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Real-life experience with fidaxomicin in Clostridioides difficile infection: a multicentre cohort study on 244 episodes

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Abstract

The high cost of fidaxomicin has restricted its use despite the benefit of a lower Clostridioides difficile infection (CDI) recurrence rate at 4 weeks of follow-up. This short follow-up represents the main limitation of pivotal clinical trials of fidaxomicin, and some recent studies question its benefits over vancomycin. Moreover, the main risk factors of recurrence after treatment with fidaxomicin remain unknown. We designed a multicentre retrospective cohort study among four Spanish hospitals to assess the efficacy of fidaxomicin in real life and to investigate risk factors of fidaxomicin failure at weeks 8 and 12. Two-hundred forty-four patients were included. Fidaxomicin was used in 96 patients (39.3%) for a first episode of CDI, in 95 patients (38.9%) for a second episode, and in 53 patients (21.7%) for a third or subsequent episode. Patients treated with fidaxomicin in a first episode were younger (59.9 years vs 73.5 years), but they had more severe episodes (52.1% vs. 32.4%). The recurrence rates for patients treated in the first episode were 6.5% and 9.7% at weeks 8 and 12, respectively. Recurrence rates increased for patients treated at second or ulterior episodes (16.3% and 26.4% at week 8, respectively). Age greater than or equal to 85 years and having had a previous episode of CDI were identified as recurrence risk factors at weeks 8 and 12. We conclude that the outcomes with fidaxomicin in real life are at least as good as those observed in clinical trials despite a more demanding evaluation. Be it 85 years of age or older, and the use after a first episode appears to be independent factors of CDI recurrence after treatment with fidaxomicin.

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Acknowledgements

We thank Alfonso Muriel for providing help with the statistical analysis.

Funding

No external funding was received. This study was conducted as part of our routine work.

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Authors and Affiliations

  1. Infectious Disease Department, University Hospital Ramon Y Cajal, Ctra. Colmenar Viejo, Km 9,1. Zip code 28034, Madrid, Spain

    Rosa Escudero-Sánchez & Javier Cobo

  2. Spanish Network for Research in Infectious Disease (REIPI), Madrid, Spain

    Rosa Escudero-Sánchez, Sergio García Fernández & Javier Cobo

  3. Internal Medicine Department, University Hospital Puerta de Hierro-Majadahonda, Madrid, Spain

    Angela Valencia-Alijo, Ángela Gutiérrez-Rojas & Antonio Ramos-Martínez

  4. Internal Medicine Department, University Hospital La Fe, Valencia, Spain

    Sandra Cuéllar Tovar, Miguel Salavert Lletí & Iván Castro Hernández

  5. Internal Medicine Department, University Hospital General de Alicante, Alicante, Spain

    Esperanza Merino-de Lucas & Livia Giner

  6. Microbiology Department, University Hospital Ramón Y Cajal, Madrid, Spain

    Sergio García Fernández

Authors
  1. Rosa Escudero-Sánchez
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  2. Angela Valencia-Alijo
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  3. Sandra Cuéllar Tovar
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  4. Esperanza Merino-de Lucas
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  6. Ángela Gutiérrez-Rojas
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  8. Miguel Salavert Lletí
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  11. Javier Cobo
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Corresponding author

Correspondence to Rosa Escudero-Sánchez.

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Conflicts of interests

JC has received consulting and speaking fees from Astellas Pharma and MSD; MS has participated in scientific consultancies and held professional conferences organized by MSD and Astellas Pharma in the past year; RE has received support from Astellas and MSD to attend conferences and congresses; EM has participated in scientific consultancies organized by MSD in the past year; AR has received support from Astellas in advisory and training tasks; no conflicts of interest were reported by other authors.

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Escudero-Sánchez, R., Valencia-Alijo, A., Cuéllar Tovar, S. et al. Real-life experience with fidaxomicin in Clostridioides difficile infection: a multicentre cohort study on 244 episodes. Infection 49, 475–482 (2021). https://doi.org/10.1007/s15010-020-01567-5

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  • DOI: https://doi.org/10.1007/s15010-020-01567-5

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