Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination: Recommendations of the ACIP APPENDIX A: Postexposure Prophylaxis for Hepatitis B

Adapted from: CDC. Protection against viral hepatitis: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1990;39(No. RR-2):17-22.

INTRODUCTION

Prophylactic treatment to prevent infection after exposure to HBV should be considered in the following situations: perinatal exposure of an infant born to an HBsAg-positive mother, inadvertent percutaneous or permucosal exposure to HBsAg-positive blood, sexual exposure to an HBsAg- positive person, and household exposure of an infant 12 months of age to a primary care-giver who has acute hepatitis B.

Various studies have established the relative efficacies of HBIG and/or hepatitis B vaccine in different exposure situations. For an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of HBIG at birth with the hepatitis B vaccine series started soon after birth is 85%-95% effective in preventing develop- ment of the HBV carrier state (A1-A3). Regimens involving either multiple doses of HBIG alone or the vaccine series alone have 70%-90% efficacy (A4,A5).

For inadvertent perrcutaneous exposure, only regimens including HBIG and/or immune globulin (IG) have been studied. A regimen of two doses of HBIG, one given after exposure and one a month later, is about 75% effective in preventing hepatitis B in this setting (A6,A7). For sexual exposure to a person with acute hepatitis B, a single dose of HBIG is 75% effective if administered within 2 weeks of last sexual exposure (A8). The efficacy of IG for postexposure prophylaxis is uncertain; IG no longer has a role in postexposure prophylaxis of hepatitis B because of the avail- ability of HBIG and the wider use of hepatitis B vaccine.

Recommendations on postexposure prophylaxis are based on available efficacy data and on the likelihood of future HBV exposure for the person requiring treatment. In all exposures, a regimen combining HBIG with hepatitis B vaccine will provide both short- and long-term protection, will be less costly than the two-dose HBIG treatment alone, and is the treatment of choice.

Acute Exposure to Blood that Contains (or Might Contain) HBsAg

For inadvertent percutaneous (needlestick, laceration, or bite) or permucosal (ocular or mucous-membrane) exposure to blood, the decision to provide prophylaxis must include consideration of several factors: a) whether the source of the blood is available; b) the HBsAg status of the source; and c) the hepatitis B vaccination and vaccine-response status of the exposed person. Such exposures usually affect persons for whom hepatitis B vaccine is recommended. For any exposure of a person not previously vaccinated, hepatitis B vaccination is recommended.

After any such exposure, a blood sample should be obtained from the person who was the source of the exposure and should be tested for HBsAg. The hepatitis B vaccination status and anti-HBs response status (if known) of the exposed person should be reviewed. The outline below and Table_A1 summarize prophylaxis for percutaneous or permucosal exposure to blood according to the HBsAg status of the source of exposure and the vaccination status and vaccine response of the exposed person. For greatest effectiveness, passive prophylaxis with HBIG, when indicated, should be administered as soon as possible after exposure since its value beyond 7 days after exposure is unclear.

1. Source of exposure known and HBsAg positive

1. Exposed person has not been vaccinated or has not completed vaccin- ation. Hepatitis B vaccination should be initiated. A single dose of HBIG (0.06 mL/kg) should be administered as soon as possible after exposure and within 24 hours, if possible. The first dose of hepatitis B vaccine should be administered intramuscularly at a separate site (deltoid for adults) and can be administered simul- taneously with HBIG or within 7 days of exposure; subsequent doses should be administered as recommended for the specific vaccine. If the exposed person has begun but has not completed vaccination, one dose of HBIG should be administered immediately and vaccination should be completed as scheduled.

2. Exposed person has already been vaccinated against hepatitis B, and anti-HBs response status is known. (1) If the exposed person is known to have had adequate response in

   the past, the anti-HBs level should be tested unless an adequate level has been demonstrated within the last 24 months. Although current data show that vaccine-induced protection does not decrease as antibody level wanes, most experts consider the following approach to be prudent: (a) If the anti-HBs level is adequate, no treatment is

   necessary. (b) If the anti-HBs level is inadequate, * a booster dose of

   hepatitis B vaccine should be administered. (2) If the exposed person is known not to have responded to the

   primary vaccine series, he or she should receive either a single dose of HBIG and a dose of hepatitis B vaccine as soon as possible after exposure, or two doses of HBIG (0.06 mL/kg), one as soon as possible after exposure and the second 1 month later. The latter treatment is preferred for those who have not responded to at least four doses of vaccine.

3. Exposed person has already been vaccinated against hepatitis B, and the anti-HBs response is unknown. The exposed person should be tested for anti-HBs. (1) If the exposed person has adequate antibody, no additional

   treatment is necessary. (2) If the exposed person has inadequate antibody on testing, one

   dose of HBIG (0.06 mL/kg) should be administered immediately and a standard booster dose of vaccine administered at a different site.

2. Source of exposure known and HBsAg-negative

1. Exposed person has not been vaccinated or has not completed vaccin- ation. If unvaccinated, the exposed person should be administered the first dose of hepatitis B vaccine within 7 days of exposure, and vaccination should be completed as recommended. If the exposed person has not completed vaccination, vaccination series should be completed as scheduled.

2. Exposed person has already been vaccinated against hepatitis B. No treatment is necessary.

3. Source of exposure unknown or not available for testing.

1. Exposed person has not been vaccinated or has not completed vaccin- ation. If unvaccinated, the exposed person should be administered the first dose of hepatitis B vaccine within 7 days of exposure and vaccination should be completed as recommended. If the exposed person has not completed vaccination, vaccination should be completed as scheduled.

2. Exposed person has already been vaccinated against hepatitis B, and anti-HBs response status is known. (1) If the exposed person is known to have had adequate response in

   the past, no treatment is necessary. (2) If the exposed person is known not to have responded to the

   vaccine, prophylaxis as described earlier in section 1.b.(2) under "Source of exposure known and HBsAg-positive" may be considered if the source of the exposure is known to be at high risk of HBV infection.

3. Exposed person has already been vaccinated against hepatitis B, and the anti-HBs response is unknown. The exposed person should be tested for anti-HBs. (1) If the exposed person has adequate anti-HBs, no treatment is

   necessary. (2) If the exposed person has inadequate anti-HBs, a standard

   booster dose of vaccine should be administered.

Sex Partners of Persons with Acute Hepatitis B Virus Infection

Sex partners of HBsAg-positive persons are at increased risk of acquiring HBV infection, and HBIG has been shown to be 75% effective in preventing such infections (A8). Because data are limited, the period after sexual exposure during which HBIG is effective is unknown, but extrapo- lation from other settings makes it unlikely that this period would exceed 14 days. Before treatment, testing sex partners for susceptibility is recommended if it does not delay treatment beyond 14 days after last exposure. Testing for anti-HBc is the most efficient prescreening procedure to use in this population.

All susceptible persons whose sex partners have acute hepatitis B infection should receive a single dose of HBIG (0.06 mL/kg) and should begin the hepatitis B vaccine series if prophylaxis can be started within 14 days of the last sexual contact or if sexual contact with the infected person will continue. Administering the vaccine with HBIG may improve the efficacy of postexposure treatment. The vaccine has the added advantage of conferring long-lasting protection.

An alternate treatment for persons who are not from a high-risk group for whom vaccine is routinely recommended and whose regular sex partners have acute HBV infection is to administer one dose of HBIG (without vaccine) and retest the sex partner for HBsAg 3 months later. No further treatment is necessary if the sex partner becomes HBsAg negative. If the sex partner remains HBsAg positive, a second dose of HBIG should be given and the hepatitis B vaccine series started.

Household Contacts of Persons with Acute Hepatitis B Virus Infection

Since infants have close contact with primary care-givers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophyl- axis of an infant less than 12 months of age with HBIG (0.5 mL) and hepatitis B vaccine is indicated if the mother or primary care-giver has acute HBV infection. Prophylaxis for other household contacts of persons with acute HBV infection is not indicated unless they have had identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Such exposures should be treated like sexual exposures. If the index patient becomes an HBV carrier, all household contacts should receive hepatitis B vaccine.

References

vaccine: efficacy with hepatitis B immune globulin in prevention of perinatal hepatitis B virus transmission. JAMA 1987;257:2612-6. A2. Beasley RP, Hwang L-Y, Lee G-C, et al. Prevention of perinatally trans-

mitted hepatitis B virus infections with hepatitis B immune globulin and hepatitis B vaccine. Lancet 1983;2:1099-102. A3. Stevens CE, Toy P, Tong MJ, et al. Perinatal hepatitis B virus trans-

mission in the United States: prevention by passive-active immuni- zation. JAMA 1985;253:1740-5. A4. Beasley RP, Hwang L-Y, Stevens CE, et al. Efficacy of hepatitis B

immune globulin for prevention of perinatal transmission of the hepatitis B virus carrier state: final report of a randomized double- blind, placebo-controlled trial. Hepatology 1983;3:135-41. A5. Xu Z-Y, Liu C-B, Francis DP, et al. Prevention of perinatal acquisition

of hepatitis B virus carriage using vaccine: preliminary report of a randomized, double-blind placebo-controlled and comparative trial. Pediatrics 1985;76:713-8. A6. Seeff LB, Wright EC, Zimmerman HJ, et al. Type B hepatitis after

needlestick exposure. Prevention with hepatitis B immune globulin: final report of the Veterans Administration Cooperative Study. Ann Intern Med 1978;88:285-93. A7. Grady GF, Lee VA, Prince AM, et al. Hepatitis B immune globulin for

accidental exposures among medical personnel: final report of a multi- center controlled trial. J Infect Dis 1978; 138:625-38. A8. Redeker AG, Mosley JW, Gocke DJ, McKee AP, Pollack W. Hepatitis B

immune globulin as a prophylactic measure for spouses exposed to acute type B hepatitis. N Engl J Med 1975;293:1055-9.

* An adequate antibody level is >=10 mIU/mL.

TABLE A1. Recommendations for hepatitis B prophylaxis following percutaneous exposure
========================================================================================================
                                Treatment when source is found to be
                        -----------------------------------------------------
                                                                                Unknown or
Exposed person          HBsAg positive                   HBsAg negative         not tested
------------------------------------------------------------------------------------------------------
Unvaccinated            Administer HBIG x 1 * and        Initiate hepatitis B   Initiate hepatitis B
                        initiate hepatitis B vaccine +   vaccine +              vaccine +

Previously vaccinated
  Known responder       Test exposed person              No treatment           No treatment
                        for anti-HBs
                        1. If adequate,
                           no treatment
                        2. If inadequate,
                           hepatitis B
                           vaccine booster dose

  Known non-            HBIG x 2 or                      No treatment           If known high-risk
    responder           HBIG x 1, plus 1 dose                                   source, may treat as
                        of hepatitis B vaccine                                  if source were
                                                                                HBsAg positive

  Response              Test exposed person              No treatment           Test exposed person
    unknown             for anti-HB &                                           for anti-HBs &
                        1. If inadequate                                        1. If inadequate,
                           HBIG x 1, plus hepatitis                                hepatitis B vaccine
                           B vaccine booster dose                                  booster dose
                        2. If adequate, no treatment                            2. If adequate,
                                                                                   no treatment
------------------------------------------------------------------------------------------------------
* Hepatitis B immune globulin (HBIG) dose 0.06 mL/kg intramuscularly.
+ Hepatitis B vaccine dose -- see Table 1.
& Adequate anti-HBs is >=10 milli-international units.
========================================================================================================

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