Prospective study of the evaluation of hepatitis C virus infectivity in a high‐purity, solvent/detergent‐treated factor VIII concentrate: parallel evaluation of other markers for lipid‐enveloped and non‐lipid‐ enveloped viruses.

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Abstract
This prospective study was carried out with the aim of evaluating the efficacy of solvent/detergent inactivation of the hepatitis C virus (HCV) as applied to a chromatographic factor VIII concentrate. In parallel, the markers for other viruses, either lipid‐enveloped (human immunodeficiency virus types 1 and 2 [HIV‐1 and ‐2] and hepatitis B virus [HBV]) or non‐lipid‐enveloped viruses (such as B19 parvovirus and hepatitis A virus [HAV]) were evaluated. The study included 14 hemophilia centers, which enrolled 36 previously untreated patients (median age, 3 years; range, 1–56). The length of follow‐up was 12 months, during which HCV (first‐ and second‐generation assays and recombinant immunoblot assay), HIV‐1 and ‐2, HBV, HAV (IgG and IgM), and parvovirus (IgG and IgM) antibodies, as well as alanine aminotransferase values were evaluated. Thirty‐one patients were analyzable; none seroconverted for HCV, HBV, or HIV after exposure to a total of 165,000 IU of factor VIII (41 different lots). In one patient, alanine aminotransferase values rose to 167 mU per mL, 6 weeks after the first concentrate infusion, and this patient seroconverted for HAV 1 week later. Furthermore, 10 patients seroconverted for parvovirus during follow‐up. This study suggests that the solvent/detergent method of virus inactivation is efficient in relation to lipid‐enveloped blood‐ borne viruses but not in relation to non‐lipid‐enveloped viruses.