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Pitfalls of Physician-Directed Treatment of Helicobacter pylori: Results from Two Phase 3 Clinical Trials and
Colin W Howden1, Kely L Sheldon2, June S Almenoff3
1University of Tennessee College of Medicine, Memphis, TN, USA.
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.
Insights
Clarithromycin-based therapies (CBT) for H. pylori infection show declining cure rates, even in rapid CYP2C19 metabolizers. Prescribing patterns indicate continued reliance on CBT despite its ineffectiveness, highlighting a need for alternative treatments like RHB-105.
Area of Science:
- Gastroenterology
- Infectious Diseases
- Pharmacology
Background:
- Helicobacter pylori (H. pylori) infection affects approximately 35% of Americans, potentially leading to severe complications if untreated.
- Emerging data reveal a concerning decrease in the efficacy of clarithromycin-based therapies (CBT) for H. pylori eradication.
- RHB-105 received FDA approval in 2019 for treating H. pylori infection in adults.
Purpose of the Study:
- To evaluate the prescribing trends and success rates of physician-administered treatments for H. pylori infections that persisted after clinical trials.
- To analyze the impact of CYP2C19 genotype on the effectiveness of CBT.
- To compare real-world H. pylori prescription data with clinical trial treatment regimens.
Main Methods:
- Review of study reports to identify physician-directed regimens for patients with persistent H. pylori infection.
- CYP2C19 genotype analysis for subjects treated with CBT.
- Analysis of real-world H. pylori retail prescription data (IQVIA) and comparison with clinical trial data.
Main Results:
- Following the ERADICATE Hp trial, 87% of persistent H. pylori cases were treated with CBT, achieving a 59.3% cure rate.
- In the ERADICATE Hp2 trial, 51% of persistent H. pylori cases received CBT, with a 60.4% cure rate.
- Rapid CYP2C19 metabolizers exhibited a low 18.2% cure rate with CBT, and real-world data showed over 80% of H. pylori prescriptions were for CBT.
Conclusions:
- Clarithromycin-based therapy (CBT) use continues despite suboptimal eradication rates.
- RHB-105 offers a clarithromycin-free alternative, suitable for first-line use without concerns regarding clarithromycin resistance or CYP2C19 metabolism.
- Clinical trial identifiers: NCT03198507 & NCT01980095.
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