What is the recommended post-exposure prophylaxis (PEP) for a patient with no prior vaccination against Hepatitis B (HBV) following exposure to Hepatitis B?

From the Guidelines

For an unvaccinated patient with hepatitis B exposure, the recommended post-exposure prophylaxis includes both hepatitis B immune globulin (HBIG) and the hepatitis B vaccine series, as stated in the most recent guidelines from 2021 1. The guidelines emphasize the importance of initiating immunoprophylaxis as soon as possible, preferably within 24 hours, but effective up to 7 days for percutaneous exposures and 14 days for sexual exposures.

• HBIG (0.06 mL/kg or 500 IU for adults) should be administered at a separate injection site from the hepatitis B vaccine.
• The complete vaccine series consists of three doses: the initial dose, followed by doses at 1 month and 6 months after the first dose. This dual approach provides both immediate passive immunity through HBIG and long-term active immunity through the vaccine series, with efficacy rates of 85-95% in preventing hepatitis B infection, as supported by previous studies 1. Key considerations include:
• The hepatitis B vaccine series should be completed according to the vaccination schedule.
• Blood testing should be performed 1-2 months after completing the vaccine series to confirm immunity.
• If the patient is known to be a non-responder to previous hepatitis B vaccination, alternative approaches may be necessary, such as two doses of HBIG given one month apart.

From the FDA Drug Label

For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure (its value beyond 7 days of exposure is unclear). Table 1 (adapted from (21)) Recommendations for Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure Exposed Person Source | Unvaccinated | Vaccinated HBsAg-Positive | 1. Hepatitis B Immune Globulin (Human) x1 immediately* | 1. Test exposed person for anti-HBs. | 2. Initiate HB Vaccine Series† | 2 If inadequate antibody,‡ Hepatitis B Immune Globulin (Human) (x1) immediately plus HB Vaccine booster dose, or 2 doses of HBIG,* one as soon as possible after exposure and the second 1 month later.

For persons who refuse Hepatitis B Vaccine, a second dose of Hepatitis B Immune Globulin (Human) should be given 1 month after the first dose

The recommended post-exposure prophylaxis for a patient who has never been vaccinated against hepatitis B and has been exposed to hepatitis B is:

• Hepatitis B Immune Globulin (Human): a single dose of 0.06 mL/kg administered intramuscularly as soon as possible after exposure
• Hepatitis B Vaccine: initiate the vaccine series, with the first dose given within 1 week of exposure, and subsequent doses given 1 and 6 months later 2 2 2

From the Research

Post-Exposure Prophylaxis for Hepatitis B

• The recommended post-exposure prophylaxis for a patient who has never been vaccinated against hepatitis B and has been exposed to hepatitis B is a combination of hepatitis B immune globulin (HBIG) and hepatitis B vaccine 3, 4.
• HBIG provides immediate passive protection against infection with hepatitis B virus, while the hepatitis B vaccine provides active immunization 3.
• The principal indications for administration of HBIG include a single acute percutaneous exposure to hepatitis B virus, mucocutaneous exposure, unprotected sexual exposure, mother-to-infant transmission, prevention of re-infection after liver transplantation, non-responders to hepatitis B vaccine, and immunosuppressed patients 3.
• Studies have shown that the combination of HBIG and hepatitis B vaccine is efficacious for postexposure immunoprophylaxis of accidental infection, with a significantly lower frequency of hepatitis B virus infection compared to HBIG alone 4.

Administration of HBIG and Hepatitis B Vaccine

• HBIG and hepatitis B vaccine should be administered at different sites (limbs) to minimize interference with the immune response to the vaccine 5.
• Administration of HBIG with hepatitis B vaccine can delay and reduce responses to the vaccine, but this does not impact the long-term memory response to the vaccine 5.
• The Centers for Disease Control and Prevention (CDC) recommends hepatitis B vaccination for unvaccinated or incompletely vaccinated healthcare personnel with reasonably anticipated risk for blood or body fluid exposure, as well as postvaccination serologic testing to assess hepatitis B protection 6.

Importance of Vaccination

• Hepatitis B vaccination is essential for preventing transmission of the virus and its sequelae, including liver damage, cirrhosis, and hepatocellular carcinoma 7.
• The benefits of vaccination in preventing infection and its sequelae have been substantiated, and efforts are in place to reinforce screening, vaccination, and routine follow-up 7.