Response to Vaccination Against Hepatitis B Virus with a Schedule of Four 40-μg Doses in Cirrhotic Patients Evaluated for Liver Transplantation: Factors Associated with a Response

Abstract We performed a retrospective study to evaluate the rate of and factors associated with a response to recombinant hepatitis B virus (HBV) vaccination using 4 intramuscular doses (40 μg) administered at 0, 1, 2, and 6 months among 278 cirrhotic patients being evaluated for orthotopic liver transplantation (OLT). We re-vaccinated 57 non-responders with the same schedule. The 39.2% overall response rate to vaccination included 36% after three and 40.7% after four doses, namely, a median anti-HBs level of 100 IU/mL (range, 10 to 1000 IU/mL). The 51% revaccination response rate achieved a median hepatitis B surface antibody (anti-HBs) level of 99 IU/mL (range, 11 to >1000 IU/mL). Upon univariate analysis, variables associated with a higher response were: better liver function (Child-Pugh class [A, 53.8% B, 33.3%, C, 30.1%; P = .002), Model for End-stage Liver-Disease (MELD) score (11.4 versus 13.6; P = .001]), absence of diabetes (43.6% versus 20.8%; P = .002), presence of isolated hepatitis B core antibody (anti-HBc) positivity (80% versus 37.7%; P = .007), and younger age ( 55 years, 34.1%; P = .031). Upon multivariate logistic regression analysis, lower MELD score (odds ratio [OR]: 0.922; P = .046), absence of diabetes (OR:0.359; P = .008) and isolated anti-HBc positivity (OR:5.826; P = .034) were associated with a higher response. No differences were observed to be associated with gender, weight, body mass index, etiology or tobacco consumption. Among the same patient cohort (n = 79), the responses after the third and fourth doses were 36.7% and 51.9% respectively. In conclusion, the response rate to HBV vaccination in cirrhotic patients evaluated for OLT reached more than 35% among those who received at least 3 doses. It was higher among patients who showed isolated anti-HBc positivity, better liver function, younger age, and non-diabetic status. The fourth dose only increased the response rate by 24% over that obtained after the first three doses, whereas a revaccination achieved a 50% response rate, which probably accounts for revaccination after no response to 3 doses. Vaccination should be introduced against HBV in the early stages of the disease.