Three-drug combination, RHB-105, effectively eradicates H pylori infection in adults

The three-drug combination of omeprazole, amoxicillin, and rifabutin in one capsule, RHB-105, effectively eradicates Helicobacter pylori infection in adults. The novel formulation was found to still be effective and well-tolerated in an environment of clinically significant antibiotic resistance. Findings from a double-blind randomized trial are published in Annals of Internal Medicine.

H. pylori infection is the main cause of gastrointestinal diseases, such as peptic ulcer, gastritis, and gastric cancer. Current guidelines recommend eradication of the infection, but it is difficult to treat because success with previously effective therapies has declined, related largely to the worldwide increase in antibiotic resistance. Both the World Health Organization and the US Food and Drug Administration (FDA) have designated clarithromycin-resistant H pylori as a focus for new drug development, and the FDA included it as a pathogen with "the potential to pose a serious threat to public health."

Researchers at 55 clinical research sites in the United States, led by researchers from the Michael E. De-Bakey Veterans Affairs Medical Center, randomly assigned 455 treatment-naive adults with epigastric discomfort and confirmed H pylori infection to triple therapy with RBH-105 or dual therapy of amoxicillin/omeprazole to assess the effectiveness of RHB-105 for H pylori eradication. The researchers found that H. pylori eradication rate was significantly greater following treatment with the rifabutin-based triple therapy than with high-dose amoxicillin/omeprazole dual therapy. Eradication rates were not affected by H. pylori resistance to clarithromycin or metronidazole, which suggests that RHB-105 should be considered as a first-line empirical therapy of H pylori infection.