Fourth-line rescue therapy with rifabutin in patients with three Helicobacter pylori eradication failures

Authors

  • J. P. Gisbert,

    Corresponding author
    1. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
    • Gastroenterology Department, Hospital de La Princesa and Instituto de Investigación Sanitaria Princesa (IP), Madrid, Spain
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  • M. Castro-Fernandez,

    1. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
    2. Gastroenterology Department, Hospital de Valme, Sevilla, Spain
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  • A. Perez-Aisa,

    1. Gastroenterology Department, Agencia Sanitaria Costa del Sol, Málaga, Spain
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  • A. Cosme,

    1. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
    2. Gastroenterology Department, Hospital de Donostia, San Sebastián, Spain
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  • J. Molina-Infante,

    1. Gastroenterology Department, Hospital de San Pedro de Alcántara, Cáceres, Spain
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  • L. Rodrigo,

    1. Gastroenterology Department, Hospital Central de Asturias, Oviedo, Spain
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  • I. Modolell,

    1. Gastroenterology Department, Consorci Sanitari de Terassa, Barcelona, Spain
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  • J. L. Cabriada,

    1. Gastroenterology Department, Hospital de Galdakao, Vizcaya, Spain
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  • J. L. Gisbert,

    1. Gastroenterology Department, Hospital de La Princesa and Instituto de Investigación Sanitaria Princesa (IP), Madrid, Spain
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  • E. Lamas,

    1. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
    2. Gastroenterology Department, Hospital de Valme, Sevilla, Spain
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  • E. Marcos,

    1. Gastroenterology Department, Hospital de La Princesa and Instituto de Investigación Sanitaria Princesa (IP), Madrid, Spain
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  • X. Calvet,

    1. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Spain
    2. Gastroenterology Department, Hospital de Sabadell, Barcelona, Spain
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  • on behalf of the H. pylori Study Group of the Asociación Española de Gastroenterología (Spanish Gastroenterology Association)


Correspondence to:

Prof. J. P. Gisbert, Playa de Mojácar 29, Urb. Bonanza, 28669 Boadilla del Monte, Madrid, Spain.

E-mail: gisbert@meditex.es

Summary

Background

In some cases, Helicobacter pylori infection persists even after three eradication treatments.

Aim

To evaluate the efficacy of an empirical fourth-line rescue regimen with rifabutin in patients with three eradication failures.

Methods

Design: Multicentre, prospective study. Patients: In whom the following three treatments had consecutively failed: first (PPI + clarithromycin + amoxicillin); second (PPI + bismuth + tetracycline + metronidazole); third (PPI + amoxicillin + levofloxacin). Intervention: A fourth regimen with rifabutin (150 mg b.d.), amoxicillin (1 g b.d.) and a PPI (standard dose b.d.) was prescribed for 10 days. Outcome: Eradication was confirmed by 13C-urea breath test 4–8 weeks after therapy. Compliance and tolerance: Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated using a questionnaire.

Results

One-hundred patients (mean age 50 years, 39% men, 31% peptic ulcer/69% functional dyspepsia) were included. Eight patients did not take the medication correctly (in six cases due to adverse effects). Per-protocol and intention-to-treat eradication rates were 52% (95% CI = 41–63%) and 50% (40–60%). Adverse effects were reported in 30 (30%) patients: nausea/vomiting (13 patients), asthenia/anorexia (8), abdominal pain (7), diarrhoea (5), fever (4), metallic taste (4), myalgia (4), hypertransaminasemia (2), leucopenia (<1,500 neutrophils) (2), thrombopenia (<150 000 platelets) (2), headache (1) and aphthous stomatitis (1). Myelotoxicity resolved spontaneously in all cases.

Conclusions

Even after three previous H. pylori eradication failures, an empirical fourth-line rescue treatment with rifabutin may be effective in approximately 50% of the cases. Therefore, rifabutin-based rescue therapy constitutes a valid strategy after multiple previous eradication failures with key antibiotics, such as clarithromycin, metronidazole, tetracycline and levofloxacin.

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