This study is designed to determine the frequency of hepatitis C virus (HCV) infection in Clinical Center patients who have received implicated lots of Baxter Gammagard(R) Immune Globulin Intravenous (Human) since September 1992. This product was voluntarily recalled by the manufacturer in February 1994 following identification of a possible association between HCV transmission and Gammagard(R). The purpose of this study is to assess whether HCV was transmitted by Gammagard(R) and to provide education and counseling to the Clinical Center patients who might have acquired HCV infection. Patients who may have received this product have been identified by several mechanisms: (l) a computerized search of patient records for the order code; (2) a review of Pharmacy IV cards; and (3) physician responses to a memo requesting help in identifying patients sent to credentialed physicians in March 1994. Many identified patients have immunodeficiencies; many are children. Participating patients have a blood sample drawn to test for biochemical and serologic markers of HCV infection: alanine aminotransferase (ALT), antibody to HCV (anti-HCV), and polymerase chain reaction (PCR) for HCV RNA. Patients are also asked to complete a brief questionnaire regarding risk factors for HCV infection and any clinical manifestations of hepatitis. If evidence suggests HCV infection, we attempt to obtain pre-treatment evaluations by asking the patients' attending physicians if stored sera predating the receipt of Gammagard(R) might be available for retrospective testing. Enrollment and testing have been completed on 129 patients; 12 were identified with evidence of HCV infection (PCR positive for HCV RNA). 11 of the 12 were found to be infected prior to implicated IVIG receipt and all have a history of receipt of blood or blood products. One HCV infected patient, who received a single Gammagard(R) infusion at NIH did not have a contemporaneous sample available for testing and the implicated IVIG can not be ruled out.
