Efficacy and safety of a new rifabutin‐based triple therapy with vonoprazan for refractoryHelicobacter pyloriinfection: A prospective single‐arm study

Abstract

Background A small proportion of Helicobacter pylori‐infected individuals in Japan suffer failure of eradication therapy with third‐line regimens containing the potent acid suppressor, vonoprazan, and a quinolone. Objectives This prospective study evaluated the efficacy and safety of rifabutin‐based triple therapy with vonoprazan for refractory H pylori infection. Methods Patients who failed H pylori eradication by clarithromycin‐based first‐line, metronidazole‐based second‐line, and sitafloxacin‐based third‐line therapies were recruited. After obtaining informed consent, patients received eradication therapy with vonoprazan (20 mg), amoxicillin (750 mg), and rifabutin (150 mg) twice daily for 10 days. Eradication was confirmed by a negative H pylori stool antigen or urea breath test at least 8 weeks after the end of therapy. Results Nineteen patients were included in the study. All of the patients completed the course of medication. Eradication of H pylori was confirmed in all of the patients (19/19; 100%, 95% confidence interval; 83‐100%). The most common adverse event was soft stool/diarrhea (4/19, 21%). No severe adverse event was observed. Conclusions Ten‐day rifabutin with amoxicillin and vonoprazan triple therapy appears to be effective and safe for refractory H pylori infections. However, considering the recent publications showing high eradication rates with vonoprazan amoxicillin dual therapy, confirmation will require future studies comparing our new therapy with vonoprazan‐amoxicillin dual with similar doses and duration and with vonoprazan‐rifabutin dual therapy.

Rifabutin for the Treatment of Helicobacter pylori Infection: A Review

“…Finally, for the present review, to the best of our knowledge the most updated in the literature, all the studies that have evaluated the efficacy of rifabutin-containing regimens for the treatment of H. pylori infection are summarized in Table 2 [19,20,36,39,41,47,48,51,52,57,[67][68][69]77,78,. Overall, from the 3052 patients treated with rifabutin-containing regimens included in Table 2, a mean H. pylori eradication rate (by intention-to-treat analysis) of 73% (95% confidence interval (CI), 69-78%) was calculated (Figure 3).…”

“…In this same line, studies on rifabutin-based regimens with a potassium-competitive acid blocker such as vonoprazan instead of PPIs may additionally improve the success of the rifamycin-containing eradication therapy. In a recent study, patients who failed H. pylori eradication by clarithromycin-based first-line, metronidazole-based second-line, and sitafloxacin-based third-line therapies were prescribed vonoprazan (20 mg), amoxicillin (750 mg), and rifabutin (150 mg) twice daily for 10 days, and H. pylori eradication was confirmed in all patients (19/19; 100%) [78].…”

Sitafloxacin for Third-Line Helicobacter pylori Eradication: A Systematic Review

“…Sitafloxacin-based therapy should be used for sitafloxacin susceptible or gyrA mutation-negative H. pylori. Sitafloxacin resistant or gyrA mutation-positive H. pylori would require alternate treatments such as rifabutin-based therapy [ 13 , 59 , 60 , 61 ].…”

Treatment Approach of Refractory Helicobacter pylori Infection: A Comprehensive Review

“…In a more recent study of 19 patients, vonoprazan was used as the acid-suppressant in the PAR regimen in patients with refractory H. pylori , demonstrating an eradication rate of 100%. 48 …”

“…In a more recent study of 19 patients, vonoprazan was used as the acid-suppressant in the PAR regimen in patients with refractory H. pylori, demonstrating an eradication rate of 100%. 48 Following the failure of 2 lines of therapy for refractory H. pylori, susceptibility testing for the underlying strain is recommended. The efficacy of culture-guided treatment of H. pylori has been widely studied.…”