Breakthrough SARS‐CoV‐2 infection outcomes in vaccinated patients with chronic liver disease and cirrhosis: A National COVID Cohort Collaborative study

Abstract

Background and Aims Outcomes of breakthrough SARS‐CoV‐2 infections have not been well‐characterized in non‐veteran vaccinated chronic liver disease (CLD) patients. We used the National COVID Cohort Collaborative (N3C) to describe these outcomes. Methods We identified all CLD patients with or without cirrhosis who had SARS‐CoV‐2 testing in the N3C Data Enclave as of 1/15/2022. We used Poisson regression to estimate incidence rates of breakthrough infections and Cox survival analyses to associate vaccination status with all‐cause mortality at 30 days among infected CLD patients. Results We isolated 278,457 total CLD patients: 43,079 (15%) vaccinated and 235,378 (85%) unvaccinated. Of 43,079 vaccinated patients, 32,838 (76%) were without cirrhosis and 10,441 (24%) with cirrhosis. Breakthrough infections incidences were 5.4 and 4.9 per 1,000 person‐months for fully vaccinated CLD patients without cirrhosis and with cirrhosis, respectively. Of the 68,048 unvaccinated and 10,441 vaccinated CLD patients with cirrhosis, 15% and 3.7%, respectively, developed SARS‐CoV‐2 infection. The 30‐day outcome of mechanical ventilation or death after SARS‐CoV‐2 infection for unvaccinated and vaccinated CLD patients with cirrhosis were 15.2% and 7.7%, respectively. Compared to unvaccinated patients with cirrhosis, full vaccination was associated with a 0.34‐times adjusted hazard of death at 30 days. Conclusions In this N3C study, breakthrough infection rates were similar amongst CLD patients with and without cirrhosis. Full vaccination was associated with a 66% reduction in risk of all‐cause mortality for breakthrough infection among CLD patients with cirrhosis. These results provide an additional impetus for increasing vaccination uptake in CLD populations.

Impact of chronic liver disease on SARS-CoV-2 infection outcomes: Roles of stage, etiology and vaccination

“…The benefit of vaccination is also statistically significant in patients with decompensated cirrhosis and in those who have not completed the vaccination course[ 103 ]. Similar results have been reported also by Ge et al [ 104 ], whose study is available only in “pre-print” version to date. This study, carried out during SARS-CoV-2 alpha and delta variants predominance, describes a 66% reduction in 30-d mortality in vaccinated cirrhotic patients compared to unvaccinated patients with liver cirrhosis.…”

“…Beyond humoral response, little data are available on clinical efficacy of anti-SARS-CoV-2 vaccines in patients with CLD. The most important knowledge on this issue have been acquired from Veterans Outcomes and Costs Associated with Liver Disease cohort[ 103 ] and National COVID Cohort Collaborative registers[ 104 ]. In the first study, John et al [ 103 ] compared overall and COVID-19-related mortality 60 d after SARS-CoV-2 infection in cirrhotic patients receiving mRNA vaccine and cirrhotic patients not previously vaccinated.…”

SARS-CoV-2 and the liver: clinical and immunological features in chronic liver disease

“…SARS-CoV-2-associated mortality increases in parallel with the Child-Pugh score and is higher in patients with decompensated compared with compensated cirrhosis 45 48. However, mortality is reduced in fully vaccinated compared with unvaccinated cirrhotics 49…”

COVID-19 and Liver Disease: An Evolving Landscape

“…Retrospective analysis of the Veterans Health System 126 demonstrated modest 64.8% and 78.6% reduction in COVID-19 infections after first and second dose, respectively, but excellent reduction in COVID-19 related hospitalization and mortality. Similarly, in a recent large National COVID Cohort Collaborative, 127 full vaccination was associated with 66% mortality risk reduction with a 0.34 adjusted hazard of death at 30 days compared to unvaccinated cirrhotic patients. There is a lack of studies assessing the clinical outcomes of COVID-19 vaccination in liver transplant (LT) recipients.…”