AMERICAN
IOU Formctiy AMERICAN JOURNAL OF HYGIENE C 1978 by The Johns Hopkins University School of Hygiene and Public Health
VOL. 107
FEBRUAEY, 1978
NO. 2
Reviews and Commentary PASSIVE IMMUNIZATION AGAINST HEPATITIS B: A REVIEW OF RECENT STUDIES AND COMMENT ON CURRENT ASPECTS OF CONTROL JAMES E. MAYNARD1
Early attempts to use standard immunoglobulin (IG), also called immune serum globulin, in the passive prophylaxis of viral hepatitis revealed this material to be of little or no benefit in the prevention of post-transfusion hepatitis (1, 2). Based on early findings, passive immunization against hepatitis B was not generally recommended. As late as 1972, the Public Health Service Advisory Committee on Immunization Practices stated that IG should not be used for protection against post-transfusion hepatitis or administered routinely to persons exposed to hepatitis B (3). In 1976, the above committee, in a joint statement with the Committee on Viral Hepatitis of the National Academy of Sciences-National Research Council, modified the 1972 statement to indicate that standard IG containing some antibody (anti-HBs) to the surface antigens (HBsAg) of the hepatitis B virus (HBV) could be of value in prophylaxis of individ-
uals exposed to HBsAg positive blood through accidental ingestion or needle pun;ture (4). The committees went on to indicate that IG with high titers of antiHBs, hepatitis B immune globulin (HBIG), had been found to provide greater protection than IG with intermediate or low anti-HBs titers in some trial settings, and that licensure of such a product with specified guidelines for its use might be shortly anticipated. At the present time at least one manufacturer has been licensed to produce HBIG and the product is currently marketed with. Food and Drug Administration (FDA) approved package insert recommendation for use limited exclusively to prophylaxis of individuals exposed to HBsAg positive materials, such as blood, plasma, or serum, by accidental needle stick, mucous membrane contact (accidental splash), or oral ingestion (pipetting accident). The fact that this latter material is available in only limited supply and at an initial cost per dose approximately 10 times that of standard IG has important implications for the public health approach to efficient control of hepatitis B through passive prophylaxis.
IOU Formctiy AMERICAN JOURNAL OF HYGIENE C 1978 by The Johns Hopkins University School of Hygiene and Public Health
VOL. 107
FEBRUAEY, 1978
NO. 2
Reviews and Commentary PASSIVE IMMUNIZATION AGAINST HEPATITIS B: A REVIEW OF RECENT STUDIES AND COMMENT ON CURRENT ASPECTS OF CONTROL JAMES E. MAYNARD1
Early attempts to use standard immunoglobulin (IG), also called immune serum globulin, in the passive prophylaxis of viral hepatitis revealed this material to be of little or no benefit in the prevention of post-transfusion hepatitis (1, 2). Based on early findings, passive immunization against hepatitis B was not generally recommended. As late as 1972, the Public Health Service Advisory Committee on Immunization Practices stated that IG should not be used for protection against post-transfusion hepatitis or administered routinely to persons exposed to hepatitis B (3). In 1976, the above committee, in a joint statement with the Committee on Viral Hepatitis of the National Academy of Sciences-National Research Council, modified the 1972 statement to indicate that standard IG containing some antibody (anti-HBs) to the surface antigens (HBsAg) of the hepatitis B virus (HBV) could be of value in prophylaxis of individ-
uals exposed to HBsAg positive blood through accidental ingestion or needle pun;ture (4). The committees went on to indicate that IG with high titers of antiHBs, hepatitis B immune globulin (HBIG), had been found to provide greater protection than IG with intermediate or low anti-HBs titers in some trial settings, and that licensure of such a product with specified guidelines for its use might be shortly anticipated. At the present time at least one manufacturer has been licensed to produce HBIG and the product is currently marketed with. Food and Drug Administration (FDA) approved package insert recommendation for use limited exclusively to prophylaxis of individuals exposed to HBsAg positive materials, such as blood, plasma, or serum, by accidental needle stick, mucous membrane contact (accidental splash), or oral ingestion (pipetting accident). The fact that this latter material is available in only limited supply and at an initial cost per dose approximately 10 times that of standard IG has important implications for the public health approach to efficient control of hepatitis B through passive prophylaxis.
