Fam Pract Manag. 2025;32(4):37-42
The publication of this content is funded by an unrestricted grant from Dynavax Technologies Corporation and brought to you by the AAFP. Journal editors were not involved in the development of the content.
Hepatitis B is a virus that affects the liver, causing acute infection through percutaneous, mucosal or nonintact skin contact with infected blood, semen and/or other body fluids.1 Approximately 70% of adults with acute hepatitis B will develop symptoms, which can appear an average of 90 days after exposure to the virus.2 Symptoms may include nausea, vomiting, abdominal pain, dark urine or clay-colored stools, fatigue, fever, joint pain and jaundice.1,2
This supplement will guide you through screening and testing recommendations (including risk factors for hepatitis B infection), current vaccine recommendations, integrating the recommendations into your practice and the social determinants of health associated with hepatitis B.
Clinical Consideration
A new patient arrives in your clinic and asks about hepatitis B vaccination. His daughter is currently in medical school, and she recommended your patient talk with you about being screened for hepatitis B infection and possibly receiving the vaccine. The patient is a healthy, physically active 55-year-old male with no medical conditions. He would like more information on hepatitis B infection and vaccination, as he has never been tested or received the vaccine series. He inquires if you recommend the vaccine for him despite having no medical issues. What is your recommendation? How would you counsel this patient to increase the likelihood he follows your recommendation?
History
The first hepatitis B vaccine was introduced in the United States in 1981.3 The following year, the hepatitis B vaccine was recommended for high-risk individuals, including health care workers who may be exposed to blood, bodily fluids and needles.4 In 1991, the Advisory Committee on Immunization Practices began recommending hepatitis B vaccination for all infants,5 and by the mid-1990s, most states had hepatitis B vaccine entry requirements for elementary schools and childcare centers.6 As a result, from 1986 to 2000, the rate of acute hepatitis B among children 1–9 years declined by more than 80%. A 98% decline in HBV infections occurred among health care personnel from 1983 to 2010.12 Despite the advances to increase vaccination among young people, the estimated prevalence of adults living with chronic hepatitis B in the United States remained unchanged at 0.3% between 1999 and 2018.3 In 2022, 89% of newly reported cases of chronic hepatitis B in the United States were in adults 30 years and older.13
Fast Stats
About 90% of infected infants and 5% of infected adults will become chronically infected with hepatitis B.1
According to two estimates, anywhere from 580,000 to 2.4 million people may be living with chronic hepatitis B virus infection in the United States.7,8 The higher estimate considers the potential underrepresentation of people not born in the United States.
An alarming 15–25% of people with chronic infection develop cirrhosis, liver failure and/or liver cancer.1
Among patients in the United States currently diagnosed with hepatocellular carcinoma, 10–15% are infected with the HBV.9
In 2022, there were 1,797 reported deaths related to hepatitis B.10
In 2019 alone, the total cost of hospitalizations of patients with chronic hepatitis B was $809 million.11
Screening and Testing Recommendations
The goal of the World Health Organization is to eliminate hepatitis B worldwide by 2030.14 To help achieve this goal, the ACIP updated recommendations for hepatitis B vaccination in 2022, and the Centers for Disease Control and Prevention updated its recommendations for hepatitis B screening the following year.15 Prior to 2023, screening for hepatitis B infection was based on the risk for infection. Health care providers were to assess a patient’s risk for hepatitis B by asking about potential behavioral exposures, such as intravenous drug use and men who have sex with men.16 This could be challenging, as health care providers felt unprepared to properly assess risk, and this conversation could be perceived as stigmatizing to patients. It was also recommended to screen patients who are immunosuppressed, those with liver disease of an unknown cause and those born in a region where the prevalence of hepatitis B surface antigen, or HBsAg, positivity was 2% or greater. These risk indicators to screen were added to a list of patients who should already be screened, including pregnant women and sexual partners of individuals with hepatitis B.
According to the Viral Hepatitis National Strategic Plan for the United States, from 2013–2016, only 32% of people with hepatitis B infection were aware of their condition.17 To increase awareness and treatment, the CDC now recommends a one-time universal screening for hepatitis B in all adults 18 years and older.15 People who are pregnant should continue to be screened with each pregnancy, preferably during the first trimester, regardless of vaccination status or testing history. However, low-risk people who are pregnant with no potential additional exposures to hepatitis B may choose to forgo screening with subsequent pregnancies.
Testing for hepatitis B should be done for patients of any age with risk for hepatitis B exposure if their potential exposure occurred during a time when they were not known to be immune to hepatitis B, either from vaccination or previous infection.18
Infants born to people who are pregnant and HBsAg-positive
People born in regions with HBV infection prevalence of 2% or greater
U.S.-born people not vaccinated as infants whose parents were born in areas with HBV infection prevalence of 8% or greater
People who inject drugs or with a history of injection drug use
People who are incarcerated or formerly incarcerated in a jail, prison or other detention setting (new recommendation)
People with human immunodeficiency virus infection
People with a history of past or current hepatitis C virus infection (new recommendation)
Men who have sex with men
People with a history of sexually transmitted infections or multiple sex partners (new recommendation)
People with household contacts or former household contacts of people with known HBV infection
People who have shared needles with or engaged in sexual contact with people with known HBV infection
People on maintenance dialysis, including in-center or home hemodialysis and peritoneal dialysis
People with elevated alanine aminotransferase or aspartate aminotransferase levels of unknown origin
People who request HBV testing (new recommendation)
Patients who have ongoing risks of exposure to hepatitis B should periodically be tested. It is important to note the recommendations also include testing all patients who request testing for hepatitis B, regardless of whether there has been a discussion on risks for HBV infection. This new recommendation decreases barriers to testing that may have existed with the previous risk-based testing recommendations.
Hepatitis B surface antigen or HBsAg: HBsAg is positive in acute and chronic infection. It will also be transiently positive if tested within 30 days after an injection with the hepatitis B vaccine.
Hepatitis B surface antibody or anti-HBs: Anti-HBs will become positive with recovery from acute hepatitis B, vaccination from hepatitis B and 4–6 months after infusion of hepatitis B immune globulin.
Hepatitis B core antibody or anti-HBc: Anti-HBc will be present, typically for life, in individuals who have had HBV infection, whether it is resolved or has become chronic.
Compared with previous risk-based screening, one study demonstrated that “universal screening would avert an additional 7.4 cases of compensated cirrhosis, 3.3 cases of decompensated cirrhosis, 5.5 cases of hepatocellular carcinoma, 1.9 liver transplants and 10.3 hepatitis B virus-related deaths at a savings of $263,000 [per] 100,000 adults screened.”20
Family physicians should discuss regularly with their patients and make decisions together on the timing and frequency of any periodic testing for hepatitis B. The CDC recommends patients who have not completed the hepatitis B vaccine series should be offered screening for and vaccination against hepatitis B at the same visit. Ideally, patients should have their blood drawn before receiving the first dose of the hepatitis B vaccine.16
Vaccination Recommendations
In the United States, it is recommended that the following people should receive the hepatitis B vaccine21:
All ages from birth through 59 years
Adults 60 years and older with high-risk factors for hepatitis B
The hepatitis B vaccine is currently a component of Pediarix, Vaxelis and Twinrix.21 Pediarix (i.e., tetanus, diphtheria, pertussis, polio, hepatitis B) is approved for patients six weeks through six years; Vaxelis (i.e., tetanus, diphtheria, pertussis, polio, Haemophilus influenzae type b, hepatitis B) is approved for patients six weeks through four years; and Twinrix (i.e., hepatitis A, hepatitis B) is approved for patients 18 years and older.
Currently, there are three monovalent hepatitis B vaccines approved by the U.S. Food and Drug Administration.22 Energix-B is approved for patients in all age groups. Heplisav-B is approved for patients 18 years and older. Recombivax HB is approved for patients in all age groups.
PreHevbrio was approved for patients 18 years and older and was available in the United States until November 2024, when the vaccine manufacturer recalled all remaining doses due to the company declaring bankruptcy.21 Patients who received one or two doses of PreHevbrio should complete a three-dose series with a different available hepatitis B vaccine.
For routine indications, Energix-B, Recombivax HB and Twinrix are three-dose series vaccines given at 0, 1 and 6 months.23 Heplisav-B is a two-dose vaccine series given at least four weeks apart. The United States Department of Health and Human Services recommends preferentially for use of Heplisav-B for people with HIV.24
Patients on dialysis who have not already been vaccinated against hepatitis B should receive either three doses of Recombivax HB at the standard dosing intervals but with 40 micrograms instead of the routine 10 mcg or Energix-B at 0, 1, 2 and 6 months with 40 mcg instead of the routine 20 mcg.25,26 The safety and efficacy of Heplisav-B have not been established in adults requiring chronic dialysis.27
Adults who have an immunocompromising condition and have not been vaccinated against hepatitis B should receive either three doses of Recombivax HB at the standard dosing intervals but with 40 mcg instead of the routine 10 mcg, Energix-B at 0, 1, 2 and 6 months with 40 mcg instead of the routine 20 mcg or Heplisav-B at the standard dosing and interval.28
An accelerated schedule exists for situations where patients whose risks for hepatitis B exposure may be imminent, such as travel to hepatitis B endemic areas, health care workers that may be exposed to hepatitis B, disaster relief workers and family members of hepatitis B carriers.16 The accelerated dosing schedule for patients one year and older (including adults) with Energix-B is 0, 1 and 2 months, with or without a booster dose at 12 months, depending on the patient’s age.16,31 For adults 18 years and older, the accelerated dosing interval for Heplisav-B is the same as the standard interval of two doses, one month apart. For adults 18 years and older, the accelerated dosing schedule for Twinrix is 0, 1 week, 1 month and 12 months. With Recombivax HB, an accelerated/alternative schedule may be used for children 11–15 years at 0 and 4–6 months.
Hepatitis B vaccines are created by inserting hepatitis B surface antigen into cells of the yeast Saccharomyces cerevisiae, also known as brewer’s or baker’s yeast.32 Severe allergy, such as an anaphylactic reaction to yeast, is a contraindication to receiving hepatitis B vaccines. Additional contraindications include any previous severe allergic reaction to a dose of hepatitis B or any severe allergic reaction to a component of the vaccine.21 Precautions for giving a hepatitis B vaccine dose include any moderate or severe acute illness regardless of current fever.33 Fatigue, headache and soreness or redness at the injection site are the most commonly reported side effects of hepatitis B vaccines.22
Despite these few contraindications and precautions, the hepatitis B vaccines are remarkably effective. They have been shown to protect 94–98% of vaccinated individuals from chronic hepatitis B.34 Studies have demonstrated continued effectiveness in 86% of individuals vaccinated in infancy 35 years later.35 A study of health care students in highly developed countries demonstrated a 91% effectiveness for more than two decades after vaccination.36
Integrating Current Hepatitis B Recommendations into the Adult Vaccination Platform
Family physicians must remain up to date on current recommendations for hepatitis B screening and vaccination to educate patients effectively. The CDC and ACIP recommendations for universal screening and vaccination up to 60 years aim to increase awareness of hepatitis B status and decrease the incidence of HBV infection and complications from chronic hepatitis B. Family physicians play a vital role in implementing these recommendations. Most states in the United States require hepatitis B vaccination to enter school. As a result, hepatitis B vaccination rates among children entering school (i.e., kindergarteners) were nearly 94% to start the 2023–24 school year.37 However, as of 2021, only 34% of U.S. adults 19 years and older were vaccinated against hepatitis B.38 While for years it has been standard practice to discuss hepatitis B vaccination with parents of infants receiving the hepatitis B vaccine, family physicians should also now focus on how to approach adult patients regarding hepatitis B screening and vaccination. By creating recommendations for universal screening and vaccination of patients under 60 years, the CDC and ACIP have simplified the discussion family physicians should have with their patients.
Family physicians should add discussing hepatitis B screening or testing and hepatitis B vaccination into their current workflow at a patient visit. During a preventive visit or annual checkup, family physicians can add to their discussion on adult vaccines with the hepatitis B vaccine recommendations. Per the recommendations, family physicians should offer screening to all patients who have never been screened or test patients with previous risk or an ongoing risk for hepatitis B infection.15 During this visit, family physicians can also offer to give the first dose of the hepatitis B vaccine to patients who have never been vaccinated against hepatitis B. This should include discussing recommendations with patients 60 years and older so that these patients can receive the vaccine if they want it. If a patient is unaware of their vaccination or infection status, this should not prevent family physicians from offering testing and vaccination at the same visit.
Electronic health records can assist with increasing awareness of infection through documentation of disease diagnosis. EHRs can also improve screening and vaccination rates by including this information in a “health maintenance” or “care gap” section of EHR dashboards. Health systems can implement standing orders for hepatitis B vaccines to empower other health care staff to participate in increasing vaccination rates. Another way to utilize EHRs to assist is by creating order sets for both the triple panel testing and vaccines.39 For the hepatitis B vaccine, this order set would then automatically place orders for future doses of hepatitis B. Depending on the brand of hepatitis B vaccine, the order set would include appropriate timing and number of doses. The EHR can then also remind patients through the patient portal when they are due for their next dose of the hepatitis B vaccine.
Hepatitis B and the Social Determinants of Health
Approximately 254 million people worldwide were living with chronic hepatitis B in 2022, with an estimated 1.2 million new infections occurring yearly.40 Hepatitis B is also a public health concern in the United States, particularly among foreign-born people. One study from 2018 found that approximately 59% of foreign-born people with chronic hepatitis B in the United States emigrated from Asia, 19% from the Americas (the majority from the Caribbean) and 15% from Africa.41 While people living in the United States who were born outside of the country made up 14% of the U.S. population, they comprised 60–90% of those living with chronic hepatitis B in the country.
Studies have shown that the social determinants of health – the non-medical factors that shape a person’s health and well-being – contribute to testing and vaccination barriers for hepatitis B.42 Particularly in those patients not born in the United States, SDOH, such as insurance coverage, socioeconomic status, cultural factors and language, influence access to testing and treatment for hepatitis B.
In 2022, non-Hispanic Black or African Americans were more than four times as likely to be diagnosed with chronic hepatitis B as non-Hispanic whites.43 Non-Hispanic Black or African Americans were also more than twice as likely to die from hepatitis B than non-Hispanic whites. Likewise, while Asian Americans account for only 6% of the U.S. population, they account for almost 58% of Americans living with chronic hepatitis B.44
Lack of access to treatment, insurance coverage and vaccination were the root causes of these disparities, as non-Hispanic white adults 19–49 years (48%) are more likely to receive at least one dose of hepatitis B vaccine compared to non-Hispanic Black adults 19–49 years (34%).43 The prevalence of chronic hepatitis B in the United States is also higher in individuals without insurance coverage.44
Interventions to improve rates of screening and vaccination for hepatitis B need to be mindful of the SDOH that contribute to the disproportionate rates of individuals who are unaware of their hepatitis B status and have challenges accessing treatment. The Viral Hepatitis National Strategic Plan for the United States recommends implementing hepatitis B screening and vaccination programs in settings where often marginalized communities receive other resources, such as shelters for people experiencing homelessness, clinics for people with STIs and centers for people who are refugees.17 The plan includes engaging faith-based and community leaders to assist in reducing stigma regarding hepatitis B screening and treatment.
Family Physician’s Role
To eliminate all hepatitis B in the United States, the U.S. Department of Health and Human Services is educating physicians to better understand HBV infection, treatment and prevention. Family physicians should feel comfortable and knowledgeable when discussing hepatitis B with their patients. By creating a safe and non-judgmental space for patients, family physicians can increase their patients’ likelihood of adopting current screening and vaccination recommendations. Other effective interventions include virtual patient education and bilingual community health educators.44
The CDC, American Academy of Family Physicians and Hepatitis B Foundation are among the many organizations with accurate information family physicians can access to assist with hepatitis B conversations. Patients may have questions and concerns regarding the importance of screening and vaccination. Family physicians can reference the high rates of liver cancer in people with chronic hepatitis B and emphasize the cancer prevention aspect of vaccination.47 They can also stress the importance of screening because many people with hepatitis B do not have symptoms. Reassure patients who had a dose of the hepatitis B vaccine but did not complete the series on time that they may continue with the next dose in the series and do not need to repeat a previous dose. Switching among manufacturers of hepatitis B vaccines is also acceptable, if needed.
Family physicians can significantly impact decreasing rates of hepatitis B in the United States by adopting the current recommendations for screening, testing and vaccinating patients. Online resources for physicians provide valuable information on ordering and interpreting tests and addressing frequently asked questions by patients. EHR systems can be optimized to provide physicians with prompts and patient reminders for screening and vaccination.
When considering disproportionately affected communities in the United States, it is clear that SDOH influences hepatitis B infection rates. By addressing the SDOH unique to each patient and approaching each patient with empathy, family physicians can play an integral role in eliminating hepatitis B in the United States among all patient populations.
