Robert Perrillo has received payment for participating in a speakers' bureau. Maria Buti has provided consultancy services and received lecture fees from Bristol-Myers Squibb and Gilead and is an advisory board member for Bristol-Myers Squibb and Gilead. Francois Durand has provided consultancy services for Novartis, Astellas, and Gilead. Adrian Gadano has received consulting fees, lecture fees, and support for travel from Bristol-Myers Squibb. Juan Carlos Lopez-Talavera, Kimberly Brown, Wenhua Hu, and Cyril Llamoso are Bristol-Myers Squibb employees. Juan Carlos Lopez-Talavera and Cyril Llamoso hold stock/stock options in Bristol-Myers Squibb. Guido Cantisani, Michael Charlton, and Che-Chuan Loong have nothing to disclose.
Entecavir and hepatitis B immune globulin in patients undergoing liver transplantation for chronic hepatitis B
Article first published online: 29 JUL 2013
© 2013 American Association for the Study of Liver Diseases
Volume 19, Issue 8, pages 887–895, August 2013
How to Cite
Perrillo, R., Buti, M., Durand, F., Charlton, M., Gadano, A., Cantisani, G., Loong, C.-C., Brown, K., Hu, W., Lopez-Talavera, J. C. and Llamoso, C. (2013), Entecavir and hepatitis B immune globulin in patients undergoing liver transplantation for chronic hepatitis B. Liver Transpl, 19: 887–895. doi: 10.1002/lt.23690
The study was funded by Bristol-Myers Squibb. Editorial support was provided by Isabelle Kaufmann of Articulate Science and was funded by Bristol-Myers Squibb.
- Issue published online: 29 JUL 2013
- Article first published online: 29 JUL 2013
- Accepted manuscript online: 21 JUN 2013 03:20AM EST
- Manuscript Accepted: 5 MAY 2013
- Manuscript Received: 19 FEB 2013
For patients undergoing liver transplantation (LT) for hepatitis B virus (HBV)–related liver disease, the current standard of care for preventing reinfection of the allograft is nucleoside analogue therapy combined with hepatitis B immune globulin (HBIG). Entecavir has demonstrated high efficacy and a favorable safety profile for chronic hepatitis B (CHB) treatment, but data for patients undergoing HBV-related LT are limited. This study assessed the safety and efficacy of entecavir combined with various HBIG regimens after CHB-related LT. In this phase 3b, single-arm, open-label study, 65 patients undergoing LT for CHB-related liver disease with an HBV DNA load <172 IU/mL at LT received entecavir (1.0 mg daily) for 72 weeks after LT. The primary endpoint was the proportion of evaluable patients (treated for ≥4 weeks) with virological recurrence (HBV DNA level ≥50 IU/mL) through week 72. Concomitant HBIG therapy was received by 64 of the 65 enrolled patients, and 44% of these patients received high-dose HBIG (any HBIG dose in the specified interval ≥10,000 IU). Through week 72, all 61 patients evaluable for the efficacy analysis had undetectable HBV DNA. The Kaplan-Meier estimate of patients without hepatitis B surface antigen (HBsAg) recurrence at week 72 was 0.9655. Two patients experienced a reappearance of HBsAg, but both remained HBV DNA− until the last follow-up. The frequency and nature of adverse events were consistent with those expected for this patient population. Serum creatinine increments ≥0.3 mg/dL and ≥0.5 mg/dL occurred in 62% and 39% of the patients, respectively, and all of these patients received calcineurin inhibitor therapy. In conclusion, in this population of patients treated with entecavir after CHB-related LT, entecavir was well tolerated and effective in maintaining viral suppression, even in individuals who experienced a reappearance of HBsAg. Liver Transpl 19:887–895, 2013. © 2013 AASLD.