VACCINATION, RISK IDENTIFICATION, AND TESTING

Routine Vaccination in Children. The Advisory Committee on Immunization Practices (ACIP) recommends universal hepatitis B vaccination for all infants born in the US and children through age 18 years, starting with a birth dose, followed by a second vaccine dose at 1 to 2 months and a final vaccine dose at 6 to 18 months, according to its immunization schedule.1,15 In infants born to infected mothers, administer the first dose of hepatitis B vaccine and hepatitis B immune globulin (HBIG) within 12 hours of birth, or as soon as possible, but no later than 7 days after birth. Administer the second vaccine dose at 1 to 2 months, and the final vaccine dose at 6 months.1,15 For hepatitis B vaccine, the final dose in the series needs to be given no earlier than 24 weeks of age, and at least 16 weeks after the first dose.15 If one of the doses administered after the birth dose is a combination vaccine and 3 doses are given prior to 24 weeks of age, a fourth dose should be given at or after 24 weeks; see Resources--ACIP recommendations.15 Testing for HBV infection should not be performed before age 9 months or within 1 month of the most recent vaccine, in order to avoid detection of antibodies to HBsAg from HBIG and to maximize the likelihood of detection of late infection.1,3

Previously unvaccinated children and adolescents age 7 through 18 years should receive 3 doses of hepatitis B vaccine as soon as feasible according to the ACIP schedule. Incompletely vaccinated patients age 4 months through 18 years who start late or are more than 1 month behind in their vaccinations should receive the 3-dose vaccine series according to the ACIP-recommended catch-up schedule (Resources).15

Identifying Risk in Adults. Routinely ask all patients about HBV risk factors (see Box 1) and provide appropriate testing and vaccination (Table 1).8,10,14 Counsel infected patients about preventing liver damage and disease transmission (see Box 2 and Resources).

Testing. Test patients with risk factors, including those born in regions with a 2% or higher prevalence of chronic hepatitis B infection and US-born people whose parents were born in high-prevalence regions (see Box 1 and Table 1),3,10 even if vaccinated, because they may have developed chronic hepatitis B infection before being vaccinated. Provide culturally appropriate educational materials to help patients understand the need for HBV testing and to those who have chronic HBV infection (Resources). Stigma or discrimination in their country of origin may deter people from being tested and obtaining follow-up care, even after immigration to the US.10

Approximately 79% of new cases of HBV infection in the US result from high-risk sexual activity and injection drug use.14 Testing is recommended for MSM, IDUs, and close contacts of HBsAg-positive patients. Testing is recommended even for vaccinated patients if they were vaccinated after initiation of risk behaviors.3 Several blood tests are available to detect the presence and phase of acute or chronic hepatitis B infection.8,14,23 The markers used to identify acute, resolving, and chronic hepatitis B infections are:

  • HBsAg, a marker of HBV infection, either acute or chronic; can (rarely) have a false-positive result;
  • Anti-HBs or HBsAb (antibody against HBs antigen), a marker of immunity to HBV through vaccination or resolved natural infection;
  • Total anti-HBc or HBcAb (total HB core antibody), a marker of past or present infection in an undefined time frame;
  • IgM-anti-HBc (IgM antibody against HBc antigen), a marker of acute HBV infection for less than 6 months (false-positives often seen in those with chronic hepatitis B infection; generally useful only when acute infection is suspected);
  • HBV DNA ("viral load"), if detectable, indicates the presence of chronic infection;
  • HBeAg (hepatitis B "e" antigen), associated with a high HBV viral load;
  • Anti-HBe (antibody against HBe antigen), associated with a lower viral load.

See Tables 1 and 2 for testing recommendations and interpretation of test results.

Protection With Vaccination for Adults. There is evidence that vaccination provides long-term protection against HBV infection for at least 20 years. Factors at the time of vaccination such as older age, smoking, obesity, and immunosuppression contribute to decreased vaccine response.14 Vaccinate anyone aged 19 years or older who wishes to be protected against HBV, even without an acknowledged risk factor. Recommend HBV vaccination for all unvaccinated adults aged 19 years and older with the following indications8,10,14,16:

Behavioral risk: MSM, current or recent IDUs, people with more than 1 sex partner in the past 6 months, and people seeking evaluation or treatment for a sexually transmitted infection;

Occupational risk: health care and public safety workers who are exposed to blood or other potentially infectious body fluids;

Medical risk: people with HIV or chronic liver disease, end-stage renal disease, including predialysis, hemodialysis, peritoneal dialysis, and home dialysis patients. Adults with diabetes aged 19 through 59 years should receive vaccination, and those aged 60 years and older may receive it at the physician's discretion (considering likelihood of patient acquiring HBV infection from blood glucose monitoring in facilities, having chronic sequelae, or declining immunologic responses to vaccine).22

Other risk: household contacts and sex partners of people with chronic hepatitis B, clients and staff members of institutions for people with developmental disabilities, and international travelers to areas with high or intermediate prevalence of chronic hepatitis B. Promptly vaccinate pregnant women with any risk factor.1 Limited data show no apparent risk for adverse events in the developing fetus.18

Identify all susceptible household, sex, and needle-sharing contacts of HBsAg-positive people by testing for HBsAg and anti-HBc or
anti-HBs; begin vaccination at the same visit, after drawing blood. If the person is HBsAg positive, there is no need to continue the series. Susceptible contacts who have not yet been vaccinated or whose vaccination status is uncertain should receive the complete vaccine series.3 People who are not fully vaccinated should complete the vaccine series.1,14

Administer the full 3-dose HBV vaccine series over a 6-month period, injecting into the deltoid muscle at a 90° angle.3,16 In healthy adults aged 40 years and younger, vaccine efficacy is greater than 90% with the full 3-dose series, but declines to 75% if only 2 doses are received and 30% to 50% with only 1 dose.14 The 3-dose series does not need to be restarted if the vaccination schedule is interrupted. Because 1 dose will confer at least partial protection, administer vaccine even if you are unsure whether patients will get subsequent doses. Hepatitis B vaccine is contraindicated if the patient has had a severe allergic reaction (eg, anaphylaxis) after a previous dose or an allergy to any vaccine component (Resources--CDC Recommended Adult Immunization).14

Postvaccination serologic testing 1 to 2 months after the last vaccine dose is recommended only for chronic hemodialysis, HIV-infected, and other immunocompromised patients; infants born to HBsAg-positive mothers; sex and needle-sharing partners of HBsAg-positive individuals; and health care personnel at ongoing risk for injury with sharp instruments or needlesticks.5,14,24 People who do not have a documented positive anti-HBs test after the first series of HBV vaccine should complete a second 3-dose series.5 Less than 5% of people receiving 6 doses of HBV vaccine are nonresponders. Persistent nonresponse may be due to chronic hepatitis B5 or HIV infection.25 People who do not respond after 6 doses should be tested for HBsAg and total anti-HBc because HBsAg may be negative in people with occult infection or an HBsAg mutation. Those who have negative HBsAg after the second series should be considered susceptible to HBV infection and counseled appropriately.14

 

TABLE 1. RECOMMENDATIONS FOR HEPATITIS B VIRUS TESTING AND VACCINATION

At-Risk Population

Testa

Vaccinate

People born in regions of high and intermediate HBV endemicity (HBsAg prevalence equal to or greater than 2%),b including undocumented and migrant workers, refugees, asylum seekers, and internationally adopted children8,14

HBsAg, anti-HBs, and anti-HBc, regardless of immunization status in their country of origin

If susceptible

US-born people whose parents were born in regions of high endemicity (HBsAg prevalence equal to or greater than 8%)b,8,14

HBsAg, anti-HBs, and anti-HBc, regardless of mother's immunization status

If susceptible

Injection drug users8,14
Men who have sex with men8,14
Household, needle-sharing, or sexual contacts of people known to be HBsAg-positive8,14

If unvaccinated or if vaccinated after
initiation of potential exposure: HBsAg and anti-HBs or anti-HBc

Give first dose at time of testing, after the blood draw.
If HBsAg-positive, no need to complete vaccine series

People with more than 1 sex partner in past 6 months8,14
People seeking evaluation or treatment for a sexually transmitted infection8,14

Consider HBsAg and anti-HBs

If unvaccinated or if tested and susceptible

People with tattoo/piercing from a nonprofessional provider

HBsAg and anti-HBs

If susceptible

Patients with chronic liver disease8,14

HBsAg, anti-HBs, and anti-HBc

If susceptible

Patients on immunosuppressive therapy, eg, chemotherapy, or who are immunosuppressed due to organ transplantation or rheumatologic or gastroenterologic disorders8,14

HBsAg, anti-HBs, and anti-HBc

If susceptible; larger or more vaccine doses may be requiredc

People with elevated ALT/AST of unknown etiology8,14

HBsAg and anti-HBs, physical examination, and liver function testing

If susceptible

Donors of blood, plasma, organs, tissues, or semen14

HBsAg, anti-HBs, and anti-HBcd

 

People with end-stage renal disease, including those on hemodialysis, predialysis, peritoneal dialysis, and home dialysis8,14

For hemodialysis, HBsAg, anti-HBc, and anti-HBs. Monthly HBsAg test for nonresponders.
Check anti-HBs titers annually

If susceptible. The 40-µg dose formulation is recommended
for these adults.
If anti-HBs titers are <10 mIU/mL, give booster dose

HIV-positive people8,14

HBsAg, anti-HBs, and anti-HBc

If susceptible

All pregnant women8,14

HBsAg, preferably first trimester. Retest at delivery if HBsAg test result is not available or if mother had risk factor while pregnant.
Report all cases of HBsAg-positive
pregnant women to the NYC Health Department

If there is a risk factor. Give first dose at time of testing, after the blood draw. If HBsAg-positive, no need to complete vaccine series

Infants born to HBsAg-positive mothers1,5,14

HBsAg and anti-HBs 1-2 months after completion of vaccine series.
Do not test before age 9 months or within 1 month of most recent vaccine dose

HBIG and first dose of hepatitis B vaccine within 12 hours of delivery

People who have been exposed to potential HBV-infected blood or body fluids (eg, needlestick, sexual assault)14

HBsAg (source and exposed person)

If exposed person is unvaccinated, provide HBIG and first dose of vaccinec

Adults with diabetes aged 19 through 59 years22
Adults with diabetes aged 60 years and older, at provider's discretion (see Vaccination section)22

Consider HBsAg and anti-HBs

If unvaccinated, as soon as possible after diagnosis, or if tested and susceptible

Clients and staff members of institutions for people with developmental disabilities14

Consider HBsAg and anti-HBs

If susceptible

International travelers to areas with high or intermediate HBV endemicityb,14,19

Consider HBsAg and anti-HBs

If susceptible

ALT = alanine aminotransferase; AST = aspartate aminotransferase; HBIG = hepatitis B immune globulin; HBsAg = hepatitis B surface antigen; anti-HBc = antibody to hepatitis B core antigen; anti-HBs = antibody to HBsAg.
aDo not test for HBsAg within 1 month after vaccinating as a false-positive result is possible.
bHigh endemicity (HBsAg equal to or greater than 8%): Africa and East and Southeast Asia, including China, Korea, Indonesia, and the Philippines; the Middle East, except Israel; South and Western Pacific islands; the interior Amazon River Basin. Intermediate endemicity (HBsAg 2%-7%): South, Central, and Southwest Asia; Israel; Japan; Eastern and Southern Europe; Russia; most areas surrounding the Amazon River Basin; Honduras; Guatemala; Haiti; Dominican Republic; Hawaii.
cSee www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepb.pdf, p. 125 for immunocompromised persons recommendations and p. 136 for occupational exposure.
dHepatitis B screening required by Code of Federal Regulations. Title 21. Food and Drugs. Part 610.40.

 

TABLE 2. INTERPRETING HEPATITIS B SEROLOGIC TEST RESULTS

Serologic marker

Interpretation

HBsAg

Total anti-HBc

IgM anti-HBca

Anti-HBs

 

Susceptible; never infected

+

Early acute infection; transient postvaccination result

+

+

+

Acute infection that could become chronica

+

+

or +

Acute resolving infection

+

Vaccinated and immune

+

+

Recovered from past infection and immune

+

+

Chronic infection

+

Several possible explanations: Resolved infection (possibly remote) in high-prevalence populations; chronic infection in high-prevalence or HIV/HCV populations; or false-positive3

= negative test result; + = positive test result.

HBsAg = hepatitis B surface antigen; total anti-HBc = total antibody to hepatitis B core antigen; IgM anti-HBc = immunoglobulin antibody against HBc antigen;
anti-HBs = antibody to HBsAg.

aIgM tests are most useful when there is a clinical suspicion of acute HBV infection and can give false-positive results in people with established diagnoses of chronic hepatitis B. Adapted from Mast EE, et al. MMWR Recomm Rep. 2006;55(RR-16):1-33 and Weinbaum CM, et al. MMWR Recomm Rep. 2008;57(RR-8):1-28.

 

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