Type B Hepatitis after Needle-Stick Exposure: Prevention with Hepatitis B Immune Globulin
Final Report of the Veterans Administration Cooperative Study
- 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.; and
- D. S. ZIMMON, M.D.
Abstract
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.
Article and Author Information
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▸From the Veterans Administration Hospitals in Washington, D.C.; Hines, Illinois; Long Beach, California; San Juan, Puerto Rico; Durham, North Carolina; East Orange, New Jersey; Boston, Massachusetts; Miami, Florida; Richmond, Virginia; Pittsburgh, Pennsylvania; Manhattan, New York; and from the Georgetown and George Washington University Schools of Medicine; the Blood Bank Department and Laboratory of Infectious Diseases, National Institutes of Health, Bethesda, Maryland; the Molecular Anatomy Program, Oak Ridge National Laboratory, Rockville, Maryland; and The American National Red Cross Research Laboratory, Bethesda, Maryland.
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Grant Support: in part by NIAID Interagency Agreement No. A1-2002.
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▸Requests for reprints should be addressed to Leonard B. Seeff, M.D.; Veteran's Administration Hospital; 50 Irving Street NW; Washington, DC 20422.
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- Received September 2, 1977.
- Accepted November 17, 1977.
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