Antibody Against the Human Immunodeficiency Virus in Commercial Intravenous Gammaglobulin Preparations

In a 6-month study, antibody levels against the human immunodeficiency virus (HIV) were determined in intravenous gammaglobulin preparations and 45 serum samples from 20 patients on gammaglobulin therapy. All 10 lots of a reduced and alkylated preparation and 4 of 8 lots of a pH4/pepsin-treated preparation were seropositive by enzyme-linked immunosorbent assay (ELISA). By Western blot analysis, 8 of 10 lots of the reduced and alkylated preparation and 3 of 8 lots of the pH4/pepsin-treated preparation were positive. Before gammaglobulin infusion, 2 of 45 preinfusion samples were seropositive by ELISA but seronegative by Western blot. After infusion, 15 of 45 samples were seropositive by ELISA, and 8 had antibody against p24 by Western blot. Seropositivity persisted for less than 1 month. Cultures of HIV-positive intravenous gammaglobulin lots were negative for reverse transcriptase activity or viral antigen expression. These results suggest that current methods of preparation either exclude or inactivate HIV.