The success ratio (84.1%) of the VPZ-based regimen of H pylori eradication in the present study was equivalent to that reported elsewhere for adults (u003e90%).

Among the 82 students who had secondary eradication therapy, 79 (96.3% [95% CI, 86.4-99.8]) in the PP analysis and 76.7% (95% CI, 85.8-91.9) in the ITT analysis had successful eradication.

A total of 588 students who had primary eradication therapy and 62 with secondary eradication therapy submitted checklists for adverse events. In those with primary eradication therapy, abdominal pain occurred in 164 (27.9%) students, diarrhea in 217 (36.9%), nausea or vomiting in 7 (1.2%), and urticaria in 13 (2.2%). In students who had secondary eradication therapy, abdominal pain occurred in 12 (19.4%) participants and diarrhea in 17 (27.4%). Eradication therapy was interrupted in 5 students owing to adverse events in those with primary eradication therapy.

Study limitations include a small geographical area of children, difficulty conducting a comparative study, and an inability to perform susceptibility testing. Student dropouts also occurred, including untreated students, and the study authors were unable to assess the status of a student who was positive for H pylori antibodies in urine and negative for antigens in stool.

“The success ratio (84.1%) of the VPZ-based regimen of H pylori eradication in the present study was equivalent to that reported elsewhere for adults (>90%),” the study authors wrote.

This article originally appeared on Gastroenterology Advisor

References:

Kakiuchi T, Matsuo M, Endo H, et al. Efficacy and safety of vonoprazan-based regimen for Helicobacter pylori eradication therapy in Japanese adolescents: a prospective multicenter study. J Gastroenterol. Published online December 17, 2022. doi:10.1007/s00535-022-01942-z