Abstract
Current epidemiologic and laboratory evidence suggests that immune globulin (IG) hepatitis B immune globulin (HBIG) and intraveous immune globulin (IVIG) carry no risk of transmitting human T-lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/LAV) infection. Safety questions arise from the concern that some immune globulins currently available were prepared from plasma pools that included units from donors who may have had HTLV-III/LAV viremia. However several studies have shown that recipients of HBIG and IG including lots known to be positive for antibody to HTLV-III/LAV did not seroconvert to antibody to HTLV-III/LAV positivity and have not developed signs and symptoms of acquired immunodeficiency syndrome (AIDS). No documented seroconversions have occurred in any of 183 health care workers who received IG or HBIG as prophylaxis against hepatitis B infection after exposure to blood or body fluids of AIDS patients. In another study 16 subjects were given HBIG that was strongly positive for HTLV-III/LAV antibodies. Low levels of passively acquired antibody were detected shortly after injection but reactivity did not persist beyond 6 months. Information regarding past therapy with immune globulins is available from 10227 of AIDS patients reported to Centers for Disease Control. The percentage of patients with no recognized risk factors for AIDS is not significantly different among those who received immune globulin (7/358 or 2%) than among those who did not (358/9869 or 4%). Also evaluated has been the basic fractionation processes used for production of immune globulins to determine their effectiveness in eliminating HTLV-III/LAV infectivity. The effectiveness of virus removal by partitioning and inactivation was calculated to be greater than 1 x 10 (15) IVIU/ml. It is concluded that current clinical indications for the use of immune globulins do not need to be changed on the basis of safety concerns.
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