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Hepatitis C virus RNA in factor VIII concentrates
1Laboratory of Plasma Derivatives, Food and Drug Administration, Rockville, Maryland.
Transfusion
|February 1, 1995
Summary
Hepatitis C virus (HCV) RNA is undetectable in antihemophilic factor (AHF) treated with modern virus-inactivation methods. Plasma screening for anti-HCV significantly improved AHF safety, eliminating detectable HCV RNA in treated lots.
Area of Science:
- Virology
- Hematology
- Public Health
Background:
- Hepatitis C virus (HCV) poses a risk in blood products.
- Factor VIII concentrates (AHF) historically carried HCV transmission risks.
Purpose of the Study:
- To evaluate the effectiveness of virus-inactivation procedures in AHF.
- To assess the impact of anti-HCV plasma screening on AHF safety.
Main Methods:
- Quantified HCV RNA in 183 AHF lots using RT-nested PCR.
- Examined AHF from 1976-1993, including screened and unscreened plasma.
- Measured anti-HCV antibodies in AHF concentrates.
Main Results:
- Older AHF lots with non-virus-inactivated or dry-heat treatments showed high HCV RNA levels.
- Wet-heated AHF before 1992 frequently contained HCV RNA.
- Immunoaffinity or S/D-treated AHF lacked detectable HCV RNA; trace levels found in some pre-1992 S/D lots.
- No HCV RNA detected in 38 AHF lots manufactured after anti-HCV plasma screening began in 1992.
Conclusions:
- Current virus-inactivation methods (wet-heating, S/D treatment) effectively eliminate HCV RNA in AHF.
- Anti-HCV plasma screening is crucial for ensuring HCV-undetectable AHF.
- Combined screening and inactivation significantly enhance AHF safety.