What is the recommended treatment for Helicobacter pylori (H. pylori) infection in a patient with an allergy to Azithromycin (azithromycin)?

From the Guidelines

For patients allergic to azithromycin who require H. pylori treatment, a bismuth quadruple therapy is recommended. This regimen consists of a proton pump inhibitor (such as omeprazole 20 mg twice daily), bismuth subsalicylate (525 mg four times daily), metronidazole (500 mg three times daily), and tetracycline (500 mg four times daily) for 14 days, as suggested by the Toronto Consensus, Maastricht V/Florence, and American College of Gastroenterology recommendations 1.

Key Considerations

• The bismuth quadruple therapy is preferred due to its effectiveness and the increasing resistance to clarithromycin and levofloxacin in many regions 1.
• In patients with true penicillin allergy, the ACG and Maastricht V/Florence both recommend either clarithromycin-based triple therapy with metronidazole or bismuth quadruple therapy, but the Toronto Consensus prefers the latter based upon superiority over the clarithromycin/metronidazole triple therapy in a prospective study 1.
• Treatment selection should consider local antibiotic resistance patterns, and eradication should be confirmed with a urea breath test, stool antigen test, or endoscopic biopsy at least 4 weeks after completing therapy and after discontinuing proton pump inhibitors for at least 2 weeks to avoid false negative results.

Alternative Options

• If the patient is not allergic to other macrolides, clarithromycin can be substituted for azithromycin in triple therapy regimens, but this is not the preferred option due to increasing resistance 1.
• Another option is levofloxacin-based triple therapy, which includes a proton pump inhibitor, amoxicillin (1 g twice daily), and levofloxacin (500 mg once daily) for 10-14 days, but this should be considered based on local resistance patterns and patient-specific factors 1.
• For patients with penicillin allergy, metronidazole can replace amoxicillin in levofloxacin-based triple therapy 1.

From the FDA Drug Label

Adult Patients only Helicobacter pylori Infection and Duodenal Ulcer Disease: Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole : Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Dual therapy for H. pylori with lansoprazole : Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected.

The recommended treatment for Helicobacter pylori (H. pylori) infection in a patient with an allergy to Azithromycin is amoxicillin in combination with lansoprazole as dual therapy, as the patient is allergic to a different antibiotic (azithromycin), but the label suggests dual therapy with lansoprazole for those allergic or intolerant to clarithromycin 2.

From the Research

Treatment Options for H. pylori Infection in Patients Allergic to Azithromycin

• The recommended treatment for H. pylori infection in patients allergic to azithromycin is not directly stated in the provided studies, as they focus on penicillin allergy rather than azithromycin allergy.
• However, based on the studies, the following treatment options can be considered:
  • A combination of omeprazole, clarithromycin, and metronidazole for 7-14 days 3, 4, 5.
  • A quadruple therapy with a proton-pump inhibitor (PPI), bismuth, tetracycline, and metronidazole 4, 6.
  • A levofloxacin-based regimen with a PPI and clarithromycin for 10 days 4, 5, 6.
• The efficacy of these treatment options varies, with the quadruple therapy showing higher eradication rates (91%) compared to the triple combination with clarithromycin and metronidazole (64-69%) 4, 6.
• The choice of treatment should be based on the patient's specific situation and medical history, as well as the availability of antibiotics and the potential for antibiotic resistance.

Efficacy of Treatment Options

• The efficacy of the treatment options is as follows:
  • Omeprazole, clarithromycin, and metronidazole: 64-69% eradication rate 4, 5.
  • Quadruple therapy with PPI, bismuth, tetracycline, and metronidazole: 91% eradication rate 6.
  • Levofloxacin-based regimen with PPI and clarithromycin: 71-73% eradication rate 5, 6.
• These efficacy rates are based on studies that included patients allergic to penicillin, and may not be directly applicable to patients allergic to azithromycin.

Safety and Tolerability

• The safety and tolerability of the treatment options are generally good, with mild side effects reported in some patients 3, 4, 5.
• However, the rifabutin-based regimen was found to be ineffective and poorly tolerated, with adverse effects reported in 89% of patients 4.