HEPATITIS-C VIRUS-INFECTION ASSOCIATED WITH ADMINISTRATION OF INTRAVENOUS IMMUNE GLOBULIN - A COHORT STUDY

Objective.-To determine the risk of and risk factors for hepatitis C v irus (HCV) infection among persons with immune deficiencies who had re ceived intravenous immune globulin (IGIV) between March 1993 and Febru ary 1994. Design.-Retrospective cohort study. Setting.-An immunology p rogram in a tertiary care hospital. Patients.-Of 341 persons who had r eceived IGIV between March 1, 1993, and February 22, 1994, 278 (82%) w ere enrolled. The mean age for the enrolled persons was 9 years, and 9 9% had primary immune deficiencies. Main Outcome Measures.-Evidence of HCV infection by detection in sera of antibody to HCV and/or HCV RNA by reverse transcriptase polymerase chain reaction. Results.-Twenty-th ree (11%) of 210 persons who received the IGIV Gammagard (Baxter Healt hcare Corporation, Deerfield, Ill) became infected compared with none of 52 persons who received exclusively other IGIV products (P=.01). In a multivariate analysis, HCV infection was associated only with Gamma gard produced from plasma screened by second-generation (multiantigen) anti-HCV tests (P=.03). Hepatitis C virus RNA was detected in Gammaga rd, and the risk of transmission to recipients increased with increasi ng quantity of HCV RNA infused, from 0 for those who received no HCV R NA-positive lots to 29% for the quartile of patients receiving the gre atest amount (P<.001). At least 9 different lots of Gammagard were req uired to account for all cases. Conclusion.-Gammagard was the only IGI V product implicated in the transmission of HCV. Infection was associa ted with higher quantities of HCV RNA in Gammagard produced from secon d-generation anti-HCV-screened plasma. Further studies are needed to d etermine reasons for the infectivity of Gammagard, and viral inactivat ion and removal steps are needed to ensure the safety of IGIV products .