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. 2026 Jan 29.
doi: 10.1097/MEG.0000000000003142. Online ahead of print.

Clinical course and prognostic risk factors of SARS-CoV-2 vaccine-related hepatitis: differentiating severe acute respiratory syndrome coronavirus 2 vaccine-associated liver injury from autoimmune hepatitis

Donald Malino  1 , Greta Codoni  2 , Theresa Kirchner  3   4 , Bastian Engel  3   4 , Alejandra Maria Villamil  5 , Cumali Efe  6 , Albert Friedrich Stättermayer  7 , Jan Philipp Weltzsch  4   8 , Marcial Sebode  4   8 , Christine Bernsmeier  9 , Ana Lleo  10 , Tom J G Gevers  4   11 , Limas Kupčinskas  4   12 , Agustin Castiella  13 , Jose Pinazo  14 , Eleonora De Martin  15 , Ingrid Bobis  16 , Thomas Damgaard Sandahl  17 , Federica Pedica  18 , Federica Invernizzi  19 , Paolo Del Poggio  19 , Tony Bruns  4   20 , Mirjam Kolev  21 , Nasser Semmo  21 , Fernando Bessone  22 , Baptiste Giguet  23 , Guido Poggi  24 , Masayuki Ueno  25   26 , Helena Jang  27 , Gülsüm Özlem Elpek  28 , Neşe Karadağ Soylu  29 , Andreas Cerny  1 , Heiner Wedemeyer  3   4 , Matthias S Matter  30 , Sarp Uzun  30 , Gonzalo Matilla-Cabello  14 , Diego Vergani  31 , Giorgina Mieli-Vergani  31 , M Isabel Lucena  14   32 , Raul J Andrade  14   33 , Yoh Zen  31 , Richard Taubert  3   4 , Benedetta Terziroli Beretta-Piccoli  1   2   31   33
Affiliations

Clinical course and prognostic risk factors of SARS-CoV-2 vaccine-related hepatitis: differentiating severe acute respiratory syndrome coronavirus 2 vaccine-associated liver injury from autoimmune hepatitis

Donald Malino et al. Eur J Gastroenterol Hepatol. .

Abstract

Background and aim: Reported cases of acute liver injury with autoimmune features post-COVID-19 vaccination raise questions about whether this represents vaccine-triggered autoimmune hepatitis (AIH) or self-limiting drug-induced autoimmune-like hepatitis (DI-ALH). We report follow-up data to determine if the disease course is self-limiting or immunosuppression-dependent.

Methods: Members of the International AIH Group and the European Reference Network on Hepatological Diseases who contributed cases to our original cohort provide follow-up data at 6 months, 12 months, and at last follow-up.

Results: Sixty-two patients (median age 56 years, 35 female) were included (median follow-up: 22.8 months). Fifty-eight (93%) received steroids ± azathioprine/mycophenolate. Four died of non-liver-related causes. Transaminases normalization rates were 71, 92, and 90% at 6 months, 12 months, and last follow-up, respectively. Twenty-four had a DI-ALH-like course, with ALT normalization and no relapse with or without (n = 4) a short (<9 months) immunosuppressive treatment. Nineteen had an AIH-like course, with relapse after discontinuation (n = 11) or persistent ALT elevation despite treatment (n = 8). Nineteen were unclassified. Risk factors for AIH-like progression included a higher revised AIH score, advanced fibrosis, and severe interface hepatitis.

Conclusion: Most cases resemble DI-ALH, which we propose naming severe acute respiratory syndrome coronavirus 2 vaccine-associated liver injury, but a significant subset requires long-term immunosuppression, resembling classical AIH.

Keywords: COVID-19 vaccines; autoimmune hepatitis; follow-up; severe acute respiratory syndrome coronavirus 2 vaccine-associated liver injury; vaccine-induced hepatitis.

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