Journal of Gastroenterology

, Volume 48, Issue 12, pp 1401–1410

Post-transplantation sequential entecavir monotherapy following 1-year combination therapy with hepatitis B immunoglobulin

  • Nam-Joon Yi
  • Jong Young Choi
  • Kyung-Suk Suh
  • Jai Young Cho
  • Minjung Baik
  • Geun Hong
  • Kwang-Woong Lee
  • Won Kim
  • Yoon Jun Kim
  • Jung-Hwan Yoon
  • Hyo-Suk Lee
  • Dong Goo Kim
Original Article—Liver, Pancreas, and Biliary Tract

DOI: 10.1007/s00535-013-0761-x

Cite this article as:
Yi, NJ., Choi, J.Y., Suh, KS. et al. J Gastroenterol (2013) 48: 1401. doi:10.1007/s00535-013-0761-x

Abstract

Background

Combination therapy of intravenous hepatitis B immunoglobulin (ivHBIG) and nucleos(t)ide (NA) analogues is the best post-liver transplantation (LT) prophylactic measure for hepatitis B virus (HBV). However, to reduce the long-term drawbacks of ivHBIG, we evaluated the efficacy of sequential entecavir (ETV) monotherapy.

Methods

Twenty-nine candidates with HBV-related liver disease were prospectively enrolled. The patients were selected if the patient was suitable for one of the following inclusion criteria: (1) NA-naïve patients except for ETV, and (2) negative HB e antigen (HBeAg) and undetectable HBV DNA at the time of LT. Post-LT HBV prophylaxis consisted of 1-year combination therapy with ETV (0.5 mg daily) plus ivHBIG per 5 weeks, followed by ETV monotherapy. The primary endpoint was the 2-year recurrence rate of HB. The median follow-up period was 31 months.

Results

At the time of transplantation, HBeAg was positive in 21 % and HBV DNA was detectable in 52 % of the study participants. No HBV recurrence was reported during the first year. During the second year, HBV recurrence was noted in one who suffered from HCC recurrence without viral mutation. Recurrence free survival rates were 96.6 and 96.4 % at 1- and 2-year post-transplant by intention-to-treat analysis. One patient died of fungal infection.

Conclusion

Sequential ETV monotherapy after 1-year combination therapy might be safe in NA-naïve replicators as well as non-replicators.

Keywords

Hepatitis BLiver transplantationHepatitis B prophylaxisHepatitis B immunoglobulinEntecavir

Abbreviations

ADV

Adefovir dipivoxil

Anti-HBc

Hepatitis B core antibody

Anti-HBe

Hepatitis B e antibody

Anti-HBs

Hepatitis B surface antibody

CHB

Chronic hepatitis B

ETV

Entecavir

HBIG

Hepatitis B immunoglobulin

HBeAg

Hepatitis B e antigen

HBsAg

Hepatitis B surface antigen

HBV

Hepatitis B virus

HCC

Hepatocellular carcinoma

LAM

Lamivudine

LT

Liver transplantation

NA

Nucleos(t)ide analogue

iv

Intravenous

P

Polymerase

PCR

Polymerase chain reaction

S

Surface

Copyright information

© Springer Japan 2013

Authors and Affiliations

  • Nam-Joon Yi
    • 1
  • Jong Young Choi
    • 2
  • Kyung-Suk Suh
    • 1
  • Jai Young Cho
    • 1
  • Minjung Baik
    • 3
  • Geun Hong
    • 1
  • Kwang-Woong Lee
    • 1
  • Won Kim
    • 4
  • Yoon Jun Kim
    • 5
  • Jung-Hwan Yoon
    • 5
  • Hyo-Suk Lee
    • 5
  • Dong Goo Kim
    • 6
  1. 1.Department of SurgerySeoul National University College of MedicineSeoulRepublic of Korea
  2. 2.Department of Internal MedicineCatholic University of Korea, Seoul St. Mary’s HospitalSeoulRepublic of Korea
  3. 3.Department of SurgerySeoul National University HospitalSeoulRepublic of Korea
  4. 4.Department of Internal MedicineSeoul Metropolitan Government, Seoul National University Boramae Medical CenterSeoulRepublic of Korea
  5. 5.Department of Internal Medicine and Liver Research InstituteSeoul National University College of MedicineSeoulRepublic of Korea
  6. 6.Department of SurgeryCatholic University of Korea, Seoul St. Mary’s HospitalSeoulRepublic of Korea