Pilot studies of vonoprazan‐containing Helicobacter pylori eradication therapy suggest Thailand may be more similar to the US than Japan

Abstract

BackgroundVonoprazan‐containing Helicobacter pylori eradication is reliably effective in Japan. Its effectiveness in other countries remains unclear. Here, we examined vonoprazan‐H. pylori therapies in Thailand.Materials and MethodsThis was pilot study of four different vonoprazan containing therapies. Subjects were randomized to: 14‐day dual therapy (500 mg amoxicillin q.i.d. plus 20 mg vonoprazan b.i.d.), 14‐day triple therapy (amoxicillin 1 g b.i.d., slow release clarithromycin‐MR, 1 g daily plus vonoprazan 20 mg b.i.d.), 7‐day high‐dose vonoprazan triple therapy (amoxicillin 1 g b.i.d., clarithromycin‐MR 1 g daily and 60 mg vonoprazan once daily), and 14‐day vonoprazan triple therapy plus bismuth (amoxicillin 1 g b.i.d., clarithromycin‐MR 1 g daily, vonoprazan 20 mg b.i.d., and bismuth subsalicylate 1048 mg b.i.d.). Eradication was confirmed 4 weeks after therapy. Antimicrobial susceptibility and CYP3A4/5 genotyping were performed.ResultsOne hundred H. pylori‐infected patients (mean age 54.3 ± 13 years, 51% men) were randomized. All were CYP3A4 extensive metabolizers. Cure rates with both 14‐day vonoprazan dual therapy and 14‐day triple therapy were low: 66.7%; 95% CI = 43–85% (14/21), and 59.3%; 95% CI = 39–78%) (16/27), respectively. In contrast, 7‐day high‐dose vonoprazan triple therapy and 14‐day vonoprazan triple plus bismuth proved effective 92.3%; 95% CI = 75%–99% (24/26) and 96.2%; 95% CI = 80%–100% (25/26), respectively.ConclusionBoth 14‐day vonoprazan dual and triple therapy were ineffective for H. pylori eradication in Thailand. Higher dosage of vonoprazan, and/or the addition of bismuth may be required to achieve high H. pylori eradication rates. High‐dose vonoprazan triple therapy and vonoprazan triple therapy adding bismuth might be used as first‐line treatments in some regions with high efficacy irrespective of CYP3A4/5 genotype and clarithromycin resistance.

Vonoprazan‐amoxicillin dual therapy versus bismuth‐containing quadruple therapy for Helicobacter pylori eradication: A systematic review and meta‐analysis

“…After assessing the titles and abstracts, a further 138 records were excluded, leaving 20 articles to be retrieved for full‐text evaluation. In the end, six RCTs 18–23 fulfilled the inclusion criteria. Figure 1 displays a flow chart of the study selection process.…”

“…In total, 1233 patients were involved in six RCTs published in the year 2023. All studies, with the exception of the one in Thailand, 22 were conducted in China. Among these studies, there were two multicenter RCTs 18,20 and four single‐center RCTs 19,21–23 .…”

“…All studies, with the exception of the one in Thailand, 22 were conducted in China. Among these studies, there were two multicenter RCTs 18,20 and four single‐center RCTs 19,21–23 . The sample size spanned from 47 to 375.…”

“…With regard to the VA dual therapy, all the participants were prescribed 20 mg of vonoprazan twice a day, with the amoxicillin dosage ranging from 2000 to 3000 mg/day. Regarding BQT, five studies used PPI‐based BQT, and one study 22 used vonoprazan‐based BQT. For the duration of eradication regimen, only one RCT 21 is 10 days, while the rest are 14 days.…”

“…Recently, several randomized controlled trials (RCTs) 18–23 regarding VA dual therapy versus BQT for H. pylori eradication have been published in 2023, but the results were inconsistent and controversial. Hence, we performed a systematic review and meta‐analysis of RCTs to compare the effects of VA dual therapy with BQT for H. pylori eradication.…”