Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Correspondence
  • Published:

Reply to ‘The ethics of unlicensed therapy use in primary biliary cholangitis: a counter view’

Nature Reviews Gastroenterology & Hepatology (2026)Cite this article

Subjects

We thank our esteemed colleagues Jones and co-authors for their thoughtful counterpoint in response to our Comment (Bezafibrate for primary biliary cholangitis: time to act on the evidence. Nat. Rev. Gastroenterol. Hepatol. 22, 805–807 (2025))1 on the off-label use of bezafibrate as second-line therapy for primary biliary cholangitis (PBC) (Jones, D. E. J. et al. The ethics of unlicensed therapy use in primary biliary cholangitis: a counter view. Nat. Rev. Gastroenterol. Hepatol. https://doi.org/10.1038/s41575-026-01179-8 (2026))2. We welcome this reaction and the ensuing discussion, which we believe is both timely and essential, benefiting all stakeholders involved in PBC care (including patients, clinicians, health authorities and industry) and, ultimately, enabling readers to form their own informed views.

First, we wish to reaffirm our strong support for the development of innovative therapies for PBC. In this regard, we, like Jones and co-authors, have all actively contributed to the development of approved treatments for this disease. That said, it is a matter of record that, compared with other peroxisome proliferator-activated receptor (PPAR) agonists evaluated in PBC, bezafibrate has demonstrated evidence of efficacy across multiple clinically relevant endpoints, including serum alkaline phosphatase and bilirubin levels, pruritus, liver stiffness, the Enhanced Liver Fibrosis score, histological fibrosis stage and transplant-free survival.

This is a preview of subscription content, access via your institution

Access options

Buy this article

  • Purchase on SpringerLink
  • Instant access to the full article PDF.

USD 39.95

Prices may be subject to local taxes which are calculated during checkout

References

  1. Corpechot, C. et al. Bezafibrate for primary biliary cholangitis: time to act on the evidence. Nat. Rev. Gastroenterol. Hepatol. 22, 805–807 (2025).

    Article  PubMed  Google Scholar 

  2. Jones, D. E. J. et al. The ethics of unlicensed therapy use in primary biliary cholangitis: a counter view. Nat. Rev. Gastroenterol. Hepatol. https://doi.org/10.1038/s41575-026-01179-8 (2026).

    Article  Google Scholar 

  3. Tanaka, A. et al. Association of bezafibrate with transplant-free survival in patients with primary biliary cholangitis. J. Hepatol. 75, 565–571 (2021).

    Article  PubMed  Google Scholar 

  4. van Hooff, M. C. et al. Effectiveness and tolerability of bezafibrate in primary biliary cholangitis: a nationwide real-world study. Am. J. Gastroenterol. https://doi.org/10.14309/ajg.0000000000003879 (2025).

    Article  PubMed  Google Scholar 

  5. Prince, M., Chetwynd, A., Newman, W., Metcalf, J. V. & James, O. F. W. Survival and symptom progression in a geographically based cohort of patients with primary biliary cirrhosis: follow-up for up to 28 years. Gastroenterology 123, 1044–1051 (2002).

    Article  PubMed  Google Scholar 

  6. Corpechot, C. & Poupon, R. Geotherapeutics of primary biliary cirrhosis: bright and sunny around the Mediterranean but still cloudy and foggy in the United Kingdom. Hepatology 46, 963–965 (2007).

    Article  PubMed  Google Scholar 

  7. Rigamonti, C. et al. Primary biliary cirrhosis (PBC) with baseline normal bilirubin and albumin concentrations: treatment with ursodeoxycholic acid (UDCA) improves liver-related and non liverrelated survival. Hepatology 52, 487A (2010).

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Reference Center for Inflammatory Biliary Diseases and Autoimmune Hepatitis, European Reference Network on Hepatological Diseases (ERN Rare-Liver), INSERM UMR_S938, Saint-Antoine Hospital, Assistance Publique - Hôpitaux de Paris, Sorbonne University, Paris, France

    Christophe Corpechot

  2. Liver Unit, Hospital Clínic Barcelona, Fundació de Recerca Clínic Barcelona-Institut d’Investigacions Biomèdiques August Pi i Sunyer (FRCB-IDIBAPS), European Reference Network on Hepatological Diseases (ERN Rare-Liver), Universitat de Barcelona, Barcelona, Spain

    Maria-Carlota Londoño

  3. Liver Autoimmunity Unit, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina

    Alejandra Villamil

  4. Department of Gastroenterology and Hepatology, Hvidovre University Hospital, European Reference Network on Hepatological Diseases (ERN Rare-Liver), Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

    Henriette Ytting

  5. Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan

    Atsushi Tanaka

  6. Department of Gastroenterology and Hepatology, Tytgat Institute for Liver and Intestinal Research, AGEM, Amsterdam University Medical Center, Amsterdam, the Netherlands

    Ulrich Beuers

Authors
  1. Christophe Corpechot
    View author publications

    Search author on:PubMed Google Scholar

  2. Maria-Carlota Londoño
    View author publications

    Search author on:PubMed Google Scholar

  3. Alejandra Villamil
    View author publications

    Search author on:PubMed Google Scholar

  4. Henriette Ytting
    View author publications

    Search author on:PubMed Google Scholar

  5. Atsushi Tanaka
    View author publications

    Search author on:PubMed Google Scholar

  6. Ulrich Beuers
    View author publications

    Search author on:PubMed Google Scholar

Corresponding author

Correspondence to Christophe Corpechot.

Ethics declarations

Competing interests

C.C. reports grants from Intercept Pharmaceuticals and Arrow Génériques, and consulting work for Cymabay, Gilead, Ipsen, Calliditas, GSK, Mirum, Advanz, Echosens and Intercept Pharmaceuticals. M.-C.L. reports grants from Gilead and Mirum, consulting work for Advanz, Mirum, Gilead, Ipsen, Falk and GSK, and lectures for Advanz, GSK, Gilead and Ipsen. H.Y. reports participation in advisory board for Ipsen and congress participation by invitation from Ipsen. A.V. reports speaker fees from Intercept. A.T. reports consultant work for GSK, Kowa, Kaken Pharmaceuticals, Ipsen, Mirum, Abbvie and Gilead. U.B. reports consulting and/or lecture fees from Abacus, Amgen, Behring, GSK, Ipsen, Mirum, Ono.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Corpechot, C., Londoño, MC., Villamil, A. et al. Reply to ‘The ethics of unlicensed therapy use in primary biliary cholangitis: a counter view’. Nat Rev Gastroenterol Hepatol (2026). https://doi.org/10.1038/s41575-026-01177-w

Download citation

  • Published:

  • Version of record:

  • DOI: https://doi.org/10.1038/s41575-026-01177-w

Search

Advanced search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing