The epidemiology of virus transmission by plasma derivatives: clinical studies verifying the lack of transmission of hepatitis B and C viruses and HIV type 1.
During the past 50 years, most US-licensed plasma derivatives have maintained an impressive record of not transmitting HBV, HCV, or HIV Albumin (50-year history) has never transmitted these viruses. PPF (40-year history) transmitted HBV on only one occasion, which was associated with a design flaw in one manufacturing plant. IGIM has never transmitted any of these viruses since the requirement of sensitive serologic screening tests for HBV (24 years). IGIV (17-year history) transmitted HCV in only one outbreak involving the product of one manufacturer. Even AHF and FIX have not transmitted these viruses since effective virus-inactivation processes in manufacturing were developed. In summary, there has been no transmission of HBV, HCV, or HIV by US-licensed plasma derivatives since the introduction of effective virus-inactivation procedures. This means, essentially, that there has been no transmission of these viruses since the end of 1987; the sole exception is IGIV, by which there has been no transmission since 1994.
Tabor
E
E
Office of Blood Research and Review, Food and Drug Administration, Bethesda, Maryland, USA.
D005260:Female; D015658:HIV Infections / Q000635:transmission; D006509:Hepatitis B / Q000097:blood / Q000635:transmission; D006526:Hepatitis C / Q000635:transmission; D006801:Humans; D010949:Plasma / Q000821:virology*; D011247:Pregnancy; D012709:Serum Albumin / Q000302:isolation & purification; D014777:Virus Diseases / Q000453:epidemiology* / Q000635:transmission*
D012709:Serum Albumin