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Hepatitis B Prophylaxis for Non-Thoracic Solid Organ Transplant – Adult - Inpatient

Hepatitis B Prophylaxis for Non-Thoracic Solid Organ Transplant – Adult - Inpatient - Clinical Hub, UW Health Clinical Tool Search, UW Health Clinical Tool Search, Clinical Practice Guidelines, Infection and Isolation


1
Hepatitis B Prophylaxis for
Non-Thoracic Solid Organ Transplant –
Adult – Inpatient
Clinical Practice Guideline
Note: Active Table of Contents – Click to follow link
SCOPE ...................................................................................................................................... 3
METHODOLOGY ...................................................................................................................... 4
DEFINITIONS ............................................................................................................................ 5
INTRODUCTION ....................................................................................................................... 6
RECOMMENDATIONS .............................................................................................................. 6
TABLE 2. HEPATITIS B PROPHYLAXIS FOR NON-THORACIC SOLID ORGAN
TRANSPLANT RECIPIENTS – QUICK REFERENCE .............................................................. 8
UW HEALTH IMPLEMENTATION ............................................................................................. 9
APPENDIX A. EVIDENCE GRADING SCHEME .....................................................................10
REFERENCES .........................................................................................................................11
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2
Contact for Content
David Hager, PharmD, BCPS
Phone Number: 608-890-8993
Email Address: DHager@uwhealth.org

Contact for Changes
Philip Trapskin, PharmD, BCPS; Drug Policy Program Manager
Phone Number: 608-265-0341
Email Address: PTrapskin@uwhealth.org

Guideline Authors: Margaret R Jorgenson, PharmD, BCPS; David Hager, PharmD, BCPS;
Joshua Vanderloo, PharmD, BCPS, Drug Policy Program

Coordinating Team Members: Joshua Vanderloo, PharmD, BCPS, Drug Policy Program

Review Individuals/Bodies:
Adnan Said, MD – Transplant Hepatology
Joshua Mezrich, MD – Transplant Surgery
Jaime Myers, RN – Manager, Liver Transplant Coordinator
Kristine Matson, MD – Transplant Infectious Disease
Dawd Siraj, MD – Transplant Infectious Disease
David Yang, MD – Medical Director UW Health Clinical Laboratories

Committee Approvals/Dates:
Antimicrobial Use Subcommittee, March 2017
Pharmacy and Therapeutics, March 2017

Release Date: March 2017

Next Review Date: March 2019
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3
Executive Summary
Guideline Overview
This document is intended to guide clinicians in ordering prophylaxis for hepatitis B in adults who have
received a non-thoracic solid organ transplant. Guidance for both liver and non-liver transplant recipients
is included.

Key Revisions January 2016
1. Addition of entecavir to guideline in management of some patients.
2. Additional indications to consult Hepatology in patients receiving HBcAb positive non-thoracic solid
organ transplant

Key Practice Recommendations
Therapeutic options addressed in this guideline include selection and dosing of the following medications
for the management of HBV prophylaxis following non-thoracic solid organ transplant:
1. Hepatitis B Immune Globulin (HBIG) (HepaGam B®)
2. Lamivudine (Epivir HBV® and Epivir®)
3. Entecavir (Baraclude®)

Companion Documents
• Renal Function-based Dose Adjustments – Adult – Inpatient/Ambulatory Clinical Practice Guideline
• Renal Function-Based Dose Adjustment - Adult – Inpatient/Ambulatory Delegation Protocol [8]
• Hepatitis B Prophylaxis for Non-Thoracic Solid Organ Transplant – Adult – Inpatient Delegation
Protocol [118]

Scope
Disease/Conditions: Non-thoracic solid organ transplant

Clinical Specialty: Transplant, Pharmacy

Intended Users: Transplant surgeons, transplant hepatologists, transplant nephrologists, pharmacists,
and transplant coordinators

CPG objectives: To guide the use of hepatitis B prophylaxis in adult patients who have received a non-
thoracic solid organ transplant. Guidance for hepatitis B prophylaxis will be evaluated based on donor and
recipient HBV serologies.

This guideline will review hepatitis B prophylaxis in non-thoracic solid organ transplant and will aim to
provide clinical support in selecting a regimen for prophylaxis that is best suited based on recipient and
donor serologic status.

Target Population: Adult patients who have received a non-thoracic solid organ transplant and the donor
and/or recipient have serologic evidence of hepatitis B infection or past exposure.

Interventions and Practices Considered:
This guideline makes recommendations for the use, dosing and administration of hepatitis B immune
globulin (HBIG) and antivirals in patients with or at risk for contracting hepatitis B through non-thoracic
transplantation.

Major Outcomes Considered:
• Rates of hepatitis B recurrence post-transplant
• Rates of de novo hepatitis B post-transplant
• Resistance rates
• Treatment cost
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
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4

Methodology
Methods Used to Collect/Select the Evidence:
MEDLINE was searched using the terms hepatitis B prophylaxis, liver transplant, renal transplant,
hepatitis B immune globulin, lamivudine, and entecavir. References from identified articles were further
evaluated. Expert opinion and clinical experience were considered during discussions of the evidence.

Methods Used to Formulate the Quality of the Evidence/Strength of the Recommendations:
The workgroup members arrived at a consensus through discussion of the literature and expert
experience. All recommendations endorsed or developed by the guideline workgroup were reviewed and
approved by other stakeholders or committees. Internal expert opinion was also incorporated into
guideline development in cases of a lack of evidence or conflicting evidence.

Methods Used to Assess the Quality and Strength of the Evidence and Recommendations:
Internally developed recommendations were evaluated by the guideline workgroup using an algorithm
adapted from the Grading of Recommendations Assessment, Development and Evaluation (GRADE)
methodology (see Figure 1 in Appendix B).
1


Rating Scheme for the Strength of the Evidence/Recommendations:
See Appendix B for the rating schemes used within this document.

Cost Analysis:
Cost Analysis

(as of December 2016)

Medication Cost
Hepatitis B immune globulin (312 units/mL)
$138/312 units (1 mL vial)
$605/1560 units (5 mL vial)
Lamivudine 100 mg $9.13/tablet
Entecavir 0.5 mg or1 mg
$12.36/0.5 mg tablet
$15.07/1 mg tablet

Recognition of Potential Health Care Disparities: None identified
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
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5
Definitions
2

Abbreviation Definition
HealthLink
Test Code
Comments
HBV Hepatitis B virus
HBIG
Hepatitis B
immunoglobulin
Hepatitis B immunoglobulin Lexicomp monograph
HBsAg
Hepatitis B surface
antigen
HBSAG
• Surface protein found on hepatitis B virus
• Presence is indicative of an infectious person
• It may be elevated in both acute and chronic
infection
• Measured by Hepatitis B Surface Ag (HBSAG)
HBsAb
Hepatitis B surface
antibody
HBSABI
• An antibody against hepatitis B viral surface
antigen
• Presence is indicative of either
o Protective immunity from vaccination
o Successful recovery and immunity from active
infection
• Measured by Hepatitis B Surface Ab (HBSABI)
HBcAb
Hepatitis B core
antibody
HBCAB
• Antibody present at onset of acute infection and
persists for life
• Presence is indicative of infection with HBV in an
undefined time frame
• Hepatitis B core antibody measured by Hepatitis B
Core Ab, Total (HBCAB)
HBcAb-IgM
IgM antibody to
hepatitis B core
antigen
XHBCM
• IgM antibody to hepatitis B core antigen indicates
infection occurring in the last 6 months
• Hepatitis B core antibody IgM measured by
Hepatitis B Core Ab, IgM (XHBCM)
HB quant
PCR
Hepatitis B DNA,
Ultra Quant, PCR
XHBVD
• Quantitative measure of active viral replication
o Active infection: >20000 IU/mL
o Chronic infection: 2000-20000 IU/mL
o Inactive carrier: <2000 IU/mL
• Measured by Hepatitis B DNA, Ultra Quant, PCR
(XHBVD)
CrCL
Creatinine
clearance

As defined in UWHC Guidelines for Renal Function-
Based Dose Adjustments in Adult Inpatients

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6
Introduction
Hepatitis B virus (HBV) infection is the leading cause of chronic hepatitis, cirrhosis and hepatocellular
carcinoma worldwide.
2
The early transplant experience with HBV positive patients resulted in universal
recurrence and frequent graft loss due to the lack of prophylactic strategies.
3-5
The introduction of
hepatitis B immunoglobulin (HBIG) and oral antiviral therapy have drastically reduced recurrence rates of
HBV infection.
6
As the gap between donor availability and recipient demand continues to rise, efforts have
been made to use HBV core antibody positive but hepatitis B surface antigen negative organs.
7,8
Early
studies found a risk of hepatitis B transmission between 15 to 95% in liver recipients with HBV exposed
allografts.
9,10
However, when HBIG and/or antiviral agents are used comparable rates of patient and graft
survival to patients without donors with HBV exposure have been demonstrated.
11-13
The primary concern
with use of HBV core positive grafts is the risk of de novo HBV infection. Without antiviral prophylaxis, de
novo HBV infection rates range from 15% in the hepatitis-B-core-antibody-positive/ hepatitis-B-surface-
antibody-positive liver recipient to approximately 50% in those without exposure (hepatitis B core
antibody negative/hepatitis B surface antibody negative).
14
A combination of HBIG and lamivudine can
reduce rates of de novo HBV infection to approximately 2.5% in those without exposure. When the newly
developed potent antivirals with high barriers to genetic resistance entecavir or tenofovir are used in place
of lamivudine de novo HBV incidence decreases to 1% or lower.
15
This risk increases in the setting of
non-compliance with oral antiviral prophylaxis. Emphasis should be placed on education and strict
compliance with prophylactic strategies to decrease the risk of de novo and lamivudine-resistant infection
in the recipient.
16


The risk of HBV transmission in non-liver organs is lower but prophylaxis is still recommended. Early
studies estimate the risk of transmission from hepatitis B core antibody (HBcAb) positive donors is zero to
27% for renal transplant recipients depending on the recipient’s immunity at the time of transplant. Using
prophylaxis strategies the risk of de novo HBV post renal transplant can essentially be negated.
17-20


It is noteworthy that there is a lack of consensus regarding appropriate hepatitis B prophylaxis post-
transplant and various levels of evidence associated with indications, therefore, these guidelines are
based on current evidence and local expert opinion.

Recommendations

Recipient Laboratory Testing Pretransplant (UWHealth Strong Recommendation, Low Quality of
Evidence)
1. Standard lab orders for transplant recipient:
1.1. Hepatitis B surface antigen (HBsAg)
1.2. Hepatitis B surface antibody (HBsAb)
1.3. Hepatitis B core antibody (HBcAb)
2. Additional labs for patients with positive HBcAb or HBsAg
2.1. IgM antibody to hepatitis B core antigen (HBcAb-IgM)
2.2. Hepatitis B DNA, Ultra Quant, PCR

Donor Laboratory Testing (UWHealth Strong Recommendation, Low Quality of Evidence)
1. Hepatitis B surface antigen (HBsAg)
2. Hepatitis B surface antibody (HBsAb)
3. Hepatitis B DNA, Ultra Quant, PCR (living donor)
4. If possible, the deceased donor liver should be biopsied and assessed for HBV DNA. However, a
negative result does not rule out the possibility of the presence of HBV.
17


Liver Recipient Transplanted for Hepatitis B Liver Disease or with Active HBV Disease at Time of
Transplant (donor HBcAb [+/-], recipient HBcAb [+], HBsAg [+], or with HB quant PCR >2000
IU/mL)
14,21-23

1. HBIG 10000 units IV once during anhepatic phase (UWHealth Strong Recommendation, Moderate
Quality of Evidence)
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7
2. HBIG 800 units IM (rounded to nearest vial size) daily on postoperative days one through seven; then
monthly for at least 12 months or a duration at the discretion of Hepatologist. (UWHealth Strong
Recommendation, Moderate Quality of Evidence)
3. Renally adjusted oral entecavir.
24
(UWHealth Strong Recommendation, Moderate Quality of
Evidence)
4. Surveillance labs should be drawn monthly for 6 months, then every 2 months for 6 months, then
every 3 months for 1 year, and then yearly (when monthly HBIG IM injections are discontinued restart
lab cycle with monthly labs):
4.1. Hepatitis B surface antigen (HBsAg)
4.2. Hepatitis B surface antibody (HBsAb)
4.3. Hepatitis B DNA, Ultra Quant, PCR

Patients receiving HBcAb positive non-thoracic solid organ transplant
8,19,20,24,25

1. Upon admission for receipt of HBcAb-positive organ transplant the following labs should be obtained
in the recipient:
1.1. Hepatitis B core antibody (HBcAb)
1.2. Hepatitis B surface antibody (HBsAb)
1.3. Hepatitis B surface antigen (HBsAg)
2. Each patient should be prescribed the appropriate anti-viral therapy based on Table 1. (UWHealth
Strong Recommendation, Moderate Quality of Evidence)
3. Hepatology should be consulted if there is evidence of active HBV infection at time of presentation for
non-thoracic solid organ transplant. (UWHealth Strong Recommendation, Very Low Quality of
Evidence)
3.1. This includes HBsAg positive or Hepatitis B DNA, Ultra Quant, PCR >2000 IU/mL.
4. HBsAg, HBsAb, HBcAb, and hepatitis B DNA, Quant, PCR should be drawn at 1 and 3 months post-
transplant. Results should be discussed at first clinic visit with a hepatologist to determine a treatment
plan for continued laboratory monitoring and anti-viral therapy. Donor liver biopsy results may also be
used to make treatment decisions. (UWHealth Strong Recommendation, Low Quality of Evidence)

Hepatitis B core antibody positive recipients of any non-thoracic solid organ transplant (Donor
HBcAb (-), Recipient HBcAb (+)
8,25

1. Renally adjusted oral entecavir should be prescribed for all patients at the prophylactic dose.
(UWHealth Strong Recommendation, Low Quality of Evidence)


Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
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8
Table 1. Hepatitis B Prophylaxis for non-thoracic Solid Organ Transplant Recipients – Quick Reference
DONOR
Status
RECIPIENT Status

HBcAb
A
HBcAb
A
HBsAb
B
HBsAg
C
Interpretation of Donor Status and
Recipient Status
Prophylactic Regimen
POS NEG NEG NEG
Recipient has no protective
immunity and is susceptible to
infection
Liver allograft
(1) HBIG 10000 units IV once during anhepatic phase
(2) Entecavir indefinitely
(3) Provide HBV vaccine at the 6 months transplant follow-up appointment
Renal/pancreas allograft
(1) HBIG 10000 units IV once intraoperatively
(2) Entecavir for one year
(3) Provide HBV vaccine at the 6 months transplant follow-up appointment
POS POS POS NEG Immune due to natural infection Entecavir for one year
D
POS NEG POS NEG Immune due to vaccination
Liver allograft: entecavir indefinitely
Non-liver allograft: entecavir for one year
POS or
NEG
POS NEG POS
Acute or chronically infected

Use IgM antibody to hepatitis B
core antigen (HBcAb-IgM) to
determine stage:
• If IgM POS  acute infection
• If IgM NEG  chronic infection
Liver allograft
(1) HBIG 10000 units IV once during anhepatic phase
(2) HBIG 800 units IM (rounded to nearest vial size) daily on postoperative days one through
seven; then monthly for at least 12 months or a duration at the discretion of Hepatologist
(3) Entecavir indefinitely
Renal/pancreas allograft
Chronic: Entecavir indefinitely
Acute: consult Hepatology
POS or
NEG
POS NEG NEG
Four possibilities:
1. Resolved infection (“inactive
carrier” state)
2. False POS Hep B core antibody
3. “Low level” chronic infection
4. Resolving acute infection
All allografts
(1) Repeat HBV serologies (HBcAb, HBsAb, HBsAg, Hepatitis B DNA)
(2) Entecavir, consult Hepatology for duration
(3) In the setting of lymphocyte deplentionary induction (thymoglobulin, alemtuzumab) where risk
of reactivation of recipient HBV is high, consider HBIG 10000 units once intraoperatively
Liver allograft
(1) If donor HBcAb NEG: entecavir x 3 months. HBV vaccination at 6 months
(2) If donor HBcAb POS: HBIG 10000 units IV once during anhepatic phase, entecavir indefinitely.
HBV vaccination at 6 months.
A
Hepatitis B core antibody (HBcAb): This antibody is present at onset of acute infection and persists for life. Its presence indicates infection with Hepatitis B virus in an undefined time
frame. To further delineate the infectious time line, an IgM antibody to hepatitis B core antigen can be ordered. If positive, this would indicate acute infection (infection occurring in
the last 6 months).
B
Hepatitis B surface antigen antibody (HBsAb): The body produces antibodies against hepatitis B surface antigen. The presence of HBsAb indicates either protective immunity from
vaccination or successful recovery from active infection with subsequent immunity. Protective immunity corresponds to HBsAb >100 mIU/mL.
C
Hepatitis B surface antigen (HBsAg): This is a protein found on the surface of the hepatitis B virus. Its laboratory presence indicates an infectious person. It can be elevated in both
acute and chronic infection.
D
For liver allografts, check HBsAb status of recipient at one year and discontinue entecavir only if HBsAb> 10 mIU/mL.
Copyright © 2017 University of Wisconsin Hospitals and Clinics Authority
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9
UW Health Implementation
Potential Benefits:
The predominant benefit of implementation of this guideline is the standardize care for hepatitis B
prophylaxis after transplantation of a non-thoracic solid organ.

Potential Harms:
The risk of implementing this guideline and administering HBIG and/or lamivudine is increased risk of
infusion-related reactions and neutropenia.

Qualifying Statements:
There is a lack of consensus regarding the appropriate hepatitis B prophylaxis regimen post-transplant
and various levels of evidence, therefore, these guidelines are based on current evidence and local
expert opinion. The recommendations included in this guideline are subject to change with publication of
additional evidence.

Guideline Metrics:
• Adherence to evidence based utilization of HBIG
• Recurrent and de novo hepatitis B rates post-transplant

Implementation Plan/Tools
1. Guideline will be posted on U-Connect in a dedicated location for Clinical Practice Guidelines.
2. Release of the guideline will be advertised in the Physician/APP Briefing newsletter.
3. Content and hyperlinks within clinical tools, documents, or Health Link related to the guideline
recommendations (such as the following) will be reviewed for consistency and modified as
appropriate.

Disclaimer
Clinical practice guidelines assist clinicians by providing a framework for the evaluation and treatment of
patients. This guideline outlines the preferred approach for most patients. It is not intended to replace a
clinician’s judgment or to establish a protocol for all patients. It is understood that some patients will not fit
the clinical condition contemplated by a guideline and that a guideline will rarely establish the only
appropriate approach to a problem.

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10
Appendix A. Evidence Grading Scheme
Figure 1. GRADE Methodology adapted by UW Health
1



GRADE Ranking of Evidence
High We are confident that the effect in the study reflects the actual effect.
Moderate
We are quite confident that the effect in the study is close to the true effect, but it
is also possible it is substantially different.
Low The true effect may differ significantly from the estimate.
Very Low The true effect is likely to be substantially different from the estimated effect.

GRADE Ratings for Recommendations For or Against Practice
Strong
The net benefit of the treatment is clear, patient values and circumstances
are unlikely to affect the decision.
Weak/conditional
Recommendation may be conditional upon patient values and
preferences, the resources available, or the setting in which the
intervention will be implemented.
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11
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Contact: Lee Vermeulen, CCKM@uwhealth.org Last Revised: 06/2017CCKM@uwhealth.org