BACKGROUND: Hepatitis C virus (HCV) RNA was measured in commercial factor VIII concentrates, that is, antihemophilic factor (human) (AHF), to allow the retrospective evaluation of the effect of various virus‐ inactivation procedures. The impact on AHF of recent anti‐HCV screening of plasma was also investigated. STUDY DESIGN AND METHODS: A total of 183 lots of AHF made by six United States‐licensed manufacturers from anti‐HCV‐unscreened (1976–1991) or screened (1992–1993) plasma were examined. Detection and quantitation of HCV RNA were achieved by reverse transcription and nested polymerase chain reaction at limiting dilution. Anti‐HCV in AHF was also measured. RESULTS: Earlier AHF lots subjected to non‐virus‐inactivated treatment (36 lots), dry heat (11 lots), or heating in n‐heptane (4 lots) had relatively high levels of HCV RNA. Most (76%) wet‐heated lots prepared before 1992 contained HCV RNA. No HCV RNA was detected in lots purified by immunoaffinity and subsequently heated or solvent/detergent (S/D)‐treated. However, trace levels of HCV RNA were detected in S/D‐treated lots made by one of four manufacturers before 1992. Since the start of anti‐HCV plasma screening in 1992, 38 lots prepared by six manufacturers were negative for HCV RNA. Prevalence of anti‐HCV was also associated with earlier concentrates and with S/D‐treated lots from that single manufacturer. CONCLUSION: Anti‐HCV screening of plasma by manufacturers in conjunction with current virus‐inactivation procedures, wet‐heating or S/D treatment (either process with or without affinity purification), appears to reduce HCV RNA to undetectable levels in AHF.
Transfusion – Wiley
Published: Feb 1, 1995
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