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Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data

BACKGROUND: Helicobacter pylori (H. pylori) infects ~ 35% of Americans and can lead to serious sequelae if left untreated. Growing evidence indicates that clarithromycin-based therapies (CBT) are becoming increasingly ineffective for treating H. pylori infection. RHB-105 was approved by the US Food...

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Detalles Bibliográficos
Autores principales: Howden, Colin W., Sheldon, Kely L., Almenoff, June S., Chey, William D.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9352601/
https://www.ncbi.nlm.nih.gov/pubmed/34862940
http://dx.doi.org/10.1007/s10620-021-07323-5
Descripción
Sumario:BACKGROUND: Helicobacter pylori (H. pylori) infects ~ 35% of Americans and can lead to serious sequelae if left untreated. Growing evidence indicates that clarithromycin-based therapies (CBT) are becoming increasingly ineffective for treating H. pylori infection. RHB-105 was approved by the US Food and Drug Administration in 2019 for the treatment of H. pylori infection in adults. AIMS: The primary aim of this study was to assess prescribing patterns and associated cure rates of physician-directed therapy for subjects with persistent H. pylori infection after participation in one of two Phase 3 clinical trials (ERADICATE Hp and ERADICATE Hp2). METHODS: We reviewed study reports to identify specific physician-directed regimens selected for subjects whose H. pylori infection was not eradicated. We also conducted a CYP2C19 genotype analysis of subjects who were prescribed CBT. Finally, we analyzed real-world H. pylori retail prescription data and compared these with to the physician-directed therapies in the clinical trials studies. RESULTS: Following ERADICATE Hp, CBT was prescribed for 27/31 (87%) subjects achieving a 59.3% cure rate. Following ERADICATE Hp2, CBT was prescribed for 48/94 (51%) subjects achieving a 60.4% cure rate. Rapid CYP2C19 metabolizers (2/11) had a cure rate of 18.2% with CBT. Real-world prescription data from IQVIA showed more than 80% of prescriptions for H. pylori infection were for CBT. CONCLUSIONS: Rates of CBT use persist despite sub-optimal eradication rates. Since RHB-105 does not contain clarithromycin, it can be prescribed first-line without concerns about clarithromycin resistance or CYP2C19 status. NCT03198507 & NCT01980095.