ABSTRACT
OBJECTIVE: We aimed to compare the response rates between two different hepatitis B virus vaccination schedules for cirrhotic subjects who were non-responders to the first three 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 randomised at a 1:1 ratio to receive a single 40 µg booster vaccination at month 6 (classical arm) versus an additional round of three new 40 µg doses administered at monthly intervals (experimental arm). The main outcome was the rate of postvaccinal anti-hepatitis B surface antibodies levels ≥10 mIU/mL. RESULTS: Efficacy by ITT analysis was higher in the experimental arm (46.7%) than in the classical one (25%); 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 three logistic regression models indicating equivalent cirrhosis severity. CONCLUSION: For cirrhotic patients, the revaccination of non-responders to the first three dose cycle, with three additional 40 µg doses, achieved significantly better response rates to those obtained with an isolated 40 µg booster dose. TRIAL REGISTRATION NUMBER: NCT01884415.
Subject(s)
End Stage Liver Disease , Hepatitis B , Child , Humans , Immunization, Secondary , Hepatitis B Antibodies , Severity of Illness Index , Hepatitis B/prevention & control , Liver Cirrhosis/complications , Hepatitis B VaccinesABSTRACT
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Subject(s)
Humans , Female , Middle Aged , Hepatorenal Syndrome/drug therapy , Norepinephrine/administration & dosage , Lypressin/pharmacology , Kidney Failure, Chronic/complications , Liver Cirrhosis, Alcoholic/complications , Liver Transplantation , Lypressin/economicsSubject(s)
Adrenergic Agonists/therapeutic use , Hepatorenal Syndrome/drug therapy , Norepinephrine/therapeutic use , Splanchnic Circulation/drug effects , Terlipressin/therapeutic use , Vasoconstrictor Agents/therapeutic use , Albumins/therapeutic use , Diarrhea/chemically induced , Drug Substitution , Female , Hepatorenal Syndrome/etiology , Hepatorenal Syndrome/surgery , Hernia, Umbilical/surgery , Herniorrhaphy , Humans , Liver Cirrhosis, Alcoholic/complications , Liver Transplantation , Middle Aged , Midodrine/therapeutic use , Octreotide/therapeutic use , Postoperative Complications/drug therapy , Postoperative Complications/etiology , Terlipressin/adverse effectsSubject(s)
Carcinoma, Hepatocellular/therapy , Embolization, Therapeutic/adverse effects , Liver Neoplasms/therapy , Pancreatitis, Acute Necrotizing/therapy , Carcinoma, Hepatocellular/complications , Humans , Liver Neoplasms/complications , Male , Middle Aged , Pancreatitis, Acute Necrotizing/complicationsABSTRACT
No disponible