An outbreak of acute hepatitis C among recipients of intravenous immunoglobulin

Background: An association between therapy with intravenous immunoglobulin (IVIG, Gammagard, Baxter Healthcare Corp) and acute hepatitis C (HCV) was reported by the manufacturer in 1994. Objective: We sought to describe those patients at risk at our institution who developed HCV infection after IVIG (Gammagard) treatment(s). Materials: An inception cohort study of patients with exposure to contaminated IVIG in a university tertiary care institution. Twenty-three patients received suspect IVIG and presented to be screened for HCV via ELISA II and polymerase chain reaction techniques. We describe the demographics and clinical characteristics of patients diagnosed with hepatitis C infection from IVIG. Results: Ten of 23 (44%) patients who had received immunoglobulin (2 g/kg) for neurologic or immunologic disorders and were tested for anti-HCV were positive. All were also HCV-RNA positive by polymerase chain reaction. None had other HCV risk factors; all but two had normal aminotransferases documented prior to therapy. The patients had received monthly therapy for periods ranging from 2 to 60 months. Four patients were asymptomatic and the others had mild symptoms. One patient spontaneously became PCR negative within 12 months after exposure. Conclusion: Patients who received intravenous immunoglobulin (Gammagard, Baxter Healthcare Corp) between March, 1993, and February, 1994, are at risk for acute hepatitis C. The initial sequellae appear to be mild and spontaneous remission is possible.