Guidance

Hepatitis B immunoglobulin (issued November 2023)

Updated 7 November 2024

Applies to England

Human hepatitis B specific immunoglobulin for hepatitis B post-exposure prophylaxis

Overview

Human hepatitis B specific immunoglobulin (HBIG) is supplied by Bio Products Laboratory (BPL) for post-exposure use to prevent hepatitis B infection.

HBIG is dispensed in vials of 500 IU or 200 IU by BPL.

Indications

HBIG is normally used in combination with hepatitis B vaccine to confer passive/active immunity in the following groups.

Newborn of mothers who are:

• persistently infected with hepatitis B surface antigen (HBsAg), where hepatitis B e antigen (HBeAg) is detectable or its antibody (anti-HBe) is not
• HBsAg positive and known to have a HBV DNA level equal to or above 1 x 10⁶ IU/ml
• HBsAg positive as a result of recent acute infection
• HBsAg positive and the baby’s birth weight is 1,500g or less regardless of e-antigen status or HBV DNA (viral load) of mother

Accidental exposure by blood or other material known to contain HBsAg through:

• percutaneous inoculation (needlestick or other ‘sharp’, bites, scratches)
• contamination of mucous membranes (spillage into eyes or mouth)
• contamination of non-intact skin (open wounds, dermatitis or eczema)
• the virus does not cross intact skin

Sexual contacts:

• of individuals suffering from acute hepatitis B who are seen within one week of last contact should be offered HBIG and vaccine
• of individuals with newly diagnosed chronic hepatitis B should be offered vaccine – HBIG may be given in addition if unprotected sexual contact occurred in the past 7 days
• other exposed contacts get vaccine only

Dosage

Dosage is as follows:

• 0 to 4 years – 200 - 250 IU*
• 5 to 9 years – 300 IU
• 10 years and older – 500 IU

*200 - 250 IU is to allow for the fact that 200 IU vials may soon become available again, in addition to 500 IU vials.

Administration

HBIG should be given by intramuscular injection at the same time as vaccine (but different site) as soon as possible, preferably within 24 hours and ideally within 48 hours after vaccine – but no later than a week after exposure.

Hepatitis B vaccine should never be delayed while waiting for HBIG administration.

Recommendations

Newborns

Babies are considered ‘high risk’ of maternal-to-child transmission and should receive HBIG and vaccine if:

• mother is HBsAg seropositive and HBeAg seropositive
• mother is HBsAg seropositive and HBeAg/anti-HBe negative
• mother is HBsAg seropositive and e markers are not available
• mother has acute hepatitis B in pregnancy
• mother is HBsAg seropositive and infant is born weighing 1,500g or less
• mother is HBsAg seropositive and known to have an HBV DNA level equal to or above 1 x 10⁶ IU/ml in any antenatal sample in this pregnancy

Babies receive hepatitis B vaccine but do not receive HBIG if none of the above criteria for newborns apply, for example if the mother is anti-HBe positive and HBeAg negative and newborn does not have a low birthweight.

HBIG for newborns will be issued where one or more of the e-markers are unknown. If in doubt, issue, as delay in administration could reduce the chances of preventing transmission.

Requests for HBIG for neonates (both routine (advance) and emergency issues) must be accompanied by an issuing form. The issuing form is available to download from the Hepatitis B page of GOV.UK.

Post-exposure for individuals who have been vaccinated

Individuals who have already been fully vaccinated with a primary course and had a significant exposure to a known HBsAg source should be given a booster dose of hepatitis B vaccine (without immunoglobulin) unless the booster dose was given within the past year.

For those who have been partially vaccinated, one dose of vaccine should be given and the course completed.

Post-exposure for non-responders

Health care workers who have received a full course of hepatitis B vaccine and have not responded (hepatitis B surface antibody (anti-HBs) <10 mIU/ml, taken 1 to 2 months after completion of the course) should be given HBIG post exposure (and vaccine).

Serum for HBsAg should be urgently obtained from the source as if HBsAg negative no HBIG is required.

If not already done, serum for HBsAg and anti-HBcore should also be taken from the health care worker to check that hepatitis B infection is not the reason for their non-response to vaccine.

Serum for anti-HBs should be taken from the health care worker and repeated one month after vaccine to confirm their non-responder status (particularly if previous anti-HBs tests were not done at the correct interval after the course of vaccine). An anti-HBs level of over 50 mIU/ml taken one month after HBIG and vaccine administration is likely to be attributable to immune response to vaccine (over 10 mIU/ml) in addition to circulating HBIG ^{[footnote 1]} and so the health care worker has responded to vaccine. If anti-HBs is equal to or below 50 mIU/ml it is unlikely that the health care worker has responded to the dose of vaccine.

A second dose of immunoglobulin should be administered one month after the first, unless the source is shown to be HBsAg negative, or the health care worker’s non-responder status is refuted.

If not already previously attempted, a second full course of vaccine can be completed and anti-HBs repeated 1 to 2 months after completion as per Green Book.

All test results, vaccine and HBIG administration should be recorded with dates in the occupational health records of the health care worker. If appropriate following repeat testing, non-responder status should be redacted or corrected in their records and the health care worker informed.

Guidance for issuers

1. Vaccine is the most important intervention and this should be carried out as soon as possible and not delayed whilst awaiting HBIG or test results.
2. HBIG is not available for the treatment of any type of chronic hepatitis B infection.
3. HBIG is not available for travellers to areas of high hepatitis B endemicity – vaccine should be considered.
4. HBIG will not inhibit the antibody response when given at the same time as hepatitis B vaccine, but should be given in different sites.

Resources

Further information on the use of passive immunisation with HBIG for infants born to hepatitis B-infected mothers is available on GOV.UK.

Guidance on the antenatal screening and selective neonatal immunisation programme is available at GOV.UK.

Full guidance on hepatitis B prophylaxis for reported exposure incidents is in The Green Book, chapter 18: Hepatitis B.

1. Based on a pharmacokinetics calculator that estimates concentration of immunoglobulins administered intramuscularly at different timepoints based on adult weight of 60 to 90 kg; formula adapted from: Young MK, Ng SK, Nimmo GR, Cripps AW. ‘The optimal dose of disease-specific antibodies for post-exposure prophylaxis of measles and rubella in Australia: new guidelines recommended’, Expert Opinion on Drug Metabolism and Toxicology, 2018. ↩