Treating your chronic hep B patients.

Once diagnosed, chronic hep B (CHB) patients should be evaluated to determine the phase of infection and eligibility for treatment, according to accepted guidelines.^1-3

Initial CHB patient pre-treatment evaluation^1-4

The initial evaluation should include a thorough history and physical examination, followed by laboratory tests.

History and physical examination to assess:

Risk factors for viral hepatitis
Family history of HCC
Route of transmission
History of alcohol use
Presence of comorbid diseases
Duration of infection
Risk factors for HIV coinfection

Laboratory tests may include:

Serial testing for HBV DNA and ALT
HBeAg and anti-HBe
LFTs, including CBC with platelets, PLT, HFP, and PT
HCC screening: MRI (preferred), computed tomography, AFP, or ultrasound
Urinalysis
HBV genotype
Tests for antibodies to HAV, HCV, HDV, and HIV
Transient elastography or liver biopsy^a

ALT=alanine aminotransferase; Anti-HBe=antibody to HBeAg; CBC=complete blood count; HBeAg=hepatitis B e-antigen; HBsAg=hepatitis B surface antigen; HBV=hepatitis B virus; HBV DNA=hepatitis B virus deoxyribonucleic acid; HCC=hepatocellular carcinoma; HCV=hepatitis C virus; HDV=hepatitis D virus; HIV=human immunodeficiency virus; HFP=hepatic function panel; LFT=liver function tests; PLT=platelet; PT=prothrombin time

^aLiver biopsy is optional for patients indicated for treatment, but may be helpful in those with normal ALT and >35-40 years of age.⁴

Identifying the phase of HBV infection

Chronic hep B follows a variable clinical course–not all patients will go through each phase (including resolution).⁴

Regular testing, including HBeAg status, ALT, and HBV DNA will help identify the patient's current phase of infection and determine the required course of action^1,4

While treatment is not always indicated, patients will require lifelong monitoring⁵

Natural course of HBV infection

Figure adapted from Tong MJ, et al.⁶
Terminology in parenthesis is from the EASL 2017 guidelines.³

EASL=European assocation for the study of the Liver; HBsAG=hepatitis B surface antigen.

CHB Treatment goals

Decrease morbidity and mortalityrelated to CHB²

Prevent progressionof CHB to cirrhosis, end-stage liver disease and HCC⁶

“Antiviral agents active against HBV are available, and haves been shown to suppress HBV replication, prevent progression to cirrhosis, and reduce the risk of HCC and liver-related deaths.”
-WHO guidelines⁷

Overview of AASLD, AATA, EASL, and USTA CHB treatment guidelines and algorithms

Given the dynamic nature of chronic hepatitis B infection, ongoing monitoring of HBV DNA and ALT levels is important to characterize the phase of infection and to ensure that treatment is initiated when necessary.

Across current chronic hepatitis B guidelines, treatment initiation is guided by HBV DNA and ALT levels and/or the presence of cirrhosis.^1,3,6

	HBV DNA (IU/mL)	ALT (U/L)
	HBeAg+
AASLD 2018¹	>20,000	≥2×ULN^b or significant liver disease^c,d
AATA 2018⁶	>2000	>ULN^b or significant liver disease^c/other risk factors^e
EASL 2017³	>2000	>ULN^band/or evidence of liver disease^c,f
	>20,000	>ULN^b

	HBV DNA (IU/mL)	ALT (U/L)
	HBeAg–
AASLD 2018¹	>2000	≥2×ULN^b or significant liver disease^c,d
AATA 2018⁶	>2000	>2×ULN^b or significant liver disease^c/other risk factors^e
EASL 2017³	>2000	>2×ULN^b or significant liver disease^c,f
	>2000	>2×ULN^b

	HBV DNA (IU/mL)	ALT (U/L)
	Cirrhosis (HBeAg±)
AASLD 2018¹	Detectable	Any
AATA 2018⁶	Detectable	Any
EASL 2017³	Detectable	Any

	HBV DNA (IU/mL)	ALT (U/L)	HBV DNA (IU/mL)	ALT (U/L)	HBV DNA (IU/mL)	ALT (U/L)
	HBeAg+		HBeAg–		Cirrhosis (HBeAg±)
AASLD 2018¹	>20,000	≥2×ULN^b or significant liver disease^c,d	>2000	≥2×ULN^b or significant liver disease^c,d	Detectable	Any
AATA 2018⁶	>2000	>ULN^b or significant liver disease^c/other risk factors^e	>2000	>2×ULN^b or significant liver disease^c/other risk factors^e	Detectable	Any
EASL 2017³	>2000	>ULN^band/or evidence of liver disease^c,f	>2000	>2×ULN^b or significant liver disease^c,f	Detectable	Any
	>20,000	>ULN^b	>2000	>2×ULN^b

AASLD=American Association for the Study of Liver Diseases; AATA=Asian American Treatment Algorithm; EASL=European Association for the Study of the Liver; ULN=upper limit of normal;

^bULN criteria for men and women, respectively: AASLD 2018: 35 U/L and 25 U/L; AATA 2018: local laboratory range; EASL 2017: ~40 U/L for both.
^cNoninvasive testing showing significant fibrosis (≥F2) or liver biopsy showing moderate/severe inflammation (A2 or A3) and/or significant fibrosis (≥F2).
^dTreatment can be considered for those >40 years of age, with a family history of cirrhosis or HCC, previous treatment history, or extrahepatic manifestations (presence of extrahepatic manifestation is an indication for treatment, independent of liver disease severity).
^eAlbumin <3.5 g/dL, platelet count <130,000/mm3, presence of basal core promoter mutation, HCC in first-degree relative, or elevated AFP in the absence of HCC.
^fHBeAg+ CHB patients with persistently high HBV DNA and normal ALT may be treated if they are >30 years old, regardless of the severity of liver histologic lesions. HBeAg+ or HBeAg− CHB patients with a family history of HCC or cirrhosis and extrahepatic manifestations can be treated even if typical treatment indications are not fulfilled. CHB patients with compensated or decompensated cirrhosis need treatment, with any detectable HBV DNA level and regardless of ALT levels.

Long-term, if not indefinite, antiviral treatment is recommended for many CHB patients^4,8

3 points to discuss with your patients about CHB treatment

Provide effective counseling and education about long-term effects of hepatitis B to help patients understand the severity of the disease
Follow up with patients to ensure they understand the importance and goals of treatment
Inform patients that treatment support programs may be available, if applicable

Interested in learning about a treatment option for your patients with chronic Hep B?Find out More

Managing chronic hepatitis B

Information for healthcare professionals

Chronic Hepatitis B Screening & Management Brochure

An overview of the importance of CHB screening and management, including recommendations to simplify management and improve care of chronic hepatitis B patients.

Download the Brochure

ICD-10 Code Finder

A select list of hepatitis B diagnosis codes.

Download the List

ACP=American College of Physicians; CDC=Centers for Disease Control and Prevention; USPSTF=U.S. Preventive Services Task Force; WHO=World Health Organization.

References:

Terrault N, Lok A, McMahon B, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67(4):1560-1599.

Terrault N, Bzowej N, Chang K, et al. AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016;63:261-283.

European Association for the Study of the Liver. EASL 2017 clinical practice guidelines on the management of hepatitis B virus infection. J Hepatol. 2017;67(2):370-398.

Martin P, Lau D, Nguyen M, et al. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: 2015 update. Clin Gastroenterol Hepatol. 2015;13(12):2071-2087.e16.

Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 2008;57:1-20.

Tong M, Pan C, Han S, et al. An expert consensus for the management of chronic hepatitis B in Asian Americans. Aliment Pharmacol Ther. 2018;47(8):1181-1200.

World Health Organization (WHO). Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. Geneva, Switzerland: WHO Press; 2015.

Papatheodoridis G, Vlachogiannakos I, Cholongitas E, et al. Discontinuation of oral antivirals in chronic hepatitis B: A systematic review. Hepatology. 2016;63:1481-149.