What is the management of Helicobacter pylori (H. pylori) infection in patients with a penicillin allergy?

From the Guidelines

For patients with H. pylori infection and penicillin allergy, the recommended treatment is a bismuth quadruple therapy consisting of a proton pump inhibitor, bismuth subsalicylate, tetracycline, and metronidazole for 14 days, as it is the preferred first-line therapy according to the most recent guidelines 1. The bismuth quadruple therapy is preferred due to its high eradication rates and ability to prevent antibiotic resistance. The regimen typically includes a proton pump inhibitor (such as omeprazole 20mg twice daily), bismuth subsalicylate (525mg four times daily), tetracycline (500mg four times daily), and metronidazole (500mg three times daily) for 14 days.

• The bismuth component in the quadruple therapy helps prevent antibiotic resistance by disrupting the bacterial cell membrane.
• The use of a proton pump inhibitor, such as omeprazole, helps to reduce stomach acid and create a more favorable environment for the antibiotics to work.
• The Toronto Consensus prefers the bismuth quadruple therapy over clarithromycin-based triple therapy due to its superiority in a prospective study 1. Alternatively, a levofloxacin-based triple therapy can be used, which includes a proton pump inhibitor, levofloxacin, and clarithromycin for 14 days, but this is generally recommended as a second-line alternative in areas of low fluoroquinolone resistance 2. It's essential to confirm the eradication of H. pylori at least 4 weeks after completing therapy, using either a urea breath test, stool antigen test, or endoscopic biopsy.
• If the patient has a history of severe allergic reaction to penicillin, skin testing may be considered before treatment to confirm the allergy, as many patients who report penicillin allergy are not truly allergic.
• In cases where the first-line treatment fails, a rescue regimen such as a levofloxacin-containing regimen or rifabutin may be considered, and susceptibility testing may be necessary to guide the choice of antibiotics 2.

From the FDA Drug Label

Adult Patients only Helicobacter pylori Infection and Duodenal Ulcer Disease: Triple therapy for Helicobacter pylori (H. pyli) 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. pyli. Eradication of H. pyli has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pyli with lansoprazole : Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H pyli 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 management of Helicobacter pyli (H. pyli) infection in patients with a penicillin allergy is not directly addressed in the provided drug labels. However, for patients who are allergic or intolerant to clarithromycin, dual therapy with amoxicillin and lansoprazole can be considered for the treatment of H. pyli infection and duodenal ulcer disease 3.

• Key considerations: + Penicillin allergy: The provided drug labels do not provide guidance on alternative therapies for patients with a penicillin allergy. + H. pyli treatment: Dual therapy with amoxicillin and lansoprazole is an option for patients who are allergic or intolerant to clarithromycin. + Clinical decision: A conservative clinical decision would be to consult the prescribing information for alternative antibiotics or seek guidance from a specialist for patients with a penicillin allergy.

From the Research

Management of H. pylori Infection in Patients with Penicillin Allergy

The management of Helicobacter pylori (H. pylori) infection in patients with a penicillin allergy can be challenging due to the limited treatment options.

• First-line treatment options include: + A combination of a proton pump inhibitor (PPI), clarithromycin, and metronidazole for 7-10 days 4, 5 + Bismuth-based quadruple therapy for 10-14 days, which appears to be the most effective option 6, 5 + Tetracycline and metronidazole based quadruple regimen for 14 days, which has been shown to have a relatively high eradication rate 7
• Second-line treatment options include: + Levofloxacin-based triple therapy for 10 days, which has been shown to be effective in patients who have failed first-line treatment 6, 5 + Bismuth quadruple therapy, which can be used as a rescue treatment 5
• Third- and fourth-line treatment options are limited, but may include the use of rifabutin-based regimens, although these have been shown to be poorly tolerated and ineffective 4, 5

Treatment Regimens and Eradication Rates

The eradication rates for different treatment regimens vary, with:

• First-line treatment with PPI, clarithromycin, and metronidazole: 57-64% 4, 5
• First-line treatment with bismuth-based quadruple therapy: 74-75% 5
• Second-line treatment with levofloxacin-based triple therapy: 64% 5
• Third- and fourth-line treatment with rifabutin-based regimens: 22% 5

Adverse Effects and Compliance

Adverse effects and compliance with treatment regimens also vary, with:

• First-line treatment with PPI, clarithromycin, and metronidazole: mild adverse effects in 14% of patients, compliance 94% 5
• First-line treatment with bismuth-based quadruple therapy: mild adverse effects in 14% of patients, compliance 98% 5
• Second-line treatment with levofloxacin-based triple therapy: adverse effects in 23-29% of patients, compliance 88-100% 5
• Third- and fourth-line treatment with rifabutin-based regimens: poorly tolerated, with adverse effects in 89% of patients 4