Helicobacter pylori (H. pylori) Infection
H. pylori is a bacterial pathogen that infects approximately 35% of the U.S. population and 45% of the population in the five major countries in Europe (France, Germany, Italy, Spain, and the United Kingdom). As a result of the chronic inflammation induced by H. pylori infection, approximately 20% of infected patients develop a range of pathologies including dyspepsia, peptic ulcer disease, gastric cancer, and mucosa-associated lymphoid tissue (MALT) lymphoma.
Gastric cancer is the third most common cause of cancer-related death worldwide, and over 80% of gastric cancers are attributed to H. pylori infection.
Treatment of H. pylori infection has been proven to reduce the incidence of gastric cancer, and the American College of Gastroenterologists (ACG) guidelines recommend treatment for all patients diagnosed with H. pylori infection, typically using PPIs in conjunction with antibiotics. Anti-secretory agents reduce gastric acid level, thereby increasing antibiotic stability and potency against H. pylori.
H. pylori eradication rates have fallen from >90% in the 1990s to current rates of <80% due to increasing antibiotic resistance. In 2017, the World Health Organization (WHO) listed H. pylori among the 16 antibiotic-resistant bacteria that pose the greatest threat to human health and designated H. pylori as a Class 1 carcinogen, meaning that it is a definite known cause of cancer. In 2014, the FDA added H. pylori to the agency’s list of qualifying pathogens that have the potential to pose a serious threat to public health under the Generating Antibiotic Incentives Now (GAIN) Act.