BARCELONA—Cirrhosis and chronic liver disease are associated with dysregulation of the immune system. Previous studies have demonstrated that patients with cirrhosis are at increased risk of death from COVID-19, but few data exist on immunity following vaccination in cirrhosis and post-liver transplant patients. Recent findings from researchers at the European Foundation for the Study of Chronic Liver Failure (EF CLIF) and collaborators in Spain, Italy, the Netherlands and UK provide evidence of the effectiveness of the vaccine in patients with cirrhosis, autoimmune liver disease or post-liver transplantation.
Maria Pilar Ballester, postdoctoral researcher at the Digestive Disease Department in the Hospital Clínico Universitario de Valencia, Spain, presented data in support of a reduced risk of COVID-19 infection within 12–24 weeks of vaccination in patients with cirrhosis, autoimmune liver disease or post-liver transplant, a sub-study embedded within the COBALT study at the 47th Annual Congress of the Spanish Association for the Study of the Liver (AEEH) that took place on 25–27 May 2022 in Madrid, Spain.
In a cohort of 205 patients which included patients with cirrhosis (31%), autoimmune liver disease (32%) or who received a liver transplant (37%), 3 patients tested positive for SARS-CoV-2 after a second dose of COVID-19 vaccine and only 1 patient required hospitalization. Patients with a history of COVID-19 were excluded from the sub-study and clinical factors such as sex, etiology, or immunosuppressive treatment appeared not to be associated with the risk of infection. No relationship was found between infection and prognosis of cirrhosis based on the MELD and Child-Pugh scores – two scores that are traditionally used to assess the severity of liver dysfunction and predict patient survival. Biochemical markers of liver or kidney function were not significantly associated with the risk of infection either.
"These results are among the first prospective data for COVID-19 vaccine efficacy for chronic liver disease and liver transplant patients, and as such, should be interpreted with caution", explained Ballester. "In our sample, the short-term risk of COVID-19 infection in vaccinated patients was 1.5%, which is lower than that reported in retrospective studies", she added. Besides these promising results, further analysis of our data will help to identify the actual risk of infection in patients with chronic liver disease, the durability of protection against the virus after COVID-19 vaccination and timing to get a vaccine booster dose.
Ballester's abstract was selected to be presented to the broader audience of the congress in a poster blast session.
The COBALT study is sponsored by EF CLIF and M.P.B. supported by a Río Hortega grant (CM19/00011) from the Instituto de Salud Carlos III.
Other authors on the study are Javier Ampuero, Salvatore Piano, Ângela Carvalho-Gomes, Elena Diago-Sempere, María del Carmen Rico, Eva Román, Iván Sahuco, Yolanda Sánchez, Elisabet Sánchez, Ariadna Bono, Vicente Arroyo, Paolo Angeli, Cristina Sánchez, Eva Usón, Shilpa Chokshi, Rajni Sharma, Antonio Riva, Amir Gander, Germán Soriano, José Luis Calleja, Marina Berenguer, Rajiv Jalan, and Gautam Mehta.
Ballester, M.P., Ampuero, J.; Piano, S.; Carvalho-Gomes, A.; Diago-Sempere, E.; Rico, M.d.C.; Román, E.; Sahuco, I.; Sánchez, Y.; Sánchez, E.; Bono, A.; Arroyo, V.; Angeli, P.; Sánchez, C.; Usón, E.; Chokshi, S.; Sharma, R.; Riva, A.; Gander, A.; Soriano, G.; Calleja, J.L.; Berenguer, M.; Jalan, R., Mehta, G. Risk of COVID-19 infection within 12–24 weeks of vaccination in patients with cirrhosis, autoimmune liver disease or post-liver transplant: A COBALT sub-study. In Book of Abstracts, 47º Congreso Anual de la Asociación Española para el Estudio del Hígado (AEEH2022), Madrid, Spain; Poster 38.
About the COBALT study
The aim of the COBALT study is to determine the protective effect of COVID-19 vaccination in liver disease. This study aims to compare responses after a 2-dose and 3-dose of the vaccine with healthy controls, to look at the level of antibody response. The durability of response and degree of protection against COVID-19 are also investigated.
About EF CLIF
The European Foundation for the Study of Chronic Liver Failure (EF CLIF) is a private non-profit organization connecting biomedical researchers and healthcare professionals with each other, with patients and patient associations, and with society. The fundamental purpose of EF CLIF, reflected in its founding Statements of 2015, is to advance knowledge and promote research and education in liver disease to improve the prognosis of patients living with chronic liver failure.
The Foundation has made pioneering efforts in conducting a series of large, international prospective studies that have been instrumental in reclassifying the trajectory of patients with chronic liver failure and led to the clinical, prognostic and pathophysiological definition of the syndrome referred to as “acute-on-chronic liver failure” characterized by acute decompensation of cirrhosis, severe systemic inflammation, organ failures, and high short-term mortality. We are inspiring best clinical practices for the management of patients with chronic liver failure and promoting a more sustainable and equitable healthcare system.
Within the Foundation, the European Association for the Study of the Liver (EASL) Chair supports research activities through the EASL-CLIF Consortium, a network of 117 tertiary care and university hospitals in 28 European countries. The Grifols Chair promotes translational studies in centers across Europe and North America within the framework of the European Network for Translational Research (ENTR) with 25 centers in 8 countries. Over the last five years, the Foundation has successfully expanded its geographical scope providing the context to support transcontinental collaborative research projects. The Global Projects chapter provides the framework to promote research in cirrhosis across the world with the aim to help to build consensus and ensure health equity worldwide.Download attached document (145,67 KB)