Immunoglobulin preparations from hepatitis C antibody-positive plasma donors: influence on diagnosis and risk of infection in heart transplant recipients.

Abstract

All heart transplant patients in our clinic received intravenous immunoglobulins as a prophylaxis against cytomegalovirus infections or reactivations. Serum was sampled from 160 heart transplant patients within 4 months after surgery. In 98 samples (61%) hepatitis C virus (HCV)-specific antibodies could be detected by a "second generation" enzyme immunoassay. Of these HCV antibody-positive patients 89 were tested for a second time. At this time, 5-11 months later, in 66 patients (74%) the HCV antibody had disappeared. In the 23 still positively reacting patients, immunoglobulins were given in the last 6 months before serum sampling. Nine commercial immunoglobulin preparations were tested for HCV-specific antibodies and the presence of HCV RNA. Seven preparations were anti-HCV positive with titres in the range of 64-256, whereas reverse transcription and polymerase chain reaction did not detect HCV RNA in any immunoglobulin preparation. Passive antibody transfer rather than a HCV infection is the cause of HCV antibody detection in our patients. The presence of HCV antibodies in high concentrations in commercial immunoglobulin preparations may only be explained by an extremely high proportion of anti-HCV-positive single donations in the plasma pools used for immunoglobulin production. The passive HCV antibody transmission prevents anti-HCV serological monitoring of patients treated with these preparations. Additionally, there are reports on the transmission of hepatitis non-A, non-B via immunoglobulin preparations. Therefore, we recommend an anti-HCV screening of plasma donors.