Article Text

Primary biliary cholangitis and SARS-CoV-2 infection: incidence, susceptibility and outcomes
  1. Javier Ampuero1,2,3,4,
  2. Ana Lucena1,
  3. Manuel Hernández-Guerra5,
  4. Isabel Moreno-Moraleda6,
  5. Juan Arenas7,
  6. Isabel Conde8,
  7. Laura Muñoz9,
  8. Lidia Canillas10,
  9. Edgar Fernandez11,
  10. Raisa Quiñones12,
  11. Miguel Angel Simon13,
  12. Elena Gómez-Dominguez14,
  13. Maria Luisa Gutierrez15,
  14. Conrado Fernandez-Rodriguez15,
  15. Maria Jose Domper-Arnal13,
  16. Francisco Jorquera4,12,
  17. Maria Luisa Garcia-Buey11,
  18. Montserrat Garcia-Retortillo10,
  19. Rosa Morillas4,9,
  20. Marina Berenguer4,8,
  21. Marta Casado6,
  22. Dalia Morales-Arraez5,
  23. José Manuel Sousa1,
  24. Esther Molina16
  1. 1 Hepatology Unit, Virgen del Rocio University Hospital, Sevilla, Spain
  2. 2 Instituto de Biomedicina de Sevilla, Sevilla, Spain
  3. 3 Facultad de Medicina, Universidad de Sevilla, Sevilla, Spain
  4. 4 (CIBERehd) Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas, Madrid, Spain
  5. 5 Gastroenterology and Hepatology, Hospital Universitario de Canarias, La Laguna, Spain
  6. 6 Digestive Department, Complejo Hospitalario Torrecardenas, Almeria, Spain
  7. 7 Digestive Department, Donostia Ospitalea, San Sebastian, Spain
  8. 8 Liver Transplantation and Hepatology Unit, Hospital Universitari i Politècnic La Fe de Valencia, Valencia, Spain
  9. 9 Digestive Department, Hospital Germans Trias i Pujol, Badalona, Spain
  10. 10 Digestive Department, Hospital del Mar, Barcelona, Spain
  11. 11 Digestive Department, Hospital Universitario de la Princesa, Madrid, Spain
  12. 12 Gastroenterology, IBIOMED, Complejo Asistencial Universitario de Leon, Leon, Spain
  13. 13 Digestive Department, Hospital Clinico Zaragoza, Zaragoza, Spain
  14. 14 Servicio de Aparato Digestivo, Hospital Universitario 12 de Octubre, Madrid, Spain
  15. 15 Digestive Diseases Unit, Alcorcón University Hospital, Alcorcon, Spain
  16. 16 Digestive Department, Hospital Clinico Universitario Santiago Compostela, Santiago de Compostela, Spain
  1. Correspondence to Dr Javier Ampuero, Virgen del Rocio University Hospital, Sevilla, Andalucía, Spain; javi.ampuero{at}

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We read with interest the work by Mansoor et al 1 regarding the outcomes of COVID-19 in coeliac disease. The impact of pre-existing chronic liver diseases on COVID-19 outcomes has been largely evaluated,2–4 and consequently specific recommendations have been made in these patients.5 However, the relationship between primary biliary cholangitis (PBC) and SARS-CoV-2 remains unknown.6 We aimed to determine (1) the cumulative incidence of SARS-CoV-2 infection in a population of patients with PBC, comparing with the general Spanish cumulative incidence by the end of April 2021; (2) the baseline factors associated with a higher susceptibility to SARS-CoV-2 infection; and (3) the baseline factors associated with COVID-19-related hospitalisation.

We performed a multicentre retrospective study enrolling 1151 patients from 13 Spanish referral hospitals. We collected information about SARS-CoV-2 infection from medical records of all patients with PBC from January 2020 to April 2021 (online supplemental material 1). Exclusion criteria were patients who died before January 2020, liver transplant before or after the enrolment and patients having received some dose of a vaccine against SARS-CoV-2.

Supplemental material

The Spanish government officially publishes the prevalence, incidence and outcomes of SARS-CoV-2 ( For this study, data were accessed on 30 April 2021. The cumulative incidence of SARS-CoV-2 infection was 7.3% (85 of 1151) in the PBC population vs 7% in the Spanish global population (p=0.567). In turn, the cumulative hospitalisation rate related to COVID-19 was 0.51% (238 891 of 47 026 208) in the Spanish population vs 1.74% (20 of 1151) (p=0.0001) in the PBC population. In addition, the cumulative mortality rate related to COVID-19 in Spain was 0.10% (48 436 of 47 026 208), while this rate was 0.35% (4 of 1151) in the PBC population (p=0.01). Table 1 summarises the age-specific cumulative incidence and hospitalisation comparing the overall and PBC populations.

Table 1

Comparison between the general Spanish population and the PBC cohort: age-specific cumulative incidence of SARS-CoV-2 infection and hospitalisation related to COVID-19

The baseline features of the overall cohort are presented in table 2. Albumin levels were decreased in patients with SARS-CoV-2 infection (4.14±0.45 g/dL vs 4.25±0.44 g/dL; p=0.033). Also, both positive anti-mitochondrial autoantibodies (AMA) (6.6% (59 of 898) vs negative 12.6% (22 of 174); p=0.006) and anti-Sp100 (4.1% (7 of 171) vs negative 8.4% (52 of 619); p=0.05) were inversely associated with infection. A higher protection was observed in patients with two positive autoantibodies (1.5%, 2 of 130) compared with those with only one (8%, 45 of 565) or subjects with none (12.6%, 12 of 95) (p=0.005). In the multivariate analysis (logistic regression), albumin levels (OR 0.41 (95% CI 0.23 to 0.75); p=0.003) and positive AMA (OR 0.41 (95% CI 0.22 to 0.77); p=0.006) were independently associated with SARS-CoV-2 infection (table 2). In the case of patients with positive AMA and anti-Sp100, the OR was 0.12 (95% CI 0.03 to 0.57; p=0.007).

Table 2

Baseline characteristics of the overall population and predictive factors associated with SARS-CoV-2 infection susceptibility in the overall PBC cohort

The proportion of patients who required hospital admission after SARS-CoV-2 infection was 23.5% (20 of 85), while 3.5% (3 of 85) required intensive care unit admission and 4.7% (4 of 85) died. Male sex, arterial hypertension, older age, and creatinine, alkaline phosphatase (ALP), albumin and platelet levels were associated with COVID-19-related hospitalisation in the univariate analysis. In the multivariate analysis (logistic regression), male sex (OR 13.44 (95% CI 1.92 to 94.13); p=0.009), arterial hypertension (OR 5.24 (95% CI 1.12 to 24.32); p=0.035), ALP levels (OR 1.004 (95% CI 1.00 to 1.01); p=0.05) and older age (OR 1.06 (95% CI 0.99 to 1.12); p=0.07) were independently associated with COVID-19-related hospitalisation in SARS-CoV-2-infected patients with PBC.

This nationwide study is the first to characterise the incidence and outcomes of SARS-CoV-2 in patients with PBC. First, we observed that both cumulative incidences of hospitalisation and mortality were greater in patients with PBC than in the general Spanish population, although the lack of adjustment for other comorbidities could be a limitation. Second, we found some factors associated with lower rates of SARS-CoV-2 infection, notably higher albumin levels and positive AMA antibodies. Third, ALP levels were independently associated with severe SARS-CoV-2 infection and requirement for hospital admission, beyond other known variables such as older age, male sex and arterial hypertension. Our study showed novel and relevant findings that could result in additional therapeutic decisions and preventive strategies in patients with PBC.

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Supplementary materials

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  • Contributors Guarantor of the article: JAm. Study design: JAm. Drafting the manuscript: JAm, CF-R, MB. Statistical analyses and interpretation: JAm. Data acquisition and critical review of the manuscript: all authors. All authors approved the final version of the article, including the authorship list.

  • Funding This project has been partially funded by the 'Consejería de Salud de la Junta de Andalucía' (PI-0075-2014) and the 'Spanish Ministry of Economy, Innovation and Competition, Instituto de Salud Carlos III' (PI19/01404, PI16/01842, PI17/00535 and GLD19/00100).

  • Disclaimer The funders have not had any role in the design, analysis, writing or interpretation of this project.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.