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: (1) 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. Identified patients who enroll in this study will be asked to 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. Blood samples will be obtained at least 6 months following the last receipt of IVIG. Patients will also be asked to complete a brief questionnaire regarding risk factors for HCV infection and any clinical manifestations of hepatitis. If evidence suggests HCV infection, we will 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. Patient enrollment has just begun; only two patients have enrolled so far and testing has been completed on only one patient who demonstrated no serologic or viral RNA evidence of HCV infection.
