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Strategies for the Prevention of Post-Transfusion Hepatitis PAUL D

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Strategies for the Prevention of Post-Transfusion Hepatitis PAUL D ANNALS OF CLINICAL AND LABORATORY SCIENCE, Vol. 14, No. 3 Copyright © 1984, Institute for Clinical Science, Inc. Strategies for the Prevention of Post-Transfusion Hepatitis PAUL D. MINTZ, M.D. Blood Bank and Transfusion Service, University of Virginia Medical Center, Charlottesville, VA 22908 ABSTRACT Hepatitis is a common and potentially serious adverse effect of blood transfusion. A large number of strategies have been developed or proposed to reduce the incidence of post-transfusion hepatitis (PTH). The education of physicians regarding the risks of hemotherapy and the judicious use of blood must be the cornerstone of any substantial reduction in PTH. The use of volunteer rather than paid donors is associated with a much reduced incidence of PTH. Deferral of donors implicated in PTH is also helpful. Other proposed strategies include donor alanine amino-trans- ferase levels, donor anti-HBc testing, the provision of immune globulin to recipients, and the inactivation, removal, or immune neutralization of the virus from blood products. In the absence of a blood substitute, au­ tologous transfusion is an excellent means of improving transfusion safety. The incidence of PTH type B should decrease as an increasing proportion of donors and recipients are immunized by vaccine and as increasingly sensitive tests for HBsAg become available. The development of a sero­ logic test and vaccine for non-A, non-B hepatitis would be outstanding accomplishments, but their absence underscores the need to pursue vig­ orously other means of reducing the incidence of the disease. Introduction from blood transfusion at all.49 In any event, efforts at reducing the incidence Post-transfusion hepatitis (PTH) de­ of PTH will be successful only if they are velops in approximately seven percent of directed at preventing the transmission the recipients of blood transfusions.1 of NANB hepatitis. Unfortunately, spon­ Non-A, non-B (NANB) hepatitis accounts taneous resolution of acute NANB hep­ for approximately 90 percent of these atitis fails to occur in as many as 60 per­ cases; type B hepatitis is responsible for cent of patients.812 The development of the remainder.138 Aach has estimated a chronic, asymptomatic infectious car­ that 230,000 new cases of NANB PTH rier state in association with the fact that may occur annually in the United States most patients who develop NANB hep­ alone.1 It has been suggested that pa­ atitis are never symptomatic or icteric tients with apparent PTH type B may in and never know that they have had the fact not have acquired their hepatitis disease creates a pool of apparently 198 0091-7370/84/0500-0198 $01.50 © Institute for Clinical Science, Inc. STRATEGIES TO REDUCE PTH 199 healthy blood donors capable of trans­ cent of apparently healthy blood donors. mitting NANB hepatitis. This report will These donors will want to know the sig­ review specific strategies that have been nificance of the abnormal result detected developed to try to reduce the incidence in their blood and what to do about it as of PTH. well as who will pay for a subsequent medical evaluation. In addition, the cost Alanine Amino-transferase Testing of performing the ALT determinations is of concern. One center that has per­ There have been two prospective formed such testing for more than two studies that have demonstrated an asso­ years calculates a cost of $1.22 per unit ciation between the risk of NANB PTH when considering the cost of both the and the serum alanine amino-transferase testing and the loss of income from dis­ (ALT) in a donor’s blood.2,6 The transfu­ carded blood.60 An ad hoc committee of sion-transmitted viruses study followed the American Association of Blood Banks 1,513 transfusion recipients for five (AABB) concluded that “at this time we years.2 The incidence of hepatitis was di­ do not advise routine donor testing for rectly correlated with the serum ALT ALT as a means for reducing the inci­ level in the blood donors. This relation­ dence of NANB hepatitis”.41 The con­ ship was observed among recipients of cerns specified included the fact that single or multiple transfusions of blood. ALT is not a specific test for NANB hep­ In fact, approximately 40 percent of the atitis, that no study has shown that the cases of NANB PTH were associated actual elimination of donors with ele­ with blood donor units that had an ALT vated levels of ALT in fact does reduce value equal to or greater than 45 IU per the incidence of elevated levels of ALT, 1. The data indicate that provision of “much less hepatitis”, post-transfusion, units with ALT values less than 45 IU the significance of elevations of ALT after per 1 could result in a reduction of transfusion are in fact unknown, that NANB PTH of 31 percent among multi­ there is insufficient information to estab­ donor recipients and 23 percent among lish what the cut off level for acceptable single unit recipients.3 However, approx­ donors should be, and that the effect of imately three percent of donors had ALT losing approximately three percent of levels above 45 IU and would have to be blood donors may seriously stress the na­ deferred. This study concluded that “the tion’s blood supply. high correlation between an elevated It is important to point out that the two ALT level and infectivity of transfused prospective studies reviewed also dem­ blood provides a compelling argument onstrated 70 percent of PTH would not that such screening should be insti­ be prevented by ALT testing and that tuted”. A second study by Alter et al6 transfusion of 70 percent of the donor also determined that the risk of PTH was blood with an elevated ALT level did not significantly associated with the level of result in PTH. These two numbers have donor ALT. They calculated that if do­ been likened to a 70 percent false-nega- nors with ALT levels greater than 53 IU tive rate and a 70 percent false-positive were excluded, 29 percent of the cases rate, respectively.21 of PTH could be prevented with the loss While some blood centers have of 1.6 percent of donor units. elected to initiate ALT testing and seek Several considerations have prevented answers to the issues raised with addi­ the widespread introduction of donor tional data,22,37,60 most blood collection ALT testing. First, such testing would centers have not initiated ALT testing of result in the rejection of two to three per­ donors. 200 M INTZ This issue is under active debate. This anti-HBc test clarifies the reason of the reviewer shares the concerns of the ad exclusion for the donor. Obviously, this hoc committee on ALT testing and finds testing could not be utilized without sur- it prudent not to initiate such testing of face-antigen testing as well since some all blood donors at this time. Those cen­ infectious donors may be surface-antigen ters currently performing ALT testing positive and negative for anti-HBc. may provide additional and compelling A recent survey of more than 20,000 evidence for its role in donor evaluation. volunteer blood donors found a preva­ lence of anti-HBc of 2.2 percent.36 How­ Anti-HBc Testing ever, more than 96 percent of donors positive for anti-HBc were also positive Blood donors capable of transmitting for anti-HBs. Thus, only 16 donors (0.08 hepatitis B may have anti-HBc as the percent) had anti-HBc in the absence of only serologic marker of this dis­ detectible HBsAg and anti-HBs. In ad­ ease. 23>29>40 The transfusion-transmitted dition, Tabor et al54 reported that 0.4 per­ viruses study noted that of the 15 pa­ cent of 1,086 volunteer blood donors tients who developed transfusion associ­ with no history of hepatitis had anti-HBc ated hepatitis B, eight had received at alone. Thus, screening volunteer blood least one unit of blood that was positive donors for anti-HBs as well as anti-HBc for anti-HBc.20 Assuming that these units would greatly reduce the number of do­ were responsible for causing the hepa­ nors eliminated since those who are pos­ titis B infection, then the majority of itive for both anti-HBs and anti-HBc are such infections might have been pre­ presumably not potentially infectious. vented by rejecting those donors positive Donors with an elevated ALT are for anti-HBc. However these units would more likely to have anti-HBs and, pre­ have to be replaced with anti-HBc neg­ sumably, anti-HBc.6 Therefore, the com­ ative units which also carry their own bined effects of ALT and anti-HBc hepatitis risk. testing would not be additive. Despite While the prevention of one half the the cost of testing and the exclusion of cases of PTH type B certainly seems de­ donors, careful consideration should be sirable, the fact that 90 percent of PTH given to this specific test that could pre­ is NANB means the overall effect would vent as many as one in six cases of PTH. be small unless anti-HBc testing could The Technical Manual of the AABB states also reduce the incidence of NANB PTH. that “routine testing of blood donors for Vyas and Perkins59 presented evidence anti-HBc is not recommended at this that the incidence of NANB PTH is time”.55 The expense of performing all higher in recipients of anti-HBc positive three serologic tests seems prohibitive. blood. Holland has calculated that per­ forming anti-HBc screening of blood do­ Immune Serum Globulin nors could result in a 12 percent reduc­ tion in the frequency NANB PTH.20 The value of immune globulin prepa­ Thus, he concluded that 17 percent of rations for the prevention of PTH is un­ cases of PTH might be prevented by the certain.
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