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

  • Original Article—Liver, Pancreas, and Biliary Tract
  • Published:
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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.

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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

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Acknowledgments

A grant from the Korean Association for the Study of the Liver was received for this study.

Conflict of interest

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Department of Surgery, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, Republic of Korea

    Nam-Joon Yi, Kyung-Suk Suh, Jai Young Cho, Geun Hong & Kwang-Woong Lee

  2. Department of Internal Medicine, Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, 137-701, Republic of Korea

    Jong Young Choi

  3. Department of Surgery, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, Republic of Korea

    Minjung Baik

  4. Department of Internal Medicine, Seoul Metropolitan Government, Seoul National University Boramae Medical Center, 20 Boramae-ro 5-gil, Dongjak-gu, Seoul, 156-707, Republic of Korea

    Won Kim

  5. Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, 101 Daehak-ro, Jongno-gu, Seoul, 110-744, Republic of Korea

    Yoon Jun Kim, Jung-Hwan Yoon & Hyo-Suk Lee

  6. Department of Surgery, Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul, 137-701, Republic of Korea

    Dong Goo Kim

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  1. Nam-Joon Yi
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Corresponding author

Correspondence to Kyung-Suk Suh.

Additional information

N.-J. Yi and J. Y. Choi contributed equally to the research and manuscript preparation.

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Yi, NJ., Choi, J.Y., Suh, KS. et al. Post-transplantation sequential entecavir monotherapy following 1-year combination therapy with hepatitis B immunoglobulin. J Gastroenterol 48, 1401–1410 (2013). https://doi.org/10.1007/s00535-013-0761-x

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  • DOI: https://doi.org/10.1007/s00535-013-0761-x

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