Bezafibrate therapy in primary biliary cholangitis refractory to ursodeoxycholic acid: a longitudinal study of paired liver biopsies at 5 years of follow up

SORDA JUAN ANTONIO; GONZALEZ BALLERGA, ESTEBAN; BARREYRO, FERNANDO J.; AVAGNINA ALEJANDRA; CARBALLO PILAR; PAES DE LIMA ANDREA; DARUICH JORGE

ALIMENTARY PHARMACOLOGY & THERAPEUTICS.

WILEY-BLACKWELL PUBLISHING, INC

Lugar: Londres; Año: 2021

0269-2813

Background: Ursodeoxycholic acid (UDCA) is the first line therapy for primary biliary cholangitis (PBC). However, nearly 40% patients have incomplete response to UDCA. The addition of Bezafibrate (BZF) has been shown biochemical benefit in this group of patients.Aim: to evaluate long-term effects of UDCA in combination with BZF on histological outcome in PBC patient?s refractory to UDCA. Methods: This study was a prospective analysis of 59 consecutive patient refractory to UDCA therapy. Clinical parameters were monitored and paired liver biopsy was performed after 5 years of follow-up. Results: Of the total cohort, 49 subjects were followed-up for 5 years and 31 accepted to undergo paired liver biopsies. Values for serum APh, AST, ALT and GGT significantly improved under BZF treatment, this beneficial effect was clearly observed at 12 months where 86% of subjects achieved APh at normal levels. Analyses of paired liver biopsies showed a significant decrease after 5 years of UDCA-BZF therapy in Ludwig score (baseline 2,29 ± 1,2, to 1.84 ± 1 at year-5, p 0,0242) and Ishak score (baseline 6,19 ± 2,2 to 4,77 ± 2,2 at year-5, p 0,0008). Overall, regression of fibrosis was addressed in 48% of patients, noteworthy a significant reduction of proportion of cirrhosis was observed from 19% at baseline to 3% at 5 years (p< 0,001). This beneficial effect at biochemical and histological level was associated in better predictive risk of events using the GLOBE and UK-PBC model.