Current status of solvent/detergent‐treated frozen plasma

Abstract

he Blood Products Advisory Committee of the Food and Drug Administration (FDA) recently recommended the approval of the use of solvent T and detergent treatment for fresh-frozen plasma (FFP). The FDA is expected to issue soon a license to VI.Technologies, Inc. (VITEX, New York, NY) to produce solventldetergent (SD)-treated plasma (SD plasma). Because an estimated 2 million units of plasma are transfused in the United States each year, the availability of an alternative blood component will likely have a significant impact on physician practices and on the supply of, and demand for, FFP This report reviews issues surrounding the development of SD technologies for use in virus inactivation, current clinical data relevant to the use of SD plasma, and answers to some commonly asked questions. The review is intended not to establish a standard or requirement for the use of FFP or SD plasma, but to provide background information for medical staffs as they consider transfusion alternatives. Development of guidelines or standards for voluntary compliance will require additional clinical data.Currently, most FFP is prepared in blood centers as a by-product of whole-blood processing, although FFP can also be prepared by plasmapheresis. FFP is a relatively safe biologic; its overall risk is estimated at 7.5 adverse events per 10,000 units transfused and 3.7 adverse events per 1,000 ABBREVIATIONS: AHF = anti-hemophilic factor; FDA = Food and Drug Administration; FFP = fresh-frozen plasma; HAV = hepatitis A virus; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; IU = International units; SD = solventldetergent (treatment); TNBP = tri(n-buty1)phosphate; lTP = thrombotic thrombocytopenic purpura.From the American Association of Blood Banks Ad Hoc Committee on SolventlDetergent-Treated Plasma.

United States thrombotic thrombocytopenic purpura apheresis study group (US TTP ASG): Multicenter survey and retrospective analysis of current efficacy of therapeutic plasma exchange

“…Recently, licensed solvent detergent treated plasma (SD plasma) holds similar promise. SD plasma, like CPP, lacks the unusually large multimers of von Willebrand factor, which have been implicated in the pathophysiology of TTP [16].…”

Recessively inherited coagulation disorders

“…The most widely used method of virus inactivation is based upon the addition to pooled FFP of a solvent-detergent mixture that quenches the infectivity of enveloped viruses but preserves the activity of coagulation factors. 79 Another virucidal method such as photoinactivation in the presence of methylene blue 80 preserves the activity of coagulation factors, but clinical experience is limited. These products are available in several European countries but not in the United States.…”

Transfusion Medicine — Blood Conservation

“…Treatment of plasma with a solvent-detergent process provides a means to inactivate all viruses with lipid envelopes, including HIV and hepatitis B and C viruses. 191 The process, accomplished on a commercial scale by pooling plasma from 2500 donors, yields units of standard size (200 ml) that are refrozen for distribution. The cost of a 200-ml unit of pooled plasma treated with the solvent-detergent process is two to five times as high as the cost of a 250-ml unit of untreated plasma from a single donor.…”