A 14-day course of hybrid therapy was as effective as 10-day bismuth quadruple therapy, but with fewer side effects, according to results of a randomized trial conducted in Taiwan.
“However, the former had fewer adverse events than the latter,” investigator Ping-I Hsu, MD, of An Nan Hospital, China Medical University, Taiwan said in a virtual presentation at the annual Digestive Disease Week® (DDW). Some patients in the trial received 14-day high-dose dual therapy, which also had a lower rate of adverse events but a lower eradication rate, compared with quadruple therapy, Hsu added.
This study confirms previous data showing that hybrid therapy has high eradication rates and a lower frequency of adverse events compared with bismuth quadruple therapy, noted Joseph Adrian L. Buensalido, MD, clinical associate professor of medicine in the division of infectious diseases at the University of the Philippines–Philippine General Hospital in Manila. “Clinicians and specialty/guideline groups may need to start looking at moving to first-line hybrid therapy as opposed to the traditional approach,” Buensalido said in an interview.
Current Guidelines and Data to Date
An American College of Gastroenterology clinical guideline published in 2017 strongly recommends bismuth quadruple therapy, with a duration of 10-14 days, as a first-line treatment option. Hybrid therapy is conditionally recommended as a first-line option in the ACG guideline, while high-dose dual therapy is conditionally recommended as a salvage regimen.
In a prospective, randomized comparative study published in 2017, the eradication rates (93.9%) in patients receiving 14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole) were comparable with eradication rates (92.8%) with 14-day hybrid therapy (dual therapy with pantoprazole plus amoxicillin for 7 days, followed by quadruple therapy with pantoprazole, amoxicillin, clarithromycin, and metronidazole for 7 days).
Quadruple therapy had a higher frequency of adverse events, at 55%, compared with 15.7% for hybrid therapy (P < .001). “Whether shortening the treatment duration of bismuth quadruple therapy from 14 days to 10 days can reduce the frequency of adverse effects remains unclear,” Hsu said in introductory comments to his study.
Comparing Three Approaches
In the multicenter, randomized, open-label superiority trial presented at DDW, Hsu and colleagues randomly assigned 600 Helicobacter pylori–infected participants in equal numbers to receive 14-day hybrid therapy, 14-day high-dose dual therapy, or 10-day bismuth quadruple therapy.
The hybrid therapy regimen consisted of rabeprazole 20 mg twice a day plus amoxicillin 1 g twice a day for 14 days, with clarithromycin 500 mg and metronidazole 500 mg twice a day in the final 7 days. The high-dose dual therapy regimen consisted of rabeprazole 20 mg and amoxicillin 750 mg four times a day for 14 days. The bismuth quadruple therapy regimen consisted of rabeprazole 20 mg twice a day, tripotassium dicitrato bismuthate 300 mg four times a day, tetracycline 500 mg twice a day, and metronidazole 250 mg four times a day for 10 days.
Investigators assessed H. pylori status 6 weeks following the end of therapy. In an intention-to-treat analysis, the hybrid therapy regimen yielded an eradication rate of 96.5%, which was comparable with the 93.5% eradication rate seen with bismuth quadruple therapy and was significantly higher than the 86.0% eradication rate seen with high-dose dual therapy (P < .001), according to Hsu. Similar efficacy outcomes were seen in per-protocol analysis.
The frequency of adverse events was lowest with high-dose dual therapy, at 13.0%, according to Hsu. That was significantly lower than the 25.5% frequency of adverse events with hybrid therapy. Bismuth quadruple therapy had a rate of 34.0%.
Antibiotic Resistance Results
Antibiotic resistance was most common for metronidazole, seen in approximately 28% of the quadruple-therapy group, 34% of the hybrid group, and 37% of the high-dose therapy groups. Clarithromycin resistance occurred in about 23% of quadruple therapy recipients, 16% of hybrid recipients, and 16% of high-dose therapy recipients. Amoxicillin and tetracycline resistance was rare, occurring in approximately 0%-3% of groups.
In the quadruple therapy arm, metronidazole resistance was associated with H. pylori eradication failure, according to Hsu. The eradication rate was about 96% for those subjects with no metronidazole resistance, and 88% for those with resistance (P = .05). Amoxicillin resistance, although rare in the study, independently predicted eradication failure of high-dose dual therapy, Hsu said. The eradication rate with high-dose dual therapy was 87.6% for individuals without amoxicillin resistance, and 40.0% in individuals with resistance, according to presented data.
The authors reported no financial disclosures related to their research. Buensalido has been a speaker for Unilab, BSV Bioscience, and Philcare Pharma, and has received sponsorship from Pfizer.
This article originally appeared on MDedge.com, part of the Medscape Professional Network.
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