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Evaluation Video

Oral Presentation

Session: COVID-19: Part V

Ursodeoxycholic acid and severe COVID-19 outcomes in people with liver disease: a cohort study using the OpenSAFELY platform

Tuesday, August 27, 2024
1:30 PM – 1:45 PM CEST
Location: Conv Hall I C
Background: There is biological evidence that ursodeoxycholic acid (UDCA) - a common treatment of cholestatic liver diseases - may prevent severe COVID-19 outcomes. However, observational studies to date have obtained inconsistent results.

Objectives: To estimate the hazard of COVID-19 hospitalisation or death between 1 March 2020 and 31 December 2022, comparing UDCA treatment versus no UDCA treatment in a population with primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC).

Methods: With the approval of NHS England, we pre-registered and conducted a population-based cohort study using English primary care records, linked to death registration and hospital admissions data through the OpenSAFELY-TPP platform. We included adults with PBC or PSC diagnosed ≥6 months prior to 1st March 2020 (index date), registered with their practice for ≥6 months, and no prior liver transplant. We identified all UDCA prescriptions to determine time-varying UDCA exposure. The primary outcome was a composite of COVID-19 related death or hospitalisation. Cox proportional hazards regression was used to estimate hazard ratios (HR) and 95% confidence intervals (CI) for the association between time-varying UDCA exposure and COVID-19 related death or hospitalisation, stratified by geographical region and adjusted for pre-specified confounders. Sensitivity analyses varied the assumed duration of prescriptions and study population diagnosis. Secondary analyses limited the study period to start when a large majority of adults were vaccinated (1st March 2021). We derived cumulative incidence plots using Royston-Parmer models, standardised to the covariate distribution in the exposed groups.

Results: We identified 11,305 people who met the inclusion criteria, of whom 7,225 (64%) were exposed to UDCA at index date. There were 642 COVID-19 related hospitalisations or deaths during follow-up, 402 (63%) among UDCA users. After adjustment, UDCA was associated with a 21% reduction in the hazard of COVID-19 hospitalisation or death (HR 0.79, 95% CI 0.67 to 0.93). Estimated standardised cumulative incidence of the composite outcome was 6.1% (95% CI 5.2% to 7.2%) among users and 7.4% (95% CI 6.2% to 8.8%) among non-users; an absolute difference of -1.35% (95% CI -1.07% to -1.69%). Our results were robust to sensitivity analyses and in secondary analyses, with a similar reduction in hazard seen in the largely vaccinated population (HR 0.71, 95% CI 0·58 - 0·87).

Conclusions: We found evidence that UDCA was associated with a lower hazard of COVID-19 related hospitalisation and death, supporting calls for clinical trials investigating UDCA as a potential preventative measure for severe COVID-19 outcomes in high risk groups.