1. Three double-dose reinforced hepatitis B revaccination scheme for patients with cirrhosis unresponsive to the standard regimen: an open-label randomised clinical trial.
- Author
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Giráldez-Gallego Á, Rodríguez-Seguel EDP, Valencia-Martín R, Morillo-García Á, Salamanca-Rivera C, Ruiz-Pérez R, Cuaresma-Duque M, Rosso-Fernández C, Ferrer-Ríos MT, Sousa-Martín JM, Praena-Fernández JM, Desongles-Corrales T, Rodríguez-Pérez A, Camino-Durán F, Gasch-Illescas A, Ampuero-Herrojo J, and Pascasio-Acevedo JM
- Subjects
- Child, Humans, Immunization, Secondary, Hepatitis B Antibodies, Severity of Illness Index, Liver Cirrhosis complications, Hepatitis B Vaccines, End Stage Liver Disease, Hepatitis B prevention & control
- 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., Competing Interests: Competing interests: ÁG-G has received speaker fees from Gilead, Gore, MSD, BMS and Abbvie. MTF-R has received speaker fees from Bayer, Gilead, Abbvie and MSD. JMS-M has received lecture fees from Gilead, Abbvie and Intercept. JA has received speaker fees from Abbvie and Gilead, is an Advisory Board member of Intercept, GMP-Orphan and Novo Nordisk, and is supported by grants from Gilead. JMP-A has received lecture fees from Gilead, Abbvie and Astellas, and is supported by grants from Gilead. For all authors, both fees and grants were unrelated to the submitted work., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
- Published
- 2023
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