Hepatitis C infection and viremia in Dutch Hemophilia patients

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Abstract
Serum samples from 316 patients visiting the Dutch National Hemophilia Center were collected from 1979 to 1993 and stored at −30°C. Patients were placed into three different groups: (1) patients ever treated with large pool non‐hepatitis C virus (HCV)‐safe concentrate (n=179); (2) patients treated with cryoprecipitate (n = 125); and (3) patients treated exclusively with HCV‐save concentrate (n=12). In order to examine the prevalence of HCV infection in the different treatment groups serum samples were tested retrospectively for anti‐HCV antibody using second generation enzyme‐linked immunosorbent assay (ELISA) and recombinant immunoblot assay (RIBA‐2). Significant differences in the prevalence of HCV infection were found between these 3 groups (group 1: 99%, group 2: 66%, group 3: 0%). The safety of currently administered clotting products is demonstrated in 57 patients who remained without HCV markers between 1989 and 1993. To examine the natural course of HCV infection fresh‐frozen plasma samples were obtained recently from a subgroup of 277 hemophilia patients for HCV‐RNA detection by a well‐validated cDNA‐PCR assay. In contrast to other reports, no evidence was found for seronegative HCV carriers. None of 52 patients without anti‐HCV had detectable HCV‐RNA. Of 225 patients with anti‐HCV, 182 (81%) were HCV‐RNA positive. None of 39 anti‐HCV positive patients with a negative HCV‐RNA reaction had serum alanine aminotransferase (ALT) levels above 50 U/l, whereas 44% of HCV‐RNA positive patients had persistently elevated ALT levels above 50 U/l. These results indicate that 20% of hemophilia patients who have been infected with HCV in the past eliminated the virus or have viral replication below the detection limit of polymerase chain reaction (PCR) without biochemical evidence of liver damage.