Grifols SA, Sant Cugat del Valles, Spain, Catalonia, Spain
Background/Case Studies: Hepatitis E virus (HEV) is the most common cause of acute viral hepatitis worldwide. Genotype (gt)3 and 4 infections are more prevalent in industrialized and high-income countries. Most HEV gt3 and gt4 infections are usually clinically silent but may cause symptomatic infections. HEV outcomes can be poor in high-risk patients, such as those with immunocompromise, whom may also develop chronic HEV infection. Aside from zoonotic transmission, transmission by transfusion is well-known. HEV screening in blood donations is not yet mandatory in most settings, but some countries/regions employ it. Consequently, tracing HEV in blood donations is increasing. Procleix UltrioPlex E assay combines screening for HIV-1/2, HBV, HCV and HEV, with 100% sensitivity. This study aims to assess the clinical impact of HEV screening in Catalonia with UltrioPlex E assay.
Study
Design/Methods: A de novo model of transfustion outcomes was developed in MS Excel. In this model individual donation (IVD) screening was compared to no screening. Within symptomatic HEV patients a distinction is made between hepatic and extrahepatic manifestations (figure 1). Hepatic manifestations can be acute or evolve to chronic hepatitis with cirrhosis. Cases of liver transplant and hepatocellular carcinoma can occur, and can progress to mortality. Published literature was used to identify the probability of the different events. The number of HEV infections, hepatic and extrahepatic symptomatic cases avoided, and the number of deaths avoided by performing IVD screening for 1 calendar year were calculated.
Results/Findings: In Catalonia, the risk of transfusing HEV RNA positive blood products is 0.036%. For the 85,000 Catalonian blood recipients following HEV screening for 1 calendar year, 92 HEV infections could be avoided. Screening avoids 2.66 and 1.69 neurological and hematological manifestations respectively. Moreover, 0.70 HEV related deaths and 1.93 cases of liver disease are avoided.
Conclusions: With the increasing prevalence of HEV RNA positive blood donations, more HEV infections can be avoided by adopting IVD for HEV. Currently, only clinical outcomes of the model are available and our next step will be to assess the cost-effectiveness of screening.
