Active hepatitis B virus vaccination in the prevention of viral reactivation in liver transplantation recipients with previous hepatitis B infection: a cohort study.

Abstract

Background and aim of the study: For many years, the standard treatment following liver transplantation for hepatitis B has been a combination of hepatitis B immunoglobulin and nucleos(t)ide analogues such as entecavir and tenofovir. However, because of the high costs and logistical challenges of long-term hepatitis B immunoglobulin use, alternative approaches such as vaccination and hepatitis B immunoglobulin-free regimens are being explored. This study gathered information on a potential response (or lack thereof) and addressed the adverse events associated with active immunisation in liver transplant recipients in a Swiss cohort with hepatitis B virus (HBV)-related diseases after discontinuing hepatitis B immunoglobulin.

Methods: Participants were recruited at the University Hospital of Bern between January 2022 and December 2023. Eligibility was restricted to liver transplant recipients with HBV-related disease who were receiving hepatitis B immunoglobulin and nucleos(t)ide analogue therapy at the time of study entry. The primary outcome was HBV relapse following hepatitis B immunoglobulin discontinuation; secondary outcomes included the response rate to active immunisation and reported adverse events. After exclusion, 18 patients were analysed. These patients, under ongoing immunosuppression and antiviral nucleos(t)ide analogue therapy, received active immunisation a minimum of 4 weeks after stopping hepatitis B immunoglobulin. Blood samples were collected at baseline and 4 weeks after vaccination, with follow-up extending for at least 12 months. Responders were defined as those with anti-HB levels of >10 IU/l. All patients received at least three vaccinations.

Results: Six patients responded to the active immunisation with anti-HBs development, showing a response rate of 33.3%. No side effects or HBV recurrence were reported during the study period.

Conclusion: In this cohort, following liver transplantation for hepatitis B, patients who discontinued hepatitis B immunoglobulin while continuing nucleos(t)ide analogue therapy showed no relapse of hepatitis B, and a double-dose vaccination regimen yielded a modest response rate. These findings warrant further investigation into optimising vaccination strategies in this population.