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Open AccessArticle

Rifabutin-Containing Triple Therapy (RHB-105) for Eradication of Helicobacter pylori: Randomized ERADICATE Hp Trial

1
Independent Consultant, M2g Consulting, 251 Central Park West, New York, NY 10024, USA
2
Department of Medicine, Michael E. DeBakey VA Medical Center and Baylor College of Medicine, 2002 Holcombe Boulevard, Houston, TX 77030, USA
3
Anaheim Clinical Trials, 1085 N. Harbor Blvd, Anaheim, CA 92801, USA
4
Medical Affairs, RedHill Biopharma, Inc., 8045 Arco Corporate Drive, Suite 200, Raleigh, NC 27617, USA
*
Author to whom correspondence should be addressed.
Received: 10 September 2020 / Revised: 2 October 2020 / Accepted: 5 October 2020 / Published: 9 October 2020
(This article belongs to the Special Issue Efficacy of Combinations of Different Antibiotics)
Due to increasing resistance to commonly used antibiotics, the World Health Organization and Food and Drug Administration have advocated the development of new therapeutic regimens for Helicobacter pylori (H. pylori). This phase three, double-blind study (ERADICATE Hp) randomized (2:1) treatment-naïve adults with H. pylori infection and dyspepsia to RHB-105 (an all-in-one combination of omeprazole 40 mg, amoxicillin 1000 mg, and rifabutin 50 mg) or an identically-appearing placebo, both administered every 8 h for 14 days. The H. pylori eradication rate with RHB-105, using a modified intent-to-treat (mITT) population of subjects who received ≥1 dose of study drug and had test-of-eradication performed 28–35 days post-completion of therapy, was compared (one-sample Z-test) to a literature-derived comparator rate of 70% and success rate with physician-selected standard-of-care given to placebo failures. The mITT H. pylori eradication rate (95% CI) with RHB-105 of 89.4% (82.0–96.8%) was greater than both the literature-derived comparator rate (P < 0.001) and the standard-of-care rate of 63.0% (44.8–81.1%) (P = 0.006). Adverse events with an incidence ≥5% for RHB-105 were diarrhea (12.7%), headache (11.9%), chromaturia (9.3%), abdominal tenderness (6.8%), and dizziness (5.1%). No leukopenia was noted. RHB-105 (Talicia®) proved to be a safe and effective empiric therapy for H. pylori eradication. View Full-Text
Keywords: RHB-105; rifabutin; Helicobacter pylori; standard-of-care; dyspepsia; clinical trial RHB-105; rifabutin; Helicobacter pylori; standard-of-care; dyspepsia; clinical trial
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MDPI and ACS Style

Kalfus, I.N.; Graham, D.Y.; Riff, D.S.; Panas, R.M. Rifabutin-Containing Triple Therapy (RHB-105) for Eradication of Helicobacter pylori: Randomized ERADICATE Hp Trial. Antibiotics 2020, 9, 685. https://0-doi-org.brum.beds.ac.uk/10.3390/antibiotics9100685

AMA Style

Kalfus IN, Graham DY, Riff DS, Panas RM. Rifabutin-Containing Triple Therapy (RHB-105) for Eradication of Helicobacter pylori: Randomized ERADICATE Hp Trial. Antibiotics. 2020; 9(10):685. https://0-doi-org.brum.beds.ac.uk/10.3390/antibiotics9100685

Chicago/Turabian Style

Kalfus, Ira N.; Graham, David Y.; Riff, Dennis S.; Panas, Raymond M. 2020. "Rifabutin-Containing Triple Therapy (RHB-105) for Eradication of Helicobacter pylori: Randomized ERADICATE Hp Trial" Antibiotics 9, no. 10: 685. https://0-doi-org.brum.beds.ac.uk/10.3390/antibiotics9100685

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