A Very Short Course of HBIg+NA Followed by Entecavir or Tenofovir Monotherapy Prevents HBV Recurrence in Low-Risk Liver Transplant Recipients

Transplant Proc. 2021 Jan-Feb;53(1):207-214. doi: 10.1016/j.transproceed.2020.04.1822. Epub 2020 Jun 28.

Abstract

Background: Monoprophylaxis with third-generation nucleos(t)ide analogues (NAs) can be safely adopted in hepatitis B virus (HBV)-positive, liver transplantation (LT) patients after at least 6 months of HBV immunoglobulin (HBIg)+NA. We investigated the efficacy of earlier initiation of post-LT entecavir (ETV) or tenofovir (TDF) monoprophylaxis.

Methods: Between September 2011 and January 2017, all consecutive hepatitis B surface antigen (HBsAg)-positive transplanted patients were scheduled to receive HBIg with ETV or TDF for a period related to the risk for HBV reinfection: 1. low-risk patients (HBeAg-negative and HBV DNA < 12 IU/mL before LT) were due to withdraw from HBIg once HBsAg had become negative after a minimum of 7 days of HBIg+NA; 2. high-risk patients were due to receive HBIg for at least 6 months, after which they continued with third-generation NA monotherapy, only.

Results: Twenty patients with a median interquartile range (IQR) follow-up of 46 (64-39) months were enrolled in the study (40% receiving ETV, 60% receiving TDF). Two low-risk patients refused early HBIg withdrawal and were therefore treated and analyzed along with the high-risk group. Eventually, there were 2 groups: group A, which included 12 low-risk patients, and group B, which included 8 patients (six high-risk, 2 low-risk). After transplantation, group A and B patients received HBIg+NA for a median (IQR) time of 7 (9-7) days and 9 (13-5) months, respectively. All 20 recipients demonstrated HBV DNA < 12 IU/mL and stable graft function during follow-up. Two patients (10%), 1 from each group, had HBsAg relapse. Notably, both patients who relapsed had hepatocellular carcinoma (HCC) diagnosed before LT and showed very low levels (< 0.25 IU/mL) of HBsAg after recurrence.

Conclusion: In low-risk HBsAg-positive recipients, HBIg may be safely discontinued within 2 weeks of LT and replaced by ETV or TDF monotherapy.

MeSH terms

  • Adult
  • Antiviral Agents / administration & dosage*
  • Drug Substitution / methods
  • Female
  • Follow-Up Studies
  • Guanine / administration & dosage
  • Guanine / analogs & derivatives*
  • Hepatitis B / complications
  • Hepatitis B / prevention & control*
  • Hepatitis B virus
  • Humans
  • Immunoglobulins / therapeutic use
  • Liver Transplantation*
  • Male
  • Middle Aged
  • Reinfection / prevention & control*
  • Tenofovir / administration & dosage*
  • Treatment Outcome

Substances

  • Antiviral Agents
  • Immunoglobulins
  • entecavir
  • Guanine
  • Tenofovir
  • hepatitis B hyperimmune globulin