DDW 2024: Vonoprazan Dual and Triple Therapy versus Bismuth-quadruple Therapy as First-line Therapy for Helicobacter Pylori Infection
The study compared vonoprazan dual and triple therapies with bismuth quadruple therapy for H. pylori treatment in China, where the disease remains prevalent at a rate of 43%. Although bismuth quadruple therapy is a recommended first-line treatment, it has significant limitations, including high side effects, limited availability of certain components like tetracycline and bismuth, and a suboptimal eradication rate of 83%. Conversely, vonoprazan-based dual therapy, which includes clarithromycin and amoxicillin, demonstrates higher efficacy, particularly in areas with high clarithromycin resistance, and aligns with antibiotic stewardship principles by avoiding unnecessary antibiotic usage. Recent meta-analyses of RCTs, primarily conducted in China, have compared dual therapy to Bismuth quadruple therapy, noting variations in the components used. Given the high clarithromycin resistance rate in China (approximately 40%), the components of Bismuth quadruple therapy may be less effective. The study's intention-to-treat analysis revealed that VA dual therapy achieved an 87% cure rate compared to 85% for Bismuth quadruple therapy.
A recent multicenter three-arm RCT from the West compared dual therapy, triple therapy, and PPI triple therapy for H. pylori treatment. Despite its relevance, PPI triple therapy is no longer recommended as first-line treatment due to high clarithromycin resistance rates in the West and Europe. This study addressed the gap by conducting an investigator-initiated three-arm non-inferiority RCT in Shenzhen, China, comparing VA dual therapy, VAC triple therapy, and classic Bismuth quadruple therapy. The study included newly diagnosed, treatment-naive adults confirmed with H. pylori infection. Conducted between 2022 and 2023, it excluded patients allergic to study drugs, those with previous stomach surgery, or recent antibiotic/PPI use. Patients received 14 days of treatment and were assessed at one, two and four weeks post-treatment, with the primary outcome measured by urea breath test at six weeks. The COVID-19 pandemic limited the collection of biopsies or stool samples for resistance profiling. The study enrolled 296 patients: 100 in the dual therapy group, 98 in the triple therapy group, and 100 in the Bismuth quadruple therapy group. Baseline characteristics were similar across groups, with an overall mean age of 35.7 years. H. pylori eradication rates exceeded 95% for both dual and triple therapies, and 92% for Bismuth quadruple therapy, showing non-inferiority of dual and triple therapies compared to Bismuth quadruple therapy. Adverse events were lower in the dual therapy group, and treatment compliance was higher in both VA groups compared to bismuth quadruple therapy, which had a compliance rate of 79% for the full 14-day course.
The study's limitations include being single-center and lacking extensive antibiotic susceptibility testing, though this is less relevant for the vonoprazan and amoxicillin dual therapy due to low resistance rates (1-3%). The non-inferiority design may not generalize to Western populations. In conclusion, the 14-day vonoprazan dual therapy is preferable to the 14-day triple therapy and classic Bismuth quadruple therapy as a first-line treatment in southern China, given its high eradication rate (over 90%), fewer adverse events, and reduced antibiotic use, aligning with antibiotic stewardship principles.
Digestive Disease Week (DDW) 2024, May 18-21, 2024, Washington, D.C.
