Failure of Specific Immunotherapy in Fulminant Type B Hepatitis

doi:10.1059/0003-4819-86-3-272

Failure of Specific Immunotherapy in Fulminant Type B Hepatitis

ACUTE HEPATIC FAILURE STUDY GROUP

Abstract

Investigators at 30 centers evaluated an intravenous hepatitis B immune globulin preparation in the therapy of fulminant type B hepatitis. Patients with serum positive for hepatitis B surface antigen were treated at stage II to stage IV of hepatic encephalopathy. A central computer program randomized cases for treatment with hyperimmune globulin or albumin placebo. During the first 6 months, the dose of hepatitis B immune globulin was 1.32 g of immunoglobulin G protein; during the last 7 months, it was 5.28 g. Neither dose eliminated antigenemia. In the placebo group, death occurred in four of eight cases randomized at stage II, five of eight at stage III, and 10 of 12 at stage IV. In the group treated with hyperimmune globulin, death occurred in three of five patients randomized at stage II, seven of 12 at stage III, and six of eight at stage IV. The study, therefore, showed no benefit of treatment with exogenous antibody.

Article and Author Information

▸From the Acute Hepatic Failure Study Group; Los Angeles, California. See Acknowledgments section for a list of the participating investigators.
Participating investigators and their institutional affiliations during the study included the following: Dr. G. L. Gitnick, University of California, Los Angeles (seven cases); Dr. K. Akdamar, Tulane University (six cases); Dr. A. G. Redeker, University of Southern California (five cases); Dr. E. Schiff, University of Miami (five cases); Dr. H. J. Zimmerman, George Washington University (five cases); Drs. D. Gocke and T. Q. Morris, Columbia University (four cases); Dr. 1. M. Arias, Albert Einstein School of Medicine (three cases); Dr. J. T. Galambos, Emory University (three cases); Dr. K. A. Fawaz, Tufts University (three cases); Dr. R. Schmid, University of California, San Francisco (three cases); Drs. A. Passette and W. Volwiler, University of Washington (three cases); Dr. B. Combes, University of Texas Southwestern Medical School (two cases); Dr. C. M. Leevy, College of Medicine, New Jersey (two cases); Dr. H. R. Lesesne, University of North Carolina (two cases); Drs. W. P. Baldus, E. R. Dickson, D. McGill, and J. Thistle, Mayo Clinic (one case); Dr. M. Brown, University of Rochester (one case); Dr. T. E. Bynum, Baylor University (one case); Dr. B. F. Clowdus, Chicago Medical School and Dr. F. Steigman, University of Illinois (one case); Drs. A. M. Connell and S. J. Goldberg, University of Cincinnati (one case); Drs. K. S. Henley and H. Kawanishi, University of Michigan (one case); Drs. G. A. Marin, J. D. Ostrow, and R. D. Soloway, University of Pennsylvania (one case); Dr. D. J. Ritt, University of California, San Diego (one case); Dr. F. R. Simon, University of Colorado (one case); Dr. E. Winkelman, Cleveland Clinic (one case); Dr. R. D. Aach, Washington University; Dr. H. O. Conn, Yale University; Dr. M. Gold, University of Texas, San Antonio; Dr. T. Hersh, Brown University; F. L. Iber, University of Maryland; and Dr. F. Schaffner, Mt. Sinai School of Medicine.
The National Heart and Lung Institute (NHLI) Policy Board and Data Safety Monitoring Committee: included the following: Dr. T. C. Chalmers; Dr. M. Conrad; Ms. M. Fischer; Dr. W. Friedewald (Chairman, Data Safety Monitoring Committee); Dr. G. F. Grady; Rev. M. Hamilton; Dr. J. W. Mosley; Dr. A. M. Prince; and Dr. D. M. Surgenor (Chairman, Policy Board). The NHLI Representative was Dr. J. M. Stengle. The NHLI Project Officers were Drs. J. Roche and J. M. Weiler.
Consultants were Drs. G. A. Eddy, H. Popper, T. B. Reynolds, and J. T. Sgouris.
Grant support: by a contract (72-2905) of the National Heart and Lung Institute.
▸Requests for reprints should be addressed to James W. Mosley, M.D.; 2826 South Hope St.; Los Angeles, CA 90007.
- Received February 12, 1976.
- Accepted November 22, 1976.