Liver and Bile
Gut. 2024;73(1):166–74
Three double-dose reinforced hepatitis B revaccination scheme for patients with cirrhosis unresponsive to the standard regimen: An open-label randomized clinical trial
Objective: The aim of this study was to compare the response rates between 2 different hepatitis B virus vaccination schedules for cirrhotic subjects who were non-responders to the first 3 40-µg doses (month 0-1-2), and identify factors associated with the final response.
Design: A total of 120 cirrhotic patients (72.5% decompensated) were randomized at a 1:1 ratio to receive a single 40-µg booster vaccination at month 6 (classical arm) versus an additional round of 3 new 40-µg doses administered at monthly intervals (experimental arm). The main outcome was the rate of postvaccinal anti-hepatitis B surface antibody levels ≥ 10 mIU/ml.
Results: Efficacy by intention-to-treat analysis was higher in the experimental arm (46.7%) than in the classical one (25%); odds ratio [OR] = 2.63; p = 0.013. The experimental arm increased response rates compared with the classical one from 31% to 68% (OR = 4.72; p = 0.007), from 24.4% to 50% (OR = 3.09; p = 0.012) and from 24.4% to 53.8% (OR = 3.62; p = 0.007), in Child A, Model for End-stage Liver Disease (MELD) < 15 and MELD-Na < 15 patients, respectively. Patients with more advanced liver disease did not benefit from the reinforced scheme. Both regimens showed similar safety profiles. Multivariable analysis showed that the experimental treatment was independently response-associated when adjusted across 3 logistic regression models indicating equivalent cirrhosis severity.
Conclusion: For cirrhotic patients, the revaccination of non-responders to the first 3-dose cycle, with 3 additional 40-µg doses, achieved significantly better response rates to those obtained with an isolated 40-µg booster dose.