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Background & Aims: Obeticholic acid (OCA) has recently been restricted in patients with primary biliary cholangitis (PBC) with "advanced cirrhosis" because of its narrow therapeutic index. We aimed to better define the predicting factors of hepatic serious adverse events (SAEs) and non‐response in cirrhotic patients undergoing OCA therapy. Methods: Safety and efficacy of treatment were evaluated in a cohort of consecutive PBC cirrhotic patients started with OCA. OCA response was evaluated according to the Poise criteria. Risk factors for hepatic SAEs and non‐response were reported as risk ratios (RR) with 95% confidence intervals (CIs). Results: One hundred PBC cirrhotics were included, 97 Child‐Pugh class A and 3 class B. Thirty‐one had oesophageal varices and 5 had a history of ascites. Thirty‐three per cent and 32% of patients achieved a biochemical response at 6 and 12 months respectively. Male sex (adjusted‐RR 1.75, 95%CI 1.42–2.12), INR (1.37, 1.00–1.87), Child‐Pugh score (1.79, 1.28–2.50), MELD (1.17, 1.04–1.30) and bilirubin (1.83, 1.11–3.01) were independently associated with non‐response to OCA. Twenty‐two patients discontinued OCA within 12 months: 10 for pruritus, 9 for hepatic SAEs (5 for jaundice and/or ascitic decompensation; 4 for upper digestive bleeding). INR (adjusted‐RR 1.91, 95%CI 1.10–3.36), lower albumin levels (0.18, 0.06–0.51), Child‐Pugh score (2.43, 1.50–4.04), history of ascites (3.5, 1.85–6.5) and bilirubin (1.30, 1.05–1.56), were associated with hepatic SAEs. A total bilirubin≥1.4 mg/dl at baseline was the most accurate biochemical predictor of hepatic SAEs under OCA. Conclusions: An accurate baseline assessment is crucial to select cirrhotic patients who can benefit from OCA. Although OCA is effective in one third of cirrhotics, bilirubin level ≥1.4 mg/dl should discourage from its use. [ABSTRACT FROM AUTHOR]

Keywords: autoimmune hepatitis; Covid-19 vaccine; drug-induced autoimmune hepatitis EN autoimmune hepatitis Covid-19 vaccine drug-induced autoimmune hepatitis 1204 1205 2 04/25/22 20220501 NES 220501 Abbreviations AIH autoimmune hepatitis AST aspartate aminotransferase ALT alanine aminotransferase ALP alkaline phosphatase GGT gamma-glutamyl transferase CT computerized tomography MRI magnetic resonance imaging IgG immunoglobulins G ANA anti-nuclear antibodies AMA anti-mitochondrial antibodies ASMA anti-smooth muscle antibodies LKM-1 anti-liver-kidney microsomal antibodies ANCA and anti-neutrophil cytoplasmic antibodies UNL upper normal level DI-AIH drug-induced autoimmune hepatitis Several cases of autoimmune hepatitis (AIH) after coronavirus disease 2019 (Covid-19) vaccination have been recently reported.1-4 However, no data to prove a casual relation between vaccine and AIH is still available. She underwent abdominal ultrasound, abdominal computerized tomography (CT) scan and magnetic resonance imaging (MRI), which showed a normal liver, with no signs of chronic liver injury, no signs of gallstones nor alteration of the biliary tree. Autoimmune hepatitis or drug-induced autoimmune hepatitis following Covid-19 vaccination?. [Extracted from the article]

REFERENCES 1 Fimiano F, D'Amato D, Gambella A, Marzano A, Saracco GM, Morgando A. Research letter: autoimmune hepatitis or drug-induced autoimmune hepatitis following Covid-19 vaccination? Shahreedhan et al. concluded that both mRNA and the deactivated adenovirus (i.e. AZD1222) COVID-19 vaccines could trigger immune response and, therefore, determine drug-induced autoimmune hepatitis (DI-AIH) or AIH. In reply to our report,1 we read with interest the letter to the editor by Shahreedhan et al.2 who reported three cases of alterated liver function tests after different COVID-19 vaccine typologies. [Extracted from the article]

LINKED CONTENT This article is linked to Murillo Perez et al paper. To view this article, visit https://doi.org/10.1111/apt.15533. [ABSTRACT FROM AUTHOR]