L. B. SEEFF, M.D.; E. C. WRIGHT, M.P.H.; H. J. ZIMMERMAN, M.D.; H. J. ALTER, M.D.; A. A. DIETZ, Ph.D.; B. F. FELSHER, M.D.; J. D. FINKELSTEIN, M.D.; P. GARCIA-PONT, M.D.; J. L. GERIN, Ph.D.; H. B. GREENLEE, M.D.; J. HAMILTON, M.D.; P. V. HOLLAND, M.D.; P. M. KAPLAN, Ph.D.; T. KIERNAN, M.D.; R. S. KOFF, M.D.; C. M. LEEVY, M.D.; V. J. McAULIFFE, M.D.; N. NATH, Ph.D.; R. H. PURCELL, M.D.; E. R. SCHIFF, M.D.; C. C. SCHWARTZ, M.D.; C. H. TAMBURRO, M.D.; Z. VLAHCEVIC, M.D.; R. ZEMEL, M.D.; D. S. ZIMMON, M.D.
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 < 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.
SEEFF LB, WRIGHT EC, ZIMMERMAN HJ, ALTER HJ, DIETZ AA, FELSHER BF, et al. Type B Hepatitis after Needle-Stick Exposure: Prevention with Hepatitis B Immune Globulin: Final Report of the Veterans Administration Cooperative Study. Ann Intern Med. ;88:285–293. doi: 10.7326/0003-4819-88-3-285
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Published: Ann Intern Med. 1978;88(3):285-293.
Emergency Medicine, Gastroenterology/Hepatology, Liver Disease.
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