Efficacy and safety of COVID-19 vaccination in patients with cirrhosis

Vladimir Ivashkin; Albina Ismailova; Ksenia Dmitrieva; Roman Maslennikov; Maria Zharkova; Salekh Aliev; Vyacheslav Bakhitov; Vadim Marcinkevich

doi:10.4254/wjh.v14.i7.1470

Efficacy and safety of COVID-19 vaccination in patients with cirrhosis

World J Hepatol. 2022 Jul 27;14(7):1470-1479. doi: 10.4254/wjh.v14.i7.1470.

Authors

Vladimir Ivashkin¹, Albina Ismailova¹, Ksenia Dmitrieva^{1

2}, Roman Maslennikov^{1

2}, Maria Zharkova¹, Salekh Aliev^{3

4}, Vyacheslav Bakhitov³, Vadim Marcinkevich³

Affiliations

¹ Department of Internal Medicine, Gastroenterology and Hepatology, Sechenov University, Moscow 119435, Russia.
² Department of Internal Diseases, Consultative and Diagnostic Center № 2 of Department of Health, Moscow 107764, Russia.
³ Administration, Consultative and Diagnostic Center № 2 of Department of Health, Moscow 107764, Russia.
⁴ The First Hospital Surgery Department, Pirogov Russian National Research Medical University, Moscow 117997, Russia.

Abstract

Background: The clinical efficacy and safety of vaccination against novel coronavirus disease 2019 (COVID-19) in patients with cirrhosis have not been evaluated yet.

Aim: To evaluate the clinical efficacy and safety of vaccination against COVID-19 in patients with cirrhosis.

Methods: This was a retrospective cohort study of patients with cirrhosis. The first cohort included patients vaccinated with Gam-COVID-Vac (Sputnik V); the second one consisted of unvaccinated controls.

Results: The study included 89 vaccinated patients and 148 unvaccinated ones. There were 4 cases of COVID-19 in the vaccinated group and 24 cases in the unvaccinated group (P = 0.035). No severe cases of COVID-19 were revealed in the vaccinated group, while there were 12 ones in the unvaccinated group (P = 0.012) with 10 deaths detected (P = 0.012). The vaccine efficacy was 69.5% (95% confidence interval [CI]: 18.5%-94.4%) against symptomatic cases of COVID-19, 100% (95%CI: 25.1%-100.0%) against severe cases, and 100% (95%CI: 1.6%-100.0%) against death associated with COVID-19. The efficacy of full vaccination with revaccination against symptomatic cases of COVID-19 was 88.3% (95%CI: 48.0%-99.6%). The overall mortality rate was higher in the unvaccinated group than in the vaccinated group (17.1% vs 3.0%; P = 0.001). Higher Child-Turcotte-Pugh class cirrhosis (hazard ratio [HR] = 4.13, 95%CI: 1.82-9.35) and higher age (HR = 1.08, 95%CI: 1.04-1.15) were independent predictors of overall mortality, while vaccination had a protective effect (HR = 0.09, 95%CI: 0.01-0.76). There was no significant difference in liver-related mortality (P = 0.135) or the incidence of liver decompensation (P = 0.077), bleeding esophageal varices (P = 0.397), and vascular events (P = 0.651) between the two groups of patients.

Conclusion: Vaccination against COVID-19 in patients with cirrhosis is effective and safe.

Keywords: Booster; Coronavirus; Revaccination; SARS-CoV-2; Sputnik V; Vaccination.