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• W2799572488 abstract "HEV-positive blood donations represent a relevant infection risk for immunosuppressed recipientsJournal of HepatologyVol. 69Issue 1PreviewHEV infections are present worldwide.1 Consumption of pork meat has been considered to be the major source of HEV Genotype (GT) 3 infections in Europe. In addition to zoonotic transmission, blood products were shown to be a potential source of acute and chronic HEV infection in industrialised countries.2,3 The anti-HEV seroprevalence rate in Europe, depicting the number of people previously exposed to HEV, varies largely depending on the region and the assay used.4 A high seroprevalence rate of 30% was found in healthy German individuals using the sensitive Wantai anti-HEV IgG assay. Full-Text PDF Hepatitis E virus (HEV) infection is probably the most frequent cause of acute viral hepatitis worldwide.[1]Hoofnagle J.H. Nelson K.E. Purcell R.H. Hepatitis E.N Engl J Med. 2012; 367: 1237-1244Crossref PubMed Scopus (390) Google Scholar In the past HEV was considered to be an infection of the developing world, where large outbreaks have been reported. These cases are caused by ingestion of fecally contaminated water and are related to HEV genotype 1 and 2. Increasing numbers of autochthonous cases in the developing world, caused mostly by HEV genotype 3 and 4, have been described over the last decade. Although the transmission routes are not completely understood, domesticated swine, wild boar and deer have been described as reservoirs for the zoonotic HEV genotype 3 and 4 strains and are a likely source of infection through the consumption of raw or undercooked meat, shellfish, vegetables and berries.[2]Donnelly M.C. Scobie L. Crossan C.L. Dalton H. Hayes P.C. Simpson K.J. Review article: hepatitis E-a concise review of virology, epidemiology, clinical presentation and therapy.Aliment Pharmacol Ther. 2017; 46: 126-141Crossref PubMed Scopus (59) Google Scholar In addition, the recognition that these HEV infections are an emerging threat for blood safety has major public health implications. In immunocompromised patients (organ transplant recipients, patients with hematologic malignancies undergoing chemotherapy, and those with HIV infections and low CD4 count) these infections (mostly genotype 3; isolated cases with genotype 4 and 7) can become chronic, leading to cirrhosis sometimes within a few years, contributing to the morbidity and mortality of an already vulnerable patient population. Finally, a number of extrahepatic, mostly neurologic manifestations have been associated with HEV genotype 1 and 3 infections (reviewed in1Hoofnagle J.H. Nelson K.E. Purcell R.H. Hepatitis E.N Engl J Med. 2012; 367: 1237-1244Crossref PubMed Scopus (390) Google Scholar, 2Donnelly M.C. Scobie L. Crossan C.L. Dalton H. Hayes P.C. Simpson K.J. Review article: hepatitis E-a concise review of virology, epidemiology, clinical presentation and therapy.Aliment Pharmacol Ther. 2017; 46: 126-141Crossref PubMed Scopus (59) Google Scholar, 3Nimgaonkar I. Ding Q. Schwartz R.E. Ploss A. Hepatitis E virus: advances and challenges.Nat Rev Gastroenterol Hepatol. 2018; 15: 96-110Crossref PubMed Scopus (142) Google Scholar, 4Dalton H.R. Kamar N. van Eijk J.J. McLean B.N. Cintas P. Bendall R.P. et al.Hepatitis E virus and neurological injury.Nat Rev Neurol. 2016; 12: 77-85Crossref PubMed Scopus (150) Google Scholar). The seroprevalence of HEV in Europe ranges between 0.6% and 86.4%, increasing with age but with no gender difference.5Hartl J. Otto B. Madden R.G. Webb G. Woolson K.L. Kriston L. et al.Hepatitis E seroprevalence in Europe: a meta-analysis.Viruses. 2016; 8: 211Crossref PubMed Scopus (159) Google Scholar, 6Mansuy J.M. Gallian P. Dimeglio C. Saune K. Arnaud C. Pelletier B. et al.A nationwide survey of hepatitis E viral infection in French blood donors.Hepatology. 2016; 63: 1145-1154Crossref PubMed Scopus (173) Google Scholar The prevalence rate heavily depends on the test assay and the geographical location. In European blood donor cohorts the prevalence has varied from 4.7% in Scotland to 86.4% in the south of France. Similarly, the number of HEV RNA-positive blood donations can be between 1 in 8,416 in Austria and as high as 1 in 726 in the Netherlands.2Donnelly M.C. Scobie L. Crossan C.L. Dalton H. Hayes P.C. Simpson K.J. Review article: hepatitis E-a concise review of virology, epidemiology, clinical presentation and therapy.Aliment Pharmacol Ther. 2017; 46: 126-141Crossref PubMed Scopus (59) Google Scholar, 7Domanovic D. Tedder R. Blumel J. Zaaijer H. Gallian P. Niederhauser C. et al.Hepatitis E and blood donation safety in selected European countries: a shift to screening?.Euro Surveill. 2017; 2230514Crossref PubMed Scopus (116) Google Scholar, 8Hogema B.M. Molier M. Sjerps M. de Waal M. van Swieten P. van de Laar T. et al.Incidence and duration of hepatitis E virus infection in Dutch blood donors.Transfusion. 2016; 56: 722-728Crossref PubMed Scopus (78) Google Scholar, 9Fischer C. Hofmann M. Danzer M. Hofer K. Kaar J. Gabriel C. Seroprevalence and Incidence of hepatitis E in blood donors in Upper Austria.PLoS One. 2015; 10e0119576Crossref PubMed Scopus (73) Google Scholar Whereas serological assays show a high variability, the currently available CE marked nucleic acid test (NAT) shows a similar performance and a high sensitivity with a lower limit of detection between 4.7 and 18.6 IU/ml.[10]Dreier J. Knabbe C. Vollmer T. Transfusion-transmitted hepatitis E: NAT screening of blood donations and infectious dose.Front Med. 2018; 5: 5Crossref PubMed Scopus (43) Google Scholar Transmission has been described for red blood cells, platelet preparations, pooled granulocytes and fresh frozen plasma, however not for plasma-derived products such as coagulation factors. The infection rate of recipients receiving blood products from HEV RNA-positive donors is around 42–50%.11Hewitt P.E. Ijaz S. Brailsford S.R. Brett R. Dicks S. Haywood B. et al.Hepatitis E virus in blood components: a prevalence and transmission study in southeast England.Lancet. 2014; 384: 1766-1773Abstract Full Text Full Text PDF PubMed Scopus (384) Google Scholar, 12Satake M. Matsubayashi K. Hoshi Y. Taira R. Furui Y. Kokudo N. et al.Unique clinical courses of transfusion-transmitted hepatitis E in patients with immunosuppression.Transfusion. 2017; 57: 280-288Crossref PubMed Scopus (46) Google Scholar Apart from the donor viral load, transmission is also influenced by the volume of plasma contained in the final blood product. The transmission rate is higher for fresh frozen plasma (100%) than for platelets (50%) and red blood cells (25%).[11]Hewitt P.E. Ijaz S. Brailsford S.R. Brett R. Dicks S. Haywood B. et al.Hepatitis E virus in blood components: a prevalence and transmission study in southeast England.Lancet. 2014; 384: 1766-1773Abstract Full Text Full Text PDF PubMed Scopus (384) Google Scholar The minimum infectious dose ranges somewhere between 7.0 × 103 and 3.6 × 104 IU HEV RNA.10Dreier J. Knabbe C. Vollmer T. Transfusion-transmitted hepatitis E: NAT screening of blood donations and infectious dose.Front Med. 2018; 5: 5Crossref PubMed Scopus (43) Google Scholar, 11Hewitt P.E. Ijaz S. Brailsford S.R. Brett R. Dicks S. Haywood B. et al.Hepatitis E virus in blood components: a prevalence and transmission study in southeast England.Lancet. 2014; 384: 1766-1773Abstract Full Text Full Text PDF PubMed Scopus (384) Google Scholar, 12Satake M. Matsubayashi K. Hoshi Y. Taira R. Furui Y. Kokudo N. et al.Unique clinical courses of transfusion-transmitted hepatitis E in patients with immunosuppression.Transfusion. 2017; 57: 280-288Crossref PubMed Scopus (46) Google Scholar It is unclear if the presence of specific antibodies in the donor or the recipient impacts on the transmission risk. In a subsequent analysis of the study by Hewitt et al., no impact of donor antibody status on the transmission risk was observed.[13]Tedder R.S. Ijaz S. Kitchen A. Ushiro-Lumb I. Tettmar K.I. Hewitt P. et al.Hepatitis E risks: pigs or blood-that is the question.Transfusion. 2017; 57: 267-272Crossref PubMed Scopus (57) Google Scholar Conversely, it is documented that immunocompetent and immunocompromised patients can be reinfected despite the presence of anti-HEV antibodies.14Abravanel F. Lhomme S. Chapuy-Regaud S. Mansuy J.M. Muscari F. Sallusto F. et al.Hepatitis E virus reinfections in solid-organ-transplant recipients can evolve into chronic infections.J Infect Dis. 2014; 209: 1900-1906Crossref PubMed Scopus (111) Google Scholar, 15Servant-Delmas A. Abravanel F. Lefrere J.J. Lionnet F. Hamon C. Izopet J. et al.New insights into the natural history of hepatitis E virus infection through a longitudinal study of multitransfused immunocompetent patients in France.J Viral Hepat. 2016; 23: 569-575Crossref PubMed Scopus (18) Google Scholar In this issue of the Journal, Westhölter et al. report the result of a prospective blood donor screening study in pools of 24 donations over an eight-month period including 18,714 donors.[16]Westholter D. Hiller J. Denzer U. Polywka S. Ayuk F. Rybczynski M. et al.HEV positive blood donations represent a relevant infection risk for immunosuppressed recipients.J Hepatol. 2018; 69: 36-42Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar The authors identified 23 HEV RNA-positive blood donors, corresponding to a prevalence of one positive donor per 815 donations. Only four of the 23 viremic donors tested positive for anti-HEV IgG and/or IgM antibodies and only three showed elevated aminotransferases. In symptomatic cases HEV RNA became rapidly negative, whereas in three asymptomatic donors viremia lasted for more than three months, and in one even more than four months. This is considerably longer compared to similar studies8Hogema B.M. Molier M. Sjerps M. de Waal M. van Swieten P. van de Laar T. et al.Incidence and duration of hepatitis E virus infection in Dutch blood donors.Transfusion. 2016; 56: 722-728Crossref PubMed Scopus (78) Google Scholar, 17Vollmer T. Diekmann J. Eberhardt M. Knabbe C. Dreier J. Hepatitis E in blood donors: investigation of the natural course of asymptomatic infection, Germany, 2011.Eurosurveillance. 2016; 21: 30332Crossref Scopus (36) Google Scholar, 18Tedder R.S. Tettmar K.I. Brailsford S.R. Said B. Ushiro-Lumb I. Kitchen A. et al.Virology, serology, and demography of hepatitis E viremic blood donors in South East England.Transfusion. 2016; 56: 1529-1536Crossref PubMed Scopus (34) Google Scholar and challenges the definition of chronic hepatitis E based on a viremia lasting more than three months.[19]Kamar N. Rostaing L. Legrand-Abravanel F. Izopet J. How should hepatitis E virus infection be defined in organ-transplant recipients?.Am J Transplant. 2013; 13: 1935-1936Crossref PubMed Scopus (93) Google Scholar Retrospective testing of stored samples from all positive donors revealed that four already tested positive in previous samples, leading to transfusion of HEV RNA positive blood products to 14 recipients. Two of these tested positive for HEV RNA; one died from acute-on-chronic liver failure and one developed acute, self-limited hepatitis E. In many of the others HEV infection could not be thoroughly investigated because of the severity of the underlying disease. Three of these four donors previously tested negative in pools of 24 donations, and only individual testing confirmed HEV RNA positivity. Risk factors for HEV RNA positivity were evaluated by a questionnaire: 18/23 (78%) participated and their results were compared to 256 unselected blood donors. Both cohorts were comparable in terms of age and sex. Eating pork meat was very common in both cohorts (89% and 87%, respectively) but the consumption of raw pork tartare was significantly more common in the HEV RNA-positive donors (67% vs. 35%, p = 0.01). Interestingly one blood donor couple ate raw pork liver four weeks before donating blood. Analysis of this liver revealed positive HEV RNA. This study adds to the discussion about implementing HEV RNA testing of blood donors, either universally or selectively for high-risk recipients. This discussion is fuelled by the changing epidemiology of HEV in Europe, with increasing numbers of HEV RNA-positive blood donors, now approaching prevalence rates below 1 per 1,000 donations, as in the study by Westhölter et al. Whereas most infected persons experience a mild, self-limiting disease course, vulnerable groups of patients are prone to develop chronic infection, which might rapidly progress to liver cirrhosis and death, or acute-on chronic liver failure, as pointed out in the study under discussion. Many patients receiving blood products today are in one way or the other immunosuppressed and are therefore prone to develop relevant complications if they acquire an HEV infection through blood products. Based on these data, several European countries (e.g. Ireland, the Netherlands, UK and France) have already begun molecular screening of blood donations for HEV RNA in different formats (individual donation or minipools). Many other countries are currently evaluating the introduction of HEV RNA screening and only Denmark opted against it (Fig. 1).[6]Mansuy J.M. Gallian P. Dimeglio C. Saune K. Arnaud C. Pelletier B. et al.A nationwide survey of hepatitis E viral infection in French blood donors.Hepatology. 2016; 63: 1145-1154Crossref PubMed Scopus (173) Google Scholar Blood donor screening is one option to increase the safety of blood products. However, it does not eliminate the risk of acquiring infections through consumption of contaminated food products. Other options, such as removing donors at risk of acquiring HEV, restricting donation to donors immune to HEV, pathogen reduction or immunizing patients at risk are currently not feasible. As the risk population for HEV is well defined, selective screening is a possibility and has been tried in the UK. The technical complexity and cost of selective screening led to the recent recommendation to change to a universal screening strategy.[7]Domanovic D. Tedder R. Blumel J. Zaaijer H. Gallian P. Niederhauser C. et al.Hepatitis E and blood donation safety in selected European countries: a shift to screening?.Euro Surveill. 2017; 2230514Crossref PubMed Scopus (116) Google Scholar Another unresolved issue is how to screen: As pointed out by the study of Westhölter et al., screening in pools of 24 can reduce the number of positive donations (transfusion of 63 positive blood products was prevented), while at the same time three positive donors were missed, leading to the transfusion of HEV RNA-positive blood products into five recipients. Most infections are prevented by individual testing but this strategy is associated with the highest testing cost, as shown in the cost-effectiveness study by de Vos et al.[20]de Vos A.S. Janssen M.P. Zaaijer H.L. Hogema B.M. Cost-effectiveness of the screening of blood donations for hepatitis E virus in the Netherlands.Transfusion. 2017; 57: 258-266Crossref PubMed Scopus (35) Google Scholar Therefore, the optimal pool size in terms of safety and cost needs to be determined in future studies. Although the temporal relationship between transfusion and detection of HEV RNA is striking, formal proof with sequence comparisons between donor and recipient are only exceptionally provided21Huzly D. Umhau M. Bettinger D. Cathomen T. Emmerich F. Hasselblatt P. et al.Transfusion-transmitted hepatitis E in Germany, 2013.Euro Surveill. 2014; 19: 20812Crossref PubMed Scopus (74) Google Scholar, 22Lhomme S. Bardiaux L. Abravanel F. Gallian P. Kamar N. Izopet J. Hepatitis E virus infection in solid organ transplant recipients, France.Emerg Infect Dis. 2017; 23: 353-356Crossref PubMed Scopus (22) Google Scholar and were also not available in the study by Westhölter et al. This is important, as the more relevant source of infection is dietary exposure to food products, as nicely shown by Lhomme et al.[22]Lhomme S. Bardiaux L. Abravanel F. Gallian P. Kamar N. Izopet J. Hepatitis E virus infection in solid organ transplant recipients, France.Emerg Infect Dis. 2017; 23: 353-356Crossref PubMed Scopus (22) Google Scholar These authors analysed 60 HEV RNA-positive solid organ transplant (SOT) recipients; only seven of them received transfusions. Retrospective analysis of blood samples from all donors showed that only three patients received blood from HEV RNA-positive donors and four did not. Phylogenetic analysis unequivocally identified viremic donors as the source of infection in two patients (sequence identity >99.0%). In the third patient sequence identity was only 84.2%. This suggests that other infectious sources are more probable. Therefore, at most 3 our 60 HEV-infected SOT recipients acquired their infections through blood products. These findings are further supported by a modelling study by Tedder et al.[13]Tedder R.S. Ijaz S. Kitchen A. Ushiro-Lumb I. Tettmar K.I. Hewitt P. et al.Hepatitis E risks: pigs or blood-that is the question.Transfusion. 2017; 57: 267-272Crossref PubMed Scopus (57) Google Scholar These authors calculated that the risk of acquiring an HEV infection by transfusion only exceeds the annual dietary risk if more than 13 blood products are transfused. Therefore, in most patients the dietary source is the main risk factor for HEV infection. However, screening of blood products is the only intervention that can be implemented immediately and that can lead to a reduction of infections while at the same time eliminating the reputational risk for blood banks. This strategy is associated with considerable cost.[20]de Vos A.S. Janssen M.P. Zaaijer H.L. Hogema B.M. Cost-effectiveness of the screening of blood donations for hepatitis E virus in the Netherlands.Transfusion. 2017; 57: 258-266Crossref PubMed Scopus (35) Google Scholar Consequently, it is important that these interventions go hand in hand with reducing the dietary infection risk, otherwise this will be not more than a mere drop in the ocean. A first step would be to raise the awareness for the disease among physicians and patients. Secondly, transmission could be reduced by appropriately cooking pork meat, thereby reducing the viremic pool in the population. Finally, a vaccine for humans and/or lifestock would be the ultimate solution for preventing this disease. The authors received no financial support to produce this manuscript. The authors declare no conflicts of interest that pertain to this work. Please refer to the accompanying ICMJE disclosure forms for further details. The authors’ contributed equally to the editorial. 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• W2799572488 title "Hepatitis E blood donor screening – More than a mere drop in the ocean?" @default.
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