Impact of SARS-CoV-2 vaccination in patients with vascular liver diseases: Observations from a VALDIG multicenter study
Valeria Perez-Campuzano,
Pierre-Emmanuel Rautou,
Thomas Marjot,
Michael Praktiknjo,
Edilmar Alvarado-Tapias,
Laura Turco,
Luis Ibáñez-Samaniego,
Carlos González-Alayón,
Ángela Puente,
Elba Llop,
Macarena Simón-Talero,
Carmen Álvarez-Navascués,
Thomas Reiberger,
Xavier Verhelst,
Luis Tellez,
Johanna Birte Bergmann,
Lara Orts,
Giuseppe Grassi,
Anna Baiges,
Payance Audrey,
Jonel Trebicka,
Candid Villanueva,
Maria Cristina Morelli,
Sam Murray,
Georgina Meacham,
Marc Luetgehetmann,
Julian Schulze zur Wiesch,
Juan-Carlos García-Pagán,
Eleanor Barnes,
Aurélie Plessier,
Virginia Hernández-Gea
Affiliations
Valeria Perez-Campuzano
Barcelona Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clínic, Institut de InvestigacionsBiomèdiques August Pi iSunyer (IDIBAPS), Departament de Medicina I Ciències de la Salut - University of Barcelona, Barcelona. CIBEREHD (Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas). Health Care Provider of the European Reference Network on Rare Liver Disorders (ERN-Rare Liver), Spain
Pierre-Emmanuel Rautou
Université Paris-Cité, Inserm, Centre de recherche sur l'inflammation, UMR 1149, Paris, France; Service d'Hépatologie, AP-HP, HôpitalBeaujon, DMU DIGEST, Centre de Référence des Maladies Vasculaires du Foie, FILFOIE, ERN RARE-LIVER, Clichy, France
Thomas Marjot
Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
Michael Praktiknjo
Department of Medicine B, University of Münster, Germany; Department of Medicine I, University Hospital Bonn, Germany
Edilmar Alvarado-Tapias
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Laura Turco
IRCCS AziendaOspedaliero-Universitaria di Bologna, Italy
Luis Ibáñez-Samaniego
Hospital General Universitario Gregorio Marañon, Madrid, Spain
Carlos González-Alayón
Hospital Universitario de Canarias, Tenerife, Spain
Division of Gastroenterology and Hepatology, Department of Medicine III, Medical University of Vienna, Austria
Xavier Verhelst
Department of Gastroenterology and Hepatology, Ghent University Hospital, Belgium
Luis Tellez
Hospital Universitario Ramón y Cajal, Madrid, Spain
Johanna Birte Bergmann
German Center for Infection Research (DZIF), Partner Site Hamburg-Lübeck-Borstel-Riems, Germany
Lara Orts
Barcelona Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clínic, Institut de InvestigacionsBiomèdiques August Pi iSunyer (IDIBAPS), Departament de Medicina I Ciències de la Salut - University of Barcelona, Barcelona. CIBEREHD (Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas). Health Care Provider of the European Reference Network on Rare Liver Disorders (ERN-Rare Liver), Spain
Giuseppe Grassi
Barcelona Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clínic, Institut de InvestigacionsBiomèdiques August Pi iSunyer (IDIBAPS), Departament de Medicina I Ciències de la Salut - University of Barcelona, Barcelona. CIBEREHD (Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas). Health Care Provider of the European Reference Network on Rare Liver Disorders (ERN-Rare Liver), Spain
Anna Baiges
Barcelona Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clínic, Institut de InvestigacionsBiomèdiques August Pi iSunyer (IDIBAPS), Departament de Medicina I Ciències de la Salut - University of Barcelona, Barcelona. CIBEREHD (Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas). Health Care Provider of the European Reference Network on Rare Liver Disorders (ERN-Rare Liver), Spain
Payance Audrey
Université Paris-Cité, Inserm, Centre de recherche sur l'inflammation, UMR 1149, Paris, France
Jonel Trebicka
Department of Medicine B, University of Münster, Germany
Candid Villanueva
Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Maria Cristina Morelli
IRCCS AziendaOspedaliero-Universitaria di Bologna, Italy
Sam Murray
Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
Georgina Meacham
Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
Marc Luetgehetmann
German Center for Infection Research (DZIF), Partner Site Hamburg-Lübeck-Borstel-Riems, Germany
Julian Schulze zur Wiesch
Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Germany
Juan-Carlos García-Pagán
Barcelona Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clínic, Institut de InvestigacionsBiomèdiques August Pi iSunyer (IDIBAPS), Departament de Medicina I Ciències de la Salut - University of Barcelona, Barcelona. CIBEREHD (Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas). Health Care Provider of the European Reference Network on Rare Liver Disorders (ERN-Rare Liver), Spain
Eleanor Barnes
Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom
Aurélie Plessier
Université Paris-Cité, Inserm, Centre de recherche sur l'inflammation, UMR 1149, Paris, France
Virginia Hernández-Gea
Barcelona Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clínic, Institut de InvestigacionsBiomèdiques August Pi iSunyer (IDIBAPS), Departament de Medicina I Ciències de la Salut - University of Barcelona, Barcelona. CIBEREHD (Centro de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas). Health Care Provider of the European Reference Network on Rare Liver Disorders (ERN-Rare Liver), Spain; Corresponding author. Address: Barcelona Hepatic Hemodynamic Laboratory, Liver Unit, Hospital Clínic, Villarroel 170, Barcelona 08036, Spain. Tel.: +34932275400 (2209), Fax number: +34 932279856.
Background & Aims: Patients with vascular liver diseases (VLD) are at higher risk of both severe courses of COVID-19 disease and thromboembolic events. The impact of SARS-CoV-2 vaccination in patients with VLD has not been described and represents the aim of our study. Methods: International, multicenter, prospective observational study in patients with VLD analyzing the incidence of COVID-19 infection after vaccination, severity of side effects, occurrence of thromboembolic events and hepatic decompensation. In a subgroup of patients, the humoral and cellular responses to vaccination were also analyzed. Results: A total of 898 patients from 14 European centers – part of the VALDIG network – were included, 872 (97.1%) patients received two vaccine doses (fully vaccinated), and 674 (75.1%) three doses. Of the total cohort, 151/898 had a COVID-19 infection prior to vaccination, of whom 9/151 (5.9%) were re-infected. Of the 747/898 patients who were not previously infected, 11.2% (84/747) were diagnosed with a COVID-19 infection during the study period. Two infected patients required intensive care unit admission and infection was fatal in two fully vaccinated patients. Adverse effects were reported in around 40% of patients, with local side effects being the most frequent. During the study period, 31 (3.5%) patients had thromboembolic events and 21 (2.3%) hepatic decompensations. No cases of vaccine-induced thrombocytopenia were reported. Vaccine immunogenicity was assessed in 36 patients; seroconversion reached 100% and IFNy T-cell responses significantly increased post two mRNA-1273 vaccine doses. Conclusion: Patients with VLD seem to have a preserved immune response to SARS-CoV-2 vaccination, which appears to be safe and effective in preventing severe COVID-19 infection. Our study cannot definitively establish a direct link between vaccination and thrombotic events, though the contribution of vaccination as a cofactor in VLD remains to be elucidated. Impact and implications:: Patients with vascular liver disease (VLD) are at increased risk of both SARS-CoV-2 infection and severe COVID-19 disease. The potential risks associated with vaccination against this infection need thorough investigation. Our research enhances the understanding of the effects of COVID-19 vaccination in patients with VLD, highlighting its good tolerability. Moreover, patients with VLD appear to have a preserved immune response to SARS-CoV-2 vaccination, providing protection against severe COVID-19 infection. Our study cannot definitively establish a direct link between vaccination and thrombotic events, and no cases of vaccine-induced thrombocytopenia were reported.