Js. Bresee et al., HEPATITIS-C VIRUS-INFECTION ASSOCIATED WITH ADMINISTRATION OF INTRAVENOUS IMMUNE GLOBULIN - A COHORT STUDY, JAMA, the journal of the American Medical Association, 276(19), 1996, pp. 1563-1567
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
.