Hepatitis B Immune Globulin (Human) products provide passive immunization for individuals exposed to the hepatitis B virus as evidenced by a reduction in the attack rate of hepatitis B following use.^6-9

Clinical studies conducted prior to 1983 with hepatitis B immune globulins similar to Nabi-HB^{TM 10,11} indicate the advantage of simultaneous administration of Hepatitis B Vaccine and Hepatitis B Immune Globulin (Human). The Centers for Disease Control and Prevention Advisory Committee on Immunization Practices (ACIP) advises that the combination prophylaxis be provided based upon the increased efficacy found with that regimen in neonates.¹² Cases of hepatitis B are rarely seen following exposure to HBV in persons with preexisting anti-HBs. However, no prospective studies have been performed on the efficacy of concurrent Hepatitis B Vaccine and Hepatitis B Immune Globulin (Human) administration following parenteral exposure, mucous membrane contact, or oral ingestion in adults.

Infants born to HBsAg-positive mothers are at risk of being infected with HBV and becoming chronic carriers.¹³ The risk is especially great if the mother is also HBeAg-positive.¹⁴ Studies conducted with hepatitis B immune globulins similar to Nabi-HB^TM indicated that for an infant with perinatal exposure to an HBsAg-positive and HBsAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at birth with the Hepatitis B Vaccine series started soon after birth is 85-98% effective in preventing development of the HBV carrier state.^15-17 Regimens involving either multiple doses of Hepatitis B Immune Globulin (Human) alone or the vaccine series alone have a 70-90% efficacy, while a single dose of Hepatitis B Immune Globulin (Human) alone has 50% efficacy.¹⁸

Since infants have close contact with primary caregivers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant less than 12 months of age with Hepatitis B Immune Globulin (Human) and Hepatitis B Vaccine is indicated if the mother or primary caregiver has acute HBV infection.¹⁹

Sexual partners of HBsAg-positive persons are at increased risk of acquiring HBV infection. A single dose of Hepatitis B Immune Globulin (Human) is 75% effective if administered within two weeks of the last sexual exposure to a person with acute hepatitis B.¹⁹

Pharmacokinetics

Pharmacokinetics trials²⁰ of Nabi-HB^TM,Hepatitis B Immune Globulin (Human), given intramuscularly to 48 healthy volunteers demonstrate pharmacokinetic parameters similar to those reported by Scheiermann and Kuwert.²¹ The half-life for Nabi-HB^TM was 24.8±5.6 days. The clearance rate was 0.433±0.144 L/day and the volume of distribution was 15.3±6.2L.

Maximum concentration of Nabi-HB^TM was reached in 6.6±3.0 days. The maximum concentration of anti-HBs achieved by Nabi-HB^TM was consistent with that of another licensed Hepatitis B Immune Globulin (Human) when compared in the same pharmacokinetics trial. Comparability of pharmacokinetics between Nabi-HB^TM and a commercially available hepatitis B immunoglobulin indicate that similar efficacy of Nabi-HB^TM should be inferred.

Bookmark this page: