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Lesson 1. Hepatitis B Management:
Guidance for the Primary Care Provider

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Last Updated: December 1st, 2025

Purpose

The purpose of this document is to provide simplified, up-to-date, and readily accessible guidance for primary care medical providers and non-specialists related to the prevention, diagnosis, and management of hepatitis B virus (HBV) infection, including hepatocellular carcinoma surveillance.

About

About the HBV Primary Care Workgroup

This guidance was developed by the Hepatitis B Primary Care Workgroup, a multidisciplinary panel of national experts in the field of viral hepatitis B, including representation from primary care, hepatology, infectious diseases, public health, and community coalitions. The workgroup did not receive any outside funding for this project. For full workgroup member title information and disclosures, see the section titled HBV Primary Workgroup Members.

  • Steering Committee: Amy S. Tang, MD; Su Wang, MD, MPH; Karla Thornton, MD, MPH; H. Nina Kim, MD, MSc; David H. Spach, MD
  • Workgroup Members (listed in alphabetical order): Richard Andrews, MD, MPH; Carla S. Coffin, MD, MSc; Chari Cohen, DrPH, MPH;  Jordan Feld, MD, MPH; Jean-Jacques Kayembe, MD, MPH; Min Kim, MD; Joseph K. Lim, MD; Ronald Nahass, MD, MHCM; Thaddeus Pham, MPH; Nancy Reau, MD; Richard So, MPH, MPA; Norah A. Terrault, MD, MPH; Amy Trang, PhD, M.Ed; Carolyn Wester, MD, MPH; Nash A.K. Witten, MD; Robert J. Wong, MD, MS; Julie Yoshimachi, DNP 
  • Workgroup Support: Zinnia Dong

Collaboration with University of Washington

This guidance was produced in collaboration with the University of Washington (UW) Infectious Diseases Education & Assessment (IDEA) Program. The UW IDEA program will host the most current version of this guidance on the free Hepatitis B Online website. The Hepatitis B Online website is funded by the Centers for Disease Control and Prevention (CDC).

Suggested citation

Tang AS, Wang S, Thornton K, and HBV Primary Care Workgroup. Hepatitis B Management: Guidance for the Primary Care Provider. December 1, 2025. [https://www.hepatitisB.uw.edu/hbv-pcw/guidance]

Chronic Hepatitis B Testing and Management Algorithm

The following summarizes hepatitis B screening recommendations for adults and the subsequent management based on the hepatitis B surface antigen (HBsAg) test result.

Screening

Screen for chronic hepatitis B virus (HBV) infection in all adults aged 18 years and older,1,2 regardless of risk, with:

  • Hepatitis B surface antigen (HBsAg), and
  • Hepatitis B surface antibody (anti-HBs), and
  • Hepatitis B core antibody (anti-HBc): Total or IgG3
Footnotes
1HBV screening is recommended for all pregnant women, regardless of age and during each pregnancy, and for adults aged 18 years and older, regardless of risk (per U.S. Centers for Disease Control and Prevention recommendations).
2HBV testing is recommended for all persons with a risk of exposure, regardless of age; periodic testing is recommended for all persons susceptible to HBV infection with ongoing exposure(s) since last testing (see CDC site for full list of exposures).
3 During the typical course of chronic infection, total anti-HBc and HBsAg will persist, whereas IgM anti-HBc will disappear. IgM anti-HBc should be ordered only when acute HBV infection is a concern.
Management if HBsAg(+)

See HBV Evaluation, Counseling, Management, Treatment, and Liver Cancer Surveillance

Management if HBsAg(-)

See HBV Serology Interpretation and Management

  • If susceptible to HBV as indicated by anti-HBc(–) & anti-HBs(–), vaccinate1,2
  • If prior HBV infection as indicated by anti-HBc(+), counsel on HBV reactivation risk3
Footnotes
1The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends hepatitis B vaccination for all persons younger than 60 years of age, and adults 60 years and older with risk factors for hepatitis B or without identified risk factors but seeking protection.
2If screening and vaccination are done together, draw blood before vaccination. If vaccinated first, delay HBsAg testing by ≥4 weeks to avoid false positives. If HBsAg is positive, do not complete the vaccine series and link to care.
3 Check HBV DNA if isolated anti-HBc(+) in patients with immunosuppression to evaluate for occult hepatitis B.

Shared Management of Hepatitis B Between Primary Care and Specialty Settings

The following diagram illustrates that screening, diagnosis, treatment of HBV, and treatment of complications of HBV should involve primary care providers and specialists. Some aspects of care can be managed by either group and by shared management. 

Table 1.
Primary Care or Non-Specialist Care
  • HBV Screening
  • HBV and HAV vaccination
  • Initial evaluation and counseling of HBsAg(+) patient
  • Screening for coinfection with HCV and/or HIV
  • Management of metabolic syndrome risk factors (e.g., obesity, diabetes, hyperlipidemia, hypertension)
  • HBV lab monitoring every 6 months for patients not on treatment
  • Liver cancer surveillance ultrasound and serum AFP every 6 months if indicated
Either Care Setting or Shared Management
  • Initiation and monitoring of HBV treatment (including patients with compensated cirrhosis)
  • Monitoring for planned HBV treatment withdrawal
  • Screening for coinfection with HDV
  • Perinatal HBV management
  • Referral for HBV therapeutic clinical trials
Specialist Care (GI/Hepatology/ID)
  • Decompensated cirrhosis evaluation 
  • Management of coinfection with HDV
  • Concern of antiviral resistance with persistent or increased viremia on treatment
  • Persistent elevation of liver enzymes despite low HBV DNA levels and lack of other identifiable cause
  • Liver lesion on CT or MRI is suspicious for liver cancer
  • Liver cancer evaluation and treatment with Hepatology/Surgery/Oncology
Abbreviations
AFP = alpha-fetoprotein
CT = computed tomography
GI = gastroenterology
HAV = hepatitis A virus
HBV = hepatitis B virus
HCV = hepatitis C virus
HDV = hepatitis D virus
HIV = human immunodeficiency virus
ID = infectious diseases
MRI = magnetic resonance imaging

Hepatitis B Virus (HBV) Serology Interpretation and Management

Activity: HBV Serology Interpretation and Management

HBV Serology Interpretation and Management

HBsAg
Anti-HBc (Total or IgG)
Anti-HBs
Result
Results will be displayed here when all selections have been made.
Interpretation
 
Management
 
 

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Initial Evaluation of the HBsAg(+) Patient

Table 2.

Initial Evaluation of the HBsAg(+) Patient

History/Examination
Routine Laboratory Tests
• AST/ALT
• Total bilirubin
• Alkaline phosphatase
• Albumin
• Creatinine
Serology/Virology
Note 1: If HCV antibody positive/reactive, check HCV RNA for current HCV infection; consider ordering HCV RNA instead of anti-HCV if history of prior HCV treatment or possible exposure within past 6 months.
Note 2: If HDV antibody positive, check HDV RNA to evaluate for active coinfection and refer to liver specialist for treatment if detectable.
Imaging/Staging Studies
Note 3: AST to Platelet Ratio index (APRI) and Fibrosis-4 (FIB-4) scores can be calculated using platelet count and AST and ALT from routine labs. Calculators with score interpretation are available. See Hepatitis B Online APRI calculator and FIB-4 calculator. FibroSure and FibroTest are commercially available blood tests that can be ordered as well.
Footnotes
1 If HCV antibody positive/reactive, check HCV RNA for current HCV infection; consider ordering HCV RNA instead of anti-HCV if history of prior HCV treatment or possible exposure within past 6 months.
2 If HDV antibody positive, check HDV RNA to evaluate for active coinfection and refer to liver specialist for treatment if detectable.
3 AST to Platelet Ratio index (APRI) and Fibrosis-4 (FIB-4) scores can be calculated using platelet count and AST and ALT from routine labs. Calculators with score interpretation are available. See Hepatitis B Online APRI calculator and FIB-4 calculator. FibroSure and FibroTest are commercially available blood tests that can be ordered as well.
Abbreviations
Ag/Ab = antigen/antibody
ALT = alanine aminotransferase
anti-HBe = antibody to hepatitis B e antigen
APRI = AST to Platelet Ratio Index
AST = aspartate aminotransferase
HAV = hepatitis A virus
HBeAg = hepatitis B e antigen
HCV = hepatitis C virus
HDV = hepatitis D virus
HIV = human immunodeficiency virus
IgG = immunoglobulin G
INR = international normalized ratio

Counseling of the HBsAg(+) Patient

  1. Provide education on HBV transmission prevention, including safe practices and the importance of notifying close contacts, using non-stigmatizing language.
    Table 3.

    Persons with chronic HBV:

     Should:
    • Verify that sexual contacts, household contacts, family members, or injection partners are screened and vaccinated (if susceptible)
    • Cover open cuts and scratches
    • Clean blood spills with diluted (1:10) bleach
    • Use condoms to prevent HBV transmission during sexual intercourse with partners who are susceptible to HBV infection
     Should feel free to safely:
    • Participate in all daily and community activities, including contact sports
    • Share food and utensils, or kiss others
    • Pursue pregnancy (see Perinatal HBV Management section)
    • Pursue educational or career opportunities without limitations, including work as a health care professional
     Should NOT:
    • Share toothbrushes, razors, nail clippers, or earrings with those susceptible/nonimmune to HBV
    • Share injection equipment
    • Share glucose testing equipment
    • Donate blood, organs, or sperm
  2. Co-develop a plan for follow-up care. Patients will need regular (approximately every 6 months) follow-up and monitoring for disease progression.
  3. Educate patients on the potential long-term complications of chronic HBV infection, such as cirrhosis, hepatocellular carcinoma (HCC), and the risk of hepatitis D virus (HDV) coinfection. 
  4. Encourage patients to inform all current and future medical providers of their HBsAg-positive status, particularly before starting treatment for cancer or autoimmune conditions (e.g., rheumatoid arthritis).
  5. Counsel to limit alcohol consumption to reduce liver damage, and to avoid consumption if cirrhosis present.
  6. Encourage patients to inform their medical provider about any use of herbal or over-the-counter medications to avoid potential liver toxicity.
  7. Advise to optimize body weight and address metabolic complications, including control of diabetes and dyslipidemia (to prevent concurrent development of metabolic syndrome and fatty liver).
  8. Emphasize that with proper monitoring and care, most people with hepatitis B can live long, healthy, and normal lives.

Management of the HBsAg(+) Patient

The following summarizes treatment indications and laboratory monitoring for persons ≥12 years of age with chronic hepatitis B (HBsAg+).

Table 4.
TREATMENT INDICATIONS
For Adolescents (age ≥12 years) and Adults with Chronic Hepatitis B
In principle, all HBsAg+ individuals with viremia are candidates for treatment. Factors to consider are fibrosis stage, HBV DNA, ALT, risk of disease progression and hepatocellular carcinoma (HCC), and patient preference.
1.  Significant fibrosis or cirrhosis (≥F2; elastography >7 kPa or APRI >0.51)
       and
     Detectable HBV DNA
       -OR-
 2.  HBV DNA >2,000 IU/mL
       and 
     Elevated ALT2 or Family history of HCC
       -OR-
 3.  Any of the following conditions:
  • Immunosuppression3
  • Viral coinfections (e.g., HIV, HDV, HCV treatment4)
  • HBV transmission risk factors5
  • Extrahepatic manifestations of HBV6
       -OR-
 4.  Patient preference for treatment over monitoring-only7
RECOMMENDED LAB MONITORING

For all with chronic HBV (patients on treatment and not on treatment): 

  • HBV DNA, ALT every 6 months (may vary from 3 to 12 months)8
  •  AST, platelet count, or elastography every 1 to 3 years

If HBV DNA undetectable:

  • HBsAg once yearly for HBsAg loss
Footnotes
1 If APRI >0.5, discuss treatment and either initiate treatment or get transient elastography to confirm need for treatment, depending on patient preference and resource availability.
2 Elevated ALT defined as >25 U/L in females and >35 U/L in males that is persistent for at least 3 to 6 months.
3 Refer to AGA Clinical Practice Guideline on the Prevention and Treatment of HBV Reactivation for list of immunosuppressive medications posing moderate to high risk for HBV reactivation.
4 HBV antiviral treatment is recommended during HCV direct-acting antiviral (DAA) treatment to prevent HBV reactivation.
5 Transmission factors include pregnancy with HBV DNA >200,000 IU/mL, sexual or close contact with someone who is nonimmune or unknown HBV status or immunocompromised, and health care worker doing Society for Healthcare Epidemiology of America (SHEA) category 3 exposure-prone procedures (e.g., procedures with a higher likelihood of healthcare personnel-to-patient bloodborne pathogen transmission, specifically when the health care worker’s hands, even when gloved, may come into contact with sharp instruments, needle tips, or bone spicules within a poorly visualized or confined anatomical site).
6 Extrahepatic manifestations of HBV include glomerulonephritis, polyarteritis nodosa, serum sickness-like syndrome, vasculitis.
7 Patient prefers long-term treatment over monitoring-only approach after discussion of risk and benefits, including risk of post-treatment flare if treatment is prematurely discontinued.
8 Depending on factors such as recent treatment initiation, liver enzymes, and viral load, patients may need to be monitored more or less frequently.
Abbreviations
ALT = alanine aminotransferase
APRI = AST to Platelet Ratio Index
AST = aspartate aminotransferase
HBsAg = hepatitis B surface antigen
HCC = hepatocellular cancer
HCV = hepatitis C virus
HDV = hepatitis D virus

Preferred Antiviral Treatment of the HBsAg(+) Patient

Preferred Medications for Treatment of Chronic Hepatitis B

The following table summarizes the key characteristics for the three preferred oral antiviral medications used to treat adults with chronic hepatitis B. 

Table 5.
Entecavir (ETV)*
Baraclude
Note *: Available as generic medications
Adult dose
  • Standard: 0.5 mg by mouth daily
  • Take 2 hours before or after food
  • Decompensated liver disease 2 or lamivudine-resistant or lamivudine-experienced individuals: 1 mg by mouth daily
    Note 2: Decompensated liver disease is defined as Child-Turcotte-Pugh (CTP) ≥7 (see Hepatitis B Online CTP calculator).
Pregnancy category1
Note 1: In 2015, the US FDA replaced the pregnancy risk designation by letters A, B, C, D, and X with more specific language on pregnancy and lactation. This new labeling is being phased in gradually and, to date, only tenofovir alafenamide includes these additional data.
  • Formerly FDA category C
  • Limited pregnancy exposure, pregnancy exposure registry available
  • Insufficient human data to assess risk of major birth defects
  • No adverse effects observed in animal studies
Side effects
  • Headache, fatigue, dizziness, nausea reported in ≤3%
  • Post-marketing surveillance includes rare reports of:
    • lactic acidosis
    • severe hepatomegaly
Monitoring on treatment
  • Adjust dose with CrCl <50 mL/min
  • Lactic acid levels if clinical concern
Tenofovir DF (TDF)*
Viread
Note *: Available as generic medications
Adult dose
  • 300 mg by mouth daily
  • Take without regard to food
Pregnancy category1
Note 1: In 2015, the US FDA replaced the pregnancy risk designation by letters A, B, C, D, and X with more specific language on pregnancy and lactation. This new labeling is being phased in gradually and, to date, only tenofovir alafenamide includes these additional data.
  • Formerly FDA category B
  • Pregnancy exposure registry available
  • Extensive data from pregnant women with HIV or HBV infections indicate no increase in pregnancy complications or major birth defects
Side effects
  • Nausea (9%)
  • Post-marketing surveillance includes infrequent reports of:
    • nephropathy
    • Fanconi syndrome
    • osteomalacia
    • lactic acidosis
Monitoring on treatment
  • Adjust dose with CrCl <50 mL/min
  • Serum creatinine at baseline; if at risk for renal impairment, serum creatinine and phosphorus, and urine glucose and protein at least annually
  • Consider bone density study at baseline and during treatment in persons with history of fracture or risks for osteopenia
  • Lactic acid levels if clinical concern
Tenofovir alafenamide (TAF)
Vemlidy
Adult dose
  • 25 mg by mouth daily
  • Take with food
Pregnancy category1
Note 1: In 2015, the US FDA replaced the pregnancy risk designation by letters A, B, C, D, and X with more specific language on pregnancy and lactation. This new labeling is being phased in gradually and, to date, only tenofovir alafenamide includes these additional data.
  • Pregnancy exposure registry available3
  • First-trimester exposure to TAF is not associated with increased risk of congenital anomalies3
  • No adverse effects observed in animal studies
Note 3: Pregnancy data for TAF from the antiretroviral pregnancy registry: https://www.apregistry.com/HCP.aspx
Side effects
  • Headache (12%)
  • Lactic acidosis/severe hepatomegaly with steatosis is a warning for TAF due to rare reports with use of TDF
Monitoring on treatment
  • Avoid with CrCl <15 mL/min if not receiving hemodialysis
  • Dose after hemodialysis in those on hemodialysis
  • If at risk for renal impairment, serum creatinine and phosphorus, and urine glucose and protein, as clinically indicated.
  • Lactic acid levels if clinical concern
Footnotes
* Available as generic medications
1 In 2015, the US FDA replaced the pregnancy risk designation by letters A, B, C, D, and X with more specific language on pregnancy and lactation. This new labeling is being phased in gradually and, to date, only tenofovir alafenamide includes these additional data.
2 Decompensated liver disease is defined as Child-Turcotte-Pugh (CTP) ≥7 (see Hepatitis B Online CTP calculator).
3 Pregnancy data for TAF from the antiretroviral pregnancy registry: https://www.apregistry.com/HCP.aspx
Abbreviations
CrCl = creatinine clearance

Liver Cancer Surveillance

Indications for Liver Cancer (Hepatocellular Carcinoma) Surveillance

Persons with chronic HBV at increased risk for hepatocellular carcinoma (HCC) who require routine surveillance, including after observed HBsAg loss:

  • All persons with cirrhosis
  • The following populations, even in the absence of cirrhosis:
    • Men over 40 years of age1
    • Women over 50 years of age1
    • Persons with a family history of HCC
    • Persons with hepatitis D virus or HIV2 coinfection

Recommended HCC Surveillance Method

HCC surveillance should be performed in the primary care setting with liver ultrasound with serum alpha-fetoprotein (AFP)3 every 6 months. More frequent monitoring or other imaging modalities, such as computed tomography (CT) or magnetic resonance imaging (MRI), with and without contrast, may be indicated to further evaluate new liver lesions.

When to Stop HCC surveillance?

HCC surveillance can be stopped in persons with limited life expectancy or who would not tolerate treatment for HCC, if found. Persons with observed HBsAg loss before age 50 years of age and without cirrhosis are at low risk for HCC and may stop HCC surveillance.

Footnotes
1Consider earlier HCC surveillance (younger than standard age cutoffs) for persons from Africa (e.g., as early as 30 years of age, given median age at HCC diagnosis of 46 years of age), persons with genotypes or viral features linked to early HCC, persons with high HCC risk scores (e.g., REACH-B or PAGE-B, and based on patient preferences for surveillance). AASLD recommends HCC surveillance in men >40 years of age from endemic regions and women >50 years of age from endemic regions.
2AASLD recommends HCC surveillance in male-born persons >18 years of age and female-born persons >40 years of age with HBV-HIV coinfection.
3 Wait at least 6 months after pregnancy before using AFP for HCC surveillance.

Perinatal HBV Management

Table 6.
Screening for Hepatitis B In Pregnant Women

All women should undergo hepatitis B screening during each pregnancy.1 Screening should consist of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs), and hepatitis B core antibody (HBcAb). The following summarizes the approach to prevention of perinatal hepatitis B transmission based on the HBsAg status of the mother.

Note 1: All pregnant women should be screened for HBV (with HBsAg at minimum) during each pregnancy, regardless of prior HBV screening results. For complete HBV profile, add anti-HBs to determine immunity and anti-HBc IgG or total for evidence of prior infection.
Management if Mother HBsAg (+)

Initial Evaluation and Counseling

Evaluate and counsel all pregnant women with a new hepatitis B diagnosis2

Note 2: All HBsAg(+) mothers should be educated on the importance of regular follow-up during and after the pregnancy so that appropriate HBV monitoring can occur, especially since the postpartum period is a time of increased risk for hepatitis B flares.
  • Perform initial hepatitis B evaluation
  • Screen all household and sexual contacts for HBV
  • Provide counseling for HBV transmission risks

Evaluate for HBV Treatment

  • If treatment indicated for active HBV, start TDF or TAF and continue until stopping criteria met3
    Note 3: If an HBsAg(+) woman is taking entecavir when she becomes pregnant, the antiviral regimen should immediately be switched to tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) if she is not already taking one of these medications.
  • If not on HBV treatment, recheck HBV DNA before 28 weeks’ gestation age to determine HBV mother-to-child transmission risk4
    Note 4: If HBV DNA <200,000 IU/mL in the first trimester, consider retesting in the second trimester as viral load may rise.
    • HBV DNA ≤200,000 IU/mL: low risk for HBV mother-to-child transmission; no HBV antiviral therapy required
    • HBV DNA >200,000 IU/mL: high risk for HBV mother-to-child transmission; start TDF or TAF at gestational week 28 or earlier
      • Stop TDF or TAF at time of birth and monitor for ALT flares at least every 3 months for 6 months 

Infant Management

ALL infants of HBsAg(+) women should:

  • Receive birth dose HBV vaccine and HBIG within 12 hours of birth
  • Complete HBV vaccine series on schedule5
    Note 5: For infants weighing less than 2,000 grams, the birth dose does not count toward the vaccine series, and the infant should receive another HBV vaccine one month after birth.

  • Receive a post-vaccination serology test at 9 to 12 months of age with HBsAg and anti-HBs to assess for mother-to-child transmission and confirm immunity

HBV and Breastfeeding

All HBsAg(+) mothers, including those on TDF or TAF, should be educated on the value and safety of breastfeeding and that HBV is not transmitted through breastmilk. Breastfeeding mothers with cracked nipples should practice proper nipple care and be informed that infant receipt of HBV vaccination and HBIG will protect against HBV acquisition from such blood exposures.

Management if Mother HBsAg (-)

Evaluate Immunity

Interpret HBV serology and provide appropriate next step:

  • If HBV susceptible and at high risk for HBV infection, vaccinate during pregnancy6
    Note 6: Engerix-B, Recombivax-HB, Heplisav-B, and Twinrix are safe to give at any time during pregnancy; however Heplisav-B and Twinrix are approved for use among those aged 18 years and older.

Infant Management

ALL infants of HBsAg(-) women should:

  • Receive birth dose HBV vaccine within 24 hours of birth
  • Complete HBV vaccine series on schedule5
Note 5: For infants weighing less than 2,000 grams, the birth dose does not count toward the vaccine series, and the infant should receive another HBV vaccine one month after birth.
Footnotes
1 All pregnant women should be screened for HBV (with HBsAg at minimum) during each pregnancy, regardless of prior HBV screening results. For complete HBV profile, add anti-HBs to determine immunity and anti-HBc IgG or total for evidence of prior infection.
2 All HBsAg(+) mothers should be educated on the importance of regular follow-up during and after the pregnancy so that appropriate HBV monitoring can occur, especially since the postpartum period is a time of increased risk for hepatitis B flares.
3 If an HBsAg(+) woman is taking entecavir when she becomes pregnant, the antiviral regimen should immediately be switched to tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) if she is not already taking one of these medications.
4 If HBV DNA <200,000 IU/mL in the first trimester, consider retesting in the second trimester as viral load may rise.
5 For infants weighing less than 2,000 grams, the birth dose does not count toward the vaccine series, and the infant should receive another HBV vaccine one month after birth.
6 Engerix-B, Recombivax-HB, Heplisav-B, and Twinrix are safe to give at any time during pregnancy; however Heplisav-B and Twinrix are approved for use among those aged 18 years and older.
Abbreviations
MTCT = mother-to-child transmission
TDF = tenofovir disoproxil fumarate
TAF = tenofovir alafenamide
HBIG = hepatitis B immune globulin

HBV Primary Care Workgroup Members*

Note *: Committee participation in the HBV Primary Care Workgroup does not constitute organizational endorsement of the recommendations or conclusions.

HEPATOLOGY

Carla S. Coffin, MD, MSc
Professor of Medicine
President, Canadian Association for the Study of the Liver
Director, Viral Hepatitis Clinic
Cumming School of Medicine, Snyder Institute,
University of Calgary Alberta, Canada

Jordan Feld, MD, MPH
Professor of Medicine
Director, Hepatology
Toronto Centre for Liver Disease, Toronto General Hospital,
University of Toronto

Joseph K. Lim, MD
Professor of Medicine
Director, Clinical Hepatology
Vice-Chief, Section of Digestive Diseases
Yale University School of Medicine

Nancy Reau, MD
Professor of Medicine
Richard B. Capps Chair of Hepatology
Chief, Section of Hepatology
Rush University Medical Center

Norah A. Terrault, MD, MPH
Professor of Medicine
Chief, Division of Gastroenterology and Hepatology
Keck School of Medicine, University of Southern California
AASLD Hepatitis B Guideline Co-Chair

Robert J. Wong, MD, MS
Clinical Associate Professor
Division of Gastroenterology and Hepatology
Stanford University School of Medicine
 

INFECTIOUS DISEASES

H. Nina Kim, MD, MSc
Professor of Medicine
Department of Medicine, Division of Allergy and Infectious Disease
University of Washington

Ronald Nahass, MD, MHCM
Director of Medical Research
President-elect, Infectious Diseases Society of America
ID Care

David H. Spach, MD
Professor Medicine
Division of Allergy and Infectious Diseases
University of Washington

Karla Thornton, MD, MPH
Professor, Division of Infectious Diseases
Interim Executive Director, Project ECHO
University of New Mexico Health Science Center
 

PRIMARY CARE

Richard Andrews, MD, MPH
Medical Director
El Dorado Methadone Clinics, Brownsville / Pharr, TX
President, Houston Viral Hepatitis Task Force

Amy S. Tang, MD
Director of Viral Hepatitis and TB Programs
North East Medical Services, San Francisco, CA

Su Wang, MD, MPH
Medical Director, Center for Asian Health
Cooperman Barnabas Medical Center, Florham, NJ

Nash A.K. Witten, MD
Assistant Clinical Professor
Department of Family Medicine and Community Health
University of Hawaii John A. Burns School of Medicine, Aiea, HI

Julie Yoshimachi, DNP
Director of Hepatitis B Program
Charles B. Wang Community Health Center, New York, NY
 

PUBLIC HEALTH

Chari Cohen, DrPH, MPH
President Hepatitis B Foundation
Professor, Baruch S. Blumberg Institute

Jean-Jacques Kayembe, MD, MPH
Founder and Executive Director
Congolese United Foundation Hepatitis Coalition of Washington
Vice-Chair, Immunization Action Coalition of Washington

Min Kim, MD
Medical Officer
Division of Viral Hepatitis
Centers for Disease Control and Prevention

Thaddeus Pham, MPH
Viral Hepatitis Prevention Coordinator
Hawaiʻiʻ Department of Health
Co-Director of Hep Free Hawaiʻi

Richard So, MPH, MPA
Executive Director
Hep B Free

Amy Trang, PhD, M.Ed
Administrator
National Taskforce on Hepatitis B

Carolyn Wester, MD, MPH
Director, Division of Viral Hepatitis
Centers for Disease Control and Prevention
 

Additional Workgroup Support from:
Zinnia Dong
Viral Hepatitis and TB Program Associate
North East Medical Services, San Francisco, CA

Disclosure Information

Workgroup Members with No Disclosures

The following workgroup members had no disclosures: Jean-Jacques Kayembe, MD, MPH; H. Nina Kim, MD, MSc; Min Kim, MD; Thaddeus Pham, MPH; David H. Spach, MD; Karla Thornton, MD, MPH; Carolyn Wester, MD, MPH; and Nash A.K. Witten, MD.

Workgroup Members with Disclosures

The following workgroup members had disclosures as outlined in the table below (Figure 1).

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References

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  • Perrillo RP, Gish R, Falck-Ytter YT. American Gastroenterological Association Institute technical review on prevention and treatment of hepatitis B virus reactivation during immunosuppressive drug therapy. Gastroenterology. 2015;148:221-244.e3.
  • Schillie S, Harris A, Link-Gelles R, Romero J, Ward J, Nelson N. Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant. MMWR Morb Mortal Wkly Rep. 2018;67:455-8.
  • Schillie S, Vellozzi C, Reingold A, et al. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018;67:1-31.
  • Tang LSY, Covert E, Wilson E, Kottilil S. Chronic Hepatitis B Infection: A Review. JAMA. 2018;319:1802-13.
  • Terrault NA, Bzowej NH, Chang KM, Hwang JP, Jonas MM, Murad MH. AASLD guidelines for treatment of chronic hepatitis B. Hepatology. 2016;63:261-83.
  • Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018;67:1560-99.
  • US Preventive Services Task Force, Owens DK, Davidson KW, et al. Screening for Hepatitis B Virus Infection in Pregnant Women: US Preventive Services Task Force Reaffirmation Recommendation Statement. JAMA. 2019;322:349-54.
  • Yang JD, Mohamed EA, Aziz AO, et al. Characteristics, management, and outcomes of patients with hepatocellular carcinoma in Africa: a multicountry observational study from the Africa Liver Cancer Consortium. Lancet Gastroenterol Hepatol. 2017;2:103-11.

Figures

Figure 1. Disclosures
HBV DNA
Animation: HBV DNA
Hepatitis B Surface Antigen (HBsAg)
Animation: Hepatitis B Surface Antigen (HBsAg)
Total Antibody to Hepatitis B Core Antigen (Total anti-HBc)
Animation: Total Antibody to Hepatitis B Core Antigen (Total anti-HBc)
Hepatitis B e Antigen (HBeAg)
Animation: Hepatitis B e Antigen (HBeAg)
IgM Antibody to Hepatitis B Core Antigen (IgM Anti-HBc)
Animation: IgM Antibody to Hepatitis B Core Antigen (IgM Anti-HBc)
Antibody to Hepatitis B Surface Antigen (Anti-HBs)
Animation: Antibody to Hepatitis B Surface Antigen (Anti-HBs)
Antibody to Hepatitis B e Antigen (Anti-HBe)
Animation: Antibody to Hepatitis B e Antigen (Anti-HBe)

Tables

Table 1.
Primary Care or Non-Specialist Care
  • HBV Screening
  • HBV and HAV vaccination
  • Initial evaluation and counseling of HBsAg(+) patient
  • Screening for coinfection with HCV and/or HIV
  • Management of metabolic syndrome risk factors (e.g., obesity, diabetes, hyperlipidemia, hypertension)
  • HBV lab monitoring every 6 months for patients not on treatment
  • Liver cancer surveillance ultrasound and serum AFP every 6 months if indicated
Either Care Setting or Shared Management
  • Initiation and monitoring of HBV treatment (including patients with compensated cirrhosis)
  • Monitoring for planned HBV treatment withdrawal
  • Screening for coinfection with HDV
  • Perinatal HBV management
  • Referral for HBV therapeutic clinical trials
Specialist Care (GI/Hepatology/ID)
  • Decompensated cirrhosis evaluation 
  • Management of coinfection with HDV
  • Concern of antiviral resistance with persistent or increased viremia on treatment
  • Persistent elevation of liver enzymes despite low HBV DNA levels and lack of other identifiable cause
  • Liver lesion on CT or MRI is suspicious for liver cancer
  • Liver cancer evaluation and treatment with Hepatology/Surgery/Oncology
Abbreviations
AFP = alpha-fetoprotein
CT = computed tomography
GI = gastroenterology
HAV = hepatitis A virus
HBV = hepatitis B virus
HCV = hepatitis C virus
HDV = hepatitis D virus
HIV = human immunodeficiency virus
ID = infectious diseases
MRI = magnetic resonance imaging
Table 2.

Initial Evaluation of the HBsAg(+) Patient

History/Examination
Routine Laboratory Tests
• AST/ALT
• Total bilirubin
• Alkaline phosphatase
• Albumin
• Creatinine
Serology/Virology
Note 1: If HCV antibody positive/reactive, check HCV RNA for current HCV infection; consider ordering HCV RNA instead of anti-HCV if history of prior HCV treatment or possible exposure within past 6 months.
Note 2: If HDV antibody positive, check HDV RNA to evaluate for active coinfection and refer to liver specialist for treatment if detectable.
Imaging/Staging Studies
Note 3: AST to Platelet Ratio index (APRI) and Fibrosis-4 (FIB-4) scores can be calculated using platelet count and AST and ALT from routine labs. Calculators with score interpretation are available. See Hepatitis B Online APRI calculator and FIB-4 calculator. FibroSure and FibroTest are commercially available blood tests that can be ordered as well.
Footnotes
1 If HCV antibody positive/reactive, check HCV RNA for current HCV infection; consider ordering HCV RNA instead of anti-HCV if history of prior HCV treatment or possible exposure within past 6 months.
2 If HDV antibody positive, check HDV RNA to evaluate for active coinfection and refer to liver specialist for treatment if detectable.
3 AST to Platelet Ratio index (APRI) and Fibrosis-4 (FIB-4) scores can be calculated using platelet count and AST and ALT from routine labs. Calculators with score interpretation are available. See Hepatitis B Online APRI calculator and FIB-4 calculator. FibroSure and FibroTest are commercially available blood tests that can be ordered as well.
Abbreviations
Ag/Ab = antigen/antibody
ALT = alanine aminotransferase
anti-HBe = antibody to hepatitis B e antigen
APRI = AST to Platelet Ratio Index
AST = aspartate aminotransferase
HAV = hepatitis A virus
HBeAg = hepatitis B e antigen
HCV = hepatitis C virus
HDV = hepatitis D virus
HIV = human immunodeficiency virus
IgG = immunoglobulin G
INR = international normalized ratio
Table 3.

Persons with chronic HBV:

 Should:
  • Verify that sexual contacts, household contacts, family members, or injection partners are screened and vaccinated (if susceptible)
  • Cover open cuts and scratches
  • Clean blood spills with diluted (1:10) bleach
  • Use condoms to prevent HBV transmission during sexual intercourse with partners who are susceptible to HBV infection
 Should feel free to safely:
  • Participate in all daily and community activities, including contact sports
  • Share food and utensils, or kiss others
  • Pursue pregnancy (see Perinatal HBV Management section)
  • Pursue educational or career opportunities without limitations, including work as a health care professional
 Should NOT:
  • Share toothbrushes, razors, nail clippers, or earrings with those susceptible/nonimmune to HBV
  • Share injection equipment
  • Share glucose testing equipment
  • Donate blood, organs, or sperm
Table 4.
TREATMENT INDICATIONS
For Adolescents (age ≥12 years) and Adults with Chronic Hepatitis B
In principle, all HBsAg+ individuals with viremia are candidates for treatment. Factors to consider are fibrosis stage, HBV DNA, ALT, risk of disease progression and hepatocellular carcinoma (HCC), and patient preference.
1.  Significant fibrosis or cirrhosis (≥F2; elastography >7 kPa or APRI >0.51)
       and
     Detectable HBV DNA
       -OR-
 2.  HBV DNA >2,000 IU/mL
       and 
     Elevated ALT2 or Family history of HCC
       -OR-
 3.  Any of the following conditions:
  • Immunosuppression3
  • Viral coinfections (e.g., HIV, HDV, HCV treatment4)
  • HBV transmission risk factors5
  • Extrahepatic manifestations of HBV6
       -OR-
 4.  Patient preference for treatment over monitoring-only7
RECOMMENDED LAB MONITORING

For all with chronic HBV (patients on treatment and not on treatment): 

  • HBV DNA, ALT every 6 months (may vary from 3 to 12 months)8
  •  AST, platelet count, or elastography every 1 to 3 years

If HBV DNA undetectable:

  • HBsAg once yearly for HBsAg loss
Footnotes
1 If APRI >0.5, discuss treatment and either initiate treatment or get transient elastography to confirm need for treatment, depending on patient preference and resource availability.
2 Elevated ALT defined as >25 U/L in females and >35 U/L in males that is persistent for at least 3 to 6 months.
3 Refer to AGA Clinical Practice Guideline on the Prevention and Treatment of HBV Reactivation for list of immunosuppressive medications posing moderate to high risk for HBV reactivation.
4 HBV antiviral treatment is recommended during HCV direct-acting antiviral (DAA) treatment to prevent HBV reactivation.
5 Transmission factors include pregnancy with HBV DNA >200,000 IU/mL, sexual or close contact with someone who is nonimmune or unknown HBV status or immunocompromised, and health care worker doing Society for Healthcare Epidemiology of America (SHEA) category 3 exposure-prone procedures (e.g., procedures with a higher likelihood of healthcare personnel-to-patient bloodborne pathogen transmission, specifically when the health care worker’s hands, even when gloved, may come into contact with sharp instruments, needle tips, or bone spicules within a poorly visualized or confined anatomical site).
6 Extrahepatic manifestations of HBV include glomerulonephritis, polyarteritis nodosa, serum sickness-like syndrome, vasculitis.
7 Patient prefers long-term treatment over monitoring-only approach after discussion of risk and benefits, including risk of post-treatment flare if treatment is prematurely discontinued.
8 Depending on factors such as recent treatment initiation, liver enzymes, and viral load, patients may need to be monitored more or less frequently.
Abbreviations
ALT = alanine aminotransferase
APRI = AST to Platelet Ratio Index
AST = aspartate aminotransferase
HBsAg = hepatitis B surface antigen
HCC = hepatocellular cancer
HCV = hepatitis C virus
HDV = hepatitis D virus
Table 5.
Entecavir (ETV)*
Baraclude
Note *: Available as generic medications
Adult dose
  • Standard: 0.5 mg by mouth daily
  • Take 2 hours before or after food
  • Decompensated liver disease 2 or lamivudine-resistant or lamivudine-experienced individuals: 1 mg by mouth daily
    Note 2: Decompensated liver disease is defined as Child-Turcotte-Pugh (CTP) ≥7 (see Hepatitis B Online CTP calculator).
Pregnancy category1
Note 1: In 2015, the US FDA replaced the pregnancy risk designation by letters A, B, C, D, and X with more specific language on pregnancy and lactation. This new labeling is being phased in gradually and, to date, only tenofovir alafenamide includes these additional data.
  • Formerly FDA category C
  • Limited pregnancy exposure, pregnancy exposure registry available
  • Insufficient human data to assess risk of major birth defects
  • No adverse effects observed in animal studies
Side effects
  • Headache, fatigue, dizziness, nausea reported in ≤3%
  • Post-marketing surveillance includes rare reports of:
    • lactic acidosis
    • severe hepatomegaly
Monitoring on treatment
  • Adjust dose with CrCl <50 mL/min
  • Lactic acid levels if clinical concern
Tenofovir DF (TDF)*
Viread
Note *: Available as generic medications
Adult dose
  • 300 mg by mouth daily
  • Take without regard to food
Pregnancy category1
Note 1: In 2015, the US FDA replaced the pregnancy risk designation by letters A, B, C, D, and X with more specific language on pregnancy and lactation. This new labeling is being phased in gradually and, to date, only tenofovir alafenamide includes these additional data.
  • Formerly FDA category B
  • Pregnancy exposure registry available
  • Extensive data from pregnant women with HIV or HBV infections indicate no increase in pregnancy complications or major birth defects
Side effects
  • Nausea (9%)
  • Post-marketing surveillance includes infrequent reports of:
    • nephropathy
    • Fanconi syndrome
    • osteomalacia
    • lactic acidosis
Monitoring on treatment
  • Adjust dose with CrCl <50 mL/min
  • Serum creatinine at baseline; if at risk for renal impairment, serum creatinine and phosphorus, and urine glucose and protein at least annually
  • Consider bone density study at baseline and during treatment in persons with history of fracture or risks for osteopenia
  • Lactic acid levels if clinical concern
Tenofovir alafenamide (TAF)
Vemlidy
Adult dose
  • 25 mg by mouth daily
  • Take with food
Pregnancy category1
Note 1: In 2015, the US FDA replaced the pregnancy risk designation by letters A, B, C, D, and X with more specific language on pregnancy and lactation. This new labeling is being phased in gradually and, to date, only tenofovir alafenamide includes these additional data.
  • Pregnancy exposure registry available3
  • First-trimester exposure to TAF is not associated with increased risk of congenital anomalies3
  • No adverse effects observed in animal studies
Note 3: Pregnancy data for TAF from the antiretroviral pregnancy registry: https://www.apregistry.com/HCP.aspx
Side effects
  • Headache (12%)
  • Lactic acidosis/severe hepatomegaly with steatosis is a warning for TAF due to rare reports with use of TDF
Monitoring on treatment
  • Avoid with CrCl <15 mL/min if not receiving hemodialysis
  • Dose after hemodialysis in those on hemodialysis
  • If at risk for renal impairment, serum creatinine and phosphorus, and urine glucose and protein, as clinically indicated.
  • Lactic acid levels if clinical concern
Footnotes
* Available as generic medications
1 In 2015, the US FDA replaced the pregnancy risk designation by letters A, B, C, D, and X with more specific language on pregnancy and lactation. This new labeling is being phased in gradually and, to date, only tenofovir alafenamide includes these additional data.
2 Decompensated liver disease is defined as Child-Turcotte-Pugh (CTP) ≥7 (see Hepatitis B Online CTP calculator).
3 Pregnancy data for TAF from the antiretroviral pregnancy registry: https://www.apregistry.com/HCP.aspx
Abbreviations
CrCl = creatinine clearance
Table 6.
Screening for Hepatitis B In Pregnant Women

All women should undergo hepatitis B screening during each pregnancy.1 Screening should consist of hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs), and hepatitis B core antibody (HBcAb). The following summarizes the approach to prevention of perinatal hepatitis B transmission based on the HBsAg status of the mother.

Note 1: All pregnant women should be screened for HBV (with HBsAg at minimum) during each pregnancy, regardless of prior HBV screening results. For complete HBV profile, add anti-HBs to determine immunity and anti-HBc IgG or total for evidence of prior infection.
Management if Mother HBsAg (+)

Initial Evaluation and Counseling

Evaluate and counsel all pregnant women with a new hepatitis B diagnosis2

Note 2: All HBsAg(+) mothers should be educated on the importance of regular follow-up during and after the pregnancy so that appropriate HBV monitoring can occur, especially since the postpartum period is a time of increased risk for hepatitis B flares.
  • Perform initial hepatitis B evaluation
  • Screen all household and sexual contacts for HBV
  • Provide counseling for HBV transmission risks

Evaluate for HBV Treatment

  • If treatment indicated for active HBV, start TDF or TAF and continue until stopping criteria met3
    Note 3: If an HBsAg(+) woman is taking entecavir when she becomes pregnant, the antiviral regimen should immediately be switched to tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) if she is not already taking one of these medications.
  • If not on HBV treatment, recheck HBV DNA before 28 weeks’ gestation age to determine HBV mother-to-child transmission risk4
    Note 4: If HBV DNA <200,000 IU/mL in the first trimester, consider retesting in the second trimester as viral load may rise.
    • HBV DNA ≤200,000 IU/mL: low risk for HBV mother-to-child transmission; no HBV antiviral therapy required
    • HBV DNA >200,000 IU/mL: high risk for HBV mother-to-child transmission; start TDF or TAF at gestational week 28 or earlier
      • Stop TDF or TAF at time of birth and monitor for ALT flares at least every 3 months for 6 months 

Infant Management

ALL infants of HBsAg(+) women should:

  • Receive birth dose HBV vaccine and HBIG within 12 hours of birth
  • Complete HBV vaccine series on schedule5
    Note 5: For infants weighing less than 2,000 grams, the birth dose does not count toward the vaccine series, and the infant should receive another HBV vaccine one month after birth.

  • Receive a post-vaccination serology test at 9 to 12 months of age with HBsAg and anti-HBs to assess for mother-to-child transmission and confirm immunity

HBV and Breastfeeding

All HBsAg(+) mothers, including those on TDF or TAF, should be educated on the value and safety of breastfeeding and that HBV is not transmitted through breastmilk. Breastfeeding mothers with cracked nipples should practice proper nipple care and be informed that infant receipt of HBV vaccination and HBIG will protect against HBV acquisition from such blood exposures.

Management if Mother HBsAg (-)

Evaluate Immunity

Interpret HBV serology and provide appropriate next step:

  • If HBV susceptible and at high risk for HBV infection, vaccinate during pregnancy6
    Note 6: Engerix-B, Recombivax-HB, Heplisav-B, and Twinrix are safe to give at any time during pregnancy; however Heplisav-B and Twinrix are approved for use among those aged 18 years and older.

Infant Management

ALL infants of HBsAg(-) women should:

  • Receive birth dose HBV vaccine within 24 hours of birth
  • Complete HBV vaccine series on schedule5
Note 5: For infants weighing less than 2,000 grams, the birth dose does not count toward the vaccine series, and the infant should receive another HBV vaccine one month after birth.
Footnotes
1 All pregnant women should be screened for HBV (with HBsAg at minimum) during each pregnancy, regardless of prior HBV screening results. For complete HBV profile, add anti-HBs to determine immunity and anti-HBc IgG or total for evidence of prior infection.
2 All HBsAg(+) mothers should be educated on the importance of regular follow-up during and after the pregnancy so that appropriate HBV monitoring can occur, especially since the postpartum period is a time of increased risk for hepatitis B flares.
3 If an HBsAg(+) woman is taking entecavir when she becomes pregnant, the antiviral regimen should immediately be switched to tenofovir disoproxil fumarate (TDF) or tenofovir alafenamide (TAF) if she is not already taking one of these medications.
4 If HBV DNA <200,000 IU/mL in the first trimester, consider retesting in the second trimester as viral load may rise.
5 For infants weighing less than 2,000 grams, the birth dose does not count toward the vaccine series, and the infant should receive another HBV vaccine one month after birth.
6 Engerix-B, Recombivax-HB, Heplisav-B, and Twinrix are safe to give at any time during pregnancy; however Heplisav-B and Twinrix are approved for use among those aged 18 years and older.
Abbreviations
MTCT = mother-to-child transmission
TDF = tenofovir disoproxil fumarate
TAF = tenofovir alafenamide
HBIG = hepatitis B immune globulin

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