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. The Ad Hoc Study Group of the Fondazione dell'Emofilia.
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.
Mariani
G
G
Department of Human Biopathology, University of Rome La Sapienza, Italy.
Di Paolantonio
T
T
Baklaya
R
R
Morfini
M
M
Mannucci
P M
PM
D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000494:pharmacology; D002648:Child; D002675:Child, Preschool; D003902:Detergents / Q000494:pharmacology; D005169:Factor VIII / Q000009:adverse effects*; D015658:HIV Infections / Q000517:prevention & control / Q000635:transmission; D006467:Hemophilia A / Q000628:therapy*; D035922:Hepatitis A Antibodies; D006508:Hepatitis Antibodies / Q000097:blood; D006509:Hepatitis B / Q000517:prevention & control / Q000635:transmission; D006526:Hepatitis C / Q000517:prevention & control / Q000635:transmission; D006507:Hepatovirus / Q000276:immunology; D006801:Humans; D007223:Infant; D008875:Middle Aged; D011446:Prospective Studies; D012016:Reference Values; D012997:Solvents / Q000494:pharmacology
D000998:Antiviral Agents; D003902:Detergents; D035922:Hepatitis A Antibodies; D006508:Hepatitis Antibodies; D012997:Solvents; D005169:Factor VIII; D000410:Alanine Transaminase