Type B hepatitis after needle-stick exposure: prevention with hepatitis B immune globulin. Final report of the Veterans Administration Cooperative Study

• Published in: Annals of internal medicine Vol. 88; no. 3; p. 285
• Main Authors: Seeff, L B, Wright, E C, Zimmerman, H J, Alter, H J, Dietz, A A, Felsher, B F, Finkelstein, J D, Garcia-Pont, P, Gerin, J L, Greenlee, H B, Hamilton, J, Holland, P V, Kaplan, P M, Kiernan, T, Koff, R S, Leevy, C M, McAuliffe, V J, Nath, N, Purcell, R H, Schiff, E R, Schwartz, C C, Tamburro, C H, Vlahcevic, Z, Zemel, R, Zimmon, D S
• Format: Journal Article
• Language: English
• Published: United States 01-03-1978
• Subjects: Adolescent; Adult; Aged; Child; Child, Preschool; Clinical Trials as Topic; DNA-Directed DNA Polymerase; Double-Blind Method; Female; Hepatitis B - prevention & control; Hepatitis B - transmission; Hepatitis B Antigens; Hepatitis B Surface Antigens; Humans; Immune Sera; Immunoglobulins - therapeutic use; Injections - adverse effects; Male; Middle Aged; Needles - adverse effects; Renal Dialysis; United States; United States Department of Veterans Affairs; United States
• ISSN: 0003-4819
• DOI: 10.7326/0003-4819-88-3-285

Hepatitis B immune globulin (HBIG) and immune serum globulin (ISG) were examined in a randomized, double-blind trial to assess their relative efficacies in preventing type B hepatitis after needle-stick exposure to hepatitis B surface antigen (HBsAG)-positive donors. Clinical hepatitis developed in 1.4% of HBIG and in 5.9% of ISG recipients (P = 0.016), and seroconversion (anti-HBs) occurred in 5.6% and 20.7% of them respectively (P less than 0.001). Mild and transient side-effects were noted in 3.0% of ISG and in 3.2% of HBIG recipients. Available donor sera were examined for DNA polymerase (DNAP) and e antigen and antibody (HBeAg; anti-HBE). Both DNAP and HBeAg showed a highly statistically significant correlation with the infectivity of HBsAg-positive donors. Hepatitis B immune globulin remained significantly superior to ISG in preventing type B hepatitis even when the analysis was confined to these two high-risk subgroups. The efficacy of ISG in preventing type B hepatitis cannot be ascertained because a true placebo group was not included.