Entecavir and hepatitis B immune globulin in patients undergoing liver transplantation for chronic hepatitis B

• Published in: Liver transplantation Vol. 19; no. 8; pp. 887 - 895
• Main Authors: Perrillo, Robert, Buti, Maria, Durand, Francois, Charlton, Michael, Gadano, Adrian, Cantisani, Guido, Loong, Che‐Chuan, Brown, Kimberly, Hu, Wenhua, Lopez‐Talavera, Juan Carlos, Llamoso, Cyril
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.08.2013; Blackwell Publishing Ltd
• Subjects: Adult; Antiviral Agents - therapeutic use; Calcineurin Inhibitors; Creatinine - blood; Deoxyribonucleic acid; DNA; DNA, Viral - analysis; Drug therapy; Female; Guanine - analogs & derivatives; Guanine - therapeutic use; Hepatitis; Hepatitis B Surface Antigens - blood; Hepatitis B virus; Hepatitis B, Chronic - therapy; Humans; Immunoglobulins - therapeutic use; Liver diseases; Liver Failure - therapy; Liver Transplantation - methods; Male; Middle Aged; Original
• ISSN: 1527-6465; 1527-6473
• DOI: 10.1002/lt.23690

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.