We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Rifabutin-Based Triple Therapy (RHB-105) for Eradication: A Double-Blind, Randomized, Controlled Trial.
- Authors
Graham, David Y.; Canaan, Yamil; Maher, James; Wiener, Gregory; Hulten, Kristina G.; Kalfus, Ira N.
- Abstract
<bold>Background: </bold>Although consensus supports eradication of Helicobacter pylori infections, antimicrobial resistance has substantially reduced eradication rates with most current therapies.<bold>Objective: </bold>To assess the effectiveness of a novel rifabutin-based therapy (RHB-105) for H pylori eradication.<bold>Design: </bold>Phase 3, double-blind trial (ERADICATE Hp2). (ClinicalTrials.gov: NCT03198507).<bold>Setting: </bold>55 clinical research sites in the United States.<bold>Participants: </bold>455 treatment-naive adults with epigastric discomfort and confirmed H pylori infection.<bold>Intervention: </bold>RHB-105 (amoxicillin, 3 g; omeprazole, 120 mg; and rifabutin, 150 mg) versus active comparator (amoxicillin, 3 g, and omeprazole, 120 mg), given as 4 capsules every 8 hours for 14 days.<bold>Measurements: </bold>Between-group difference for H pylori eradication rate, demonstrated by 13C urea breath test 4 weeks after treatment, analyzed by using the χ2 test.<bold>Results: </bold>In the intention-to-treat population, the eradication rate was higher with RHB-105 than with the active comparator (228 vs. 227 patients, respectively; 83.8% [95% CI, 78.4% to 88.0%] vs. 57.7% [95% CI, 51.2% to 64.0%]; P < 0.001). Eradication rates were unaffected by resistance to clarithromycin or metronidazole. No rifabutin resistance was detected. The most commonly reported adverse events (incidence ≥5%) were diarrhea (10.1% with RHB-105 vs. 7.9% with active comparator), headache (7.5% vs. 7.0%), and nausea (4.8% vs. 5.3%).<bold>Limitation: </bold>Persons of Asian descent were excluded because of their higher prevalence of poor cytochrome P450 2C19 metabolizers.<bold>Conclusion: </bold>These findings suggest potential for RHB-105 as first-line empirical H pylori therapy, addressing an unmet need in the current environment of increasing antibiotic resistance.<bold>Primary Funding Source: </bold>RedHill Biopharma Ltd.
- Subjects
UNITED States; HELICOBACTER pylori infections; HELICOBACTER pylori; DRUG resistance in microorganisms; DRUG resistance in bacteria; CYTOCHROME P-450; ANTIBIOTICS; COMBINATION drug therapy; ANTI-infective agents; PROTON pump inhibitors; RANDOMIZED controlled trials; OMEPRAZOLE; BLIND experiment; STATISTICAL sampling; AMOXICILLIN; HELICOBACTER diseases
- Publication
Annals of Internal Medicine, 2020, Vol 172, Issue 12, p795
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/M19-3734