Hepatitis E. Virus: An Emerging
Disease Affecting Multiple Species

Patrick G. Halbur DVM, PhD
Department of Veterinary Diagnostic and Production Animal Medicine
College of Veterinary Medicine, Iowa State University

Xiang-Jin Meng MD, PhD
Center for Molecular Medicine and Infectious Diseases
College of Veterinary Medicine, Virginia Polytechnic and State University

Introduction
Human hepatitis E virus (human HEV) is the causative agent of acute non-A, non-B hepatitis in humans.[1]  HEV is a non-enveloped, single-stranded, positive sense RNA virus.  HEV is thought to be transmitted via the fecal-oral route.  Swine hepatitis E virus (swine HEV) was first detected in pigs in Illinois in 1997 and is closely related to two recent human HEV isolates (US-1 and US-2) identified in the United States shortly after the discovery of swine HEV.[2]  Swine HEV is now believed to be ubiquitous in the global swine population.[2,3] 

Our group experimentally confirmed cross species infection of HEV.  We demonstrated that swine HEV can infect rhesus monkeys and a chimpanzee, and the US-2 strain of human HEV can infect pigs.[3,4]  These findings suggested that pigs may be an animal reservoir for HEV and intensified the concern that HEV is a potential zoonotic or xenozoonotic agent.[5,6]  Serological surveys have confirmed that people with close contact to pigs (pig farmers, veterinarians, slaughter house workers) have a higher risk of HEV infection (7, 8, 18).  Pig strains are often homologous to human strains in the same area further suggesting the possibility of animal-to-human transmission.[3,6,7,8,16] 

Until recently, the impression that swine hepatitis E virus (HEV) is a zoonotic disease was based on the experimental, molecular virological, and epidemiological evidence summarized above.  Direct evidence of the transmission of swine HEV from pigs or other animal reservoirs to humans had not been reported.  In 2003 that changed.  Strong clinical evidence of transmission of HEV infection from pig livers to human patients was documented in people in Japan who intentionally consumed raw pig livers.  Based on genetic analysis, the HEV isolated from one patient was 100% identical to that of a swine HEV isolate discovered from a packaged pig liver available at grocery stores where the patients lived.[9]  Further evidence of the zoonotic potential of HEV was provided by results of an investigation of an outbreak of hepatitis in people in Japan who had consumed raw deer meat.  This epidemic involved two Japanese families that consumed raw meat of a wild-caught Japanese Sika deer.  HEV RNA was detected in the left-over portion of the frozen deer meat and it was genetically identical to the HEV isolated from the patients that had consumed the meat.[10]

It has now become very important that we understand as much as possible about HEV from both the veterinary and human health points of view.  This presentation is intended to review and update the audience on swine HEV research being conducted at Iowa State University College of Veterinary Medicine in collaboration with Dr. Xiang-Jin Meng’s group at the College of Veterinary Medicine at Virginia Polytechnic Institute and State University.

Comparative pathogenesis of infection of pigs with hepatitis E virus recovered from a pig and a human [4]
Three week-old, specific pathogen free (SPF) pigs were inoculated with hepatitis E virus (HEV) to evaluate the pathogenicity and determine the sites of viral replication.  Sixty pigs were randomly divided into three groups as follows, pigs in group #1 (n=19) served as uninoculated control, pigs in group #2 (n=20) were intravenously inoculated with a swine strain of HEV, pigs in group #3 (n=21) were intravenously inoculated with the US-2 strain of human HEV.  Two to four pigs from each group were necropsied at 3, 7, 14, 20, 27, and 55 days post-inoculation (DPI).  Three pigs from each group were monitored weekly by serum chemistry profiles (AST, GGT, SDH, and bilirubin) for evidence of liver damage.  Blood and fecal swabs were collected weekly throughout the experiment.  There was no evidence of clinical disease or significant elevation of liver serum chemistry profiles in any of the groups.  Hepatitis lesions were very mild and multifocal in group 1 pigs, mild-to-moderate in group 2 pigs, and moderate-to-severe in group 3 pigs.  Multifocal lymphoplasmacytic hepatitis was observed in 9/17, 15/18, and 16/19 of the pigs in groups 1-3, respectively.  Focal hepatocellular necrosis was observed in 5/17, 10/18, and 13/19 of the pigs in group 1-3, respectively.  Hepatic inflammation and hepatocellular necrosis peaked in severity at 20 DPI and was still moderately severe at 55 DPI in the group inoculated with human HEV (group 3).   Swine and human HEV differ in virulence and both induce subclinical, but morphologically discernable, hepatitis in experimentally-infected SPF pigs.  All HEV-inoculated pigs seroconverted to anti-HEV IgG, and remained positive for at least 2 months post inoculation.  The virus was present in feces, liver tissue, and bile of pigs in both HEV-inoculated groups.  The duration of virus shedding in feces was 3-4 weeks.  This work suggests that pig livers or cells from the livers of HEV-infected pigs may represent a risk for transmission of HEV from pigs to human xenograft recipients.  Since HEV was present in the feces of infected pigs, exposure to such feces poses a risk for transmission of HEV, and pigs could potentially be an animal reservoir for HEV infection.

Experimental infection of pregnant gilts with swine hepatitis E virus [11]
Human HEV has been reported to cause severe disease and mortality in pregnant women in underdeveloped countries.[1]  The objective of this work was to assess the pathogenicity of swine HEV in pregnant gilts and to assess the usefulness of the pregnant gilt model to study human HEV infection.  Twelve gilts were intravenously inoculated with swine HEV and six served as uninoculated controls.  Samples from gilts and their fetuses, and samples from suckling and growing pigs were tested for swine HEV RNA, anti-HEV antibodies, and liver chemistry profiles.  Pathological examination was performed on the gilts and their fetuses or offspring at 4 separate days post inoculation.  Hepatitis E virus-inoculated gilts became viremic, shed HEV RNA in feces, and developed anti-HEV antibodies.  There was no evidence of clinical disease or elevation of liver serum chemistry profiles in the gilts or their offspring.  Mild multifocal lymphohistiocytic hepatitis was observed in 4 of 12 HEV-inoculated gilts.  There was no significant effect of swine HEV on fetal size, fetal viability, or offspring birth weight or weight gain.  None of the fetal serum or tissue samples contained detectable HEV RNA.  The offspring of the gilts acquired anti-HEV passive antibodies but remained seronegative after the passive antibodies waned by 71 days of age.  Swine HEV infection induced subclinical hepatitis in 4 of 12 pregnant gilts but had no effect on the reproductive performance of the gilts, no effect on the fetuses, and no effect on the offspring.  Vertical transmission of swine HEV from dams to their fetuses or offspring did not occur.  Fulminant hepatitis associated with HEV infection in some pregnant women was not reproduced in pregnant gilts, hence pregnant swine may not be an ideal model for studying HEV-induced disease in humans.  

Use of a swine bioassay and a RT-PCR assay to assess the risk of transmission of swine hepatitis E virus in pigs [12]
This work was done to assess the risk of transmission of swine hepatitis E virus to naïve pigs with tissues or feces collected from pigs experimentally inoculated with swine HEV.  Seventy-five, 3-week-old pigs were randomly assigned to 24 groups of 3-4 pigs and inoculated with homogenates of tissues (liver, heart, pancreas, or skeletal muscle) or a suspension of feces from swine HEV-infected pigs collected at 3, 7, 14, 20, 27, or 55 days post inoculation (DPI).  Each inoculum was prepared as a 10% suspension (W/V) in PBS buffer and tested by a semi-quantitative RT-PCR for swine HEV RNA and by the swine bioassay.  The inoculation route was intravenous for liver, heart, and pancreas and via stomach tube for skeletal muscle and fecal suspension.  For positive controls, 3 groups of pigs were inoculated with a 104.5 PID50, approximately equivalent to 106 genome equivalent (GE)/ml, of swine HEV via oral drop, stomach tube, or intravenous route, respectively.  The liver homogenate inocula and feces collected at 3-7 DPI and 14-20 DPI were positive for swine HEV RNA by RT-PCR.  The pigs inoculated intravenously with liver homogenates collected at 3-7 DPI and 14-20 DPI developed anti-HEV antibodies and swine HEV RNA was detected in their sera.  Pigs inoculated intravenously with heart, intravenously with pancreas, or via stomach tube with skeletal muscle homogenates or fecal suspensions did not develop detectable viremia or anti-HEV antibodies.  Intravenous inoculation (with feces and liver tissue) was successful; however oral inoculation (with feces and muscle tissue) was not successful in transmission of HEV.   Feces and liver tissue were collected from the same pigs, and the liver (with a titer of 102 – 104 GE/ml) was determined to be infectious when inoculated intravenously, whereas the feces (with a titer of 103 GE/ml) were not infectious when inoculated orally.  The standard infectious pool (swine feces) of HEV with a titer of 106 GE/ml was not adequate to induce infection orally.  This suggests that the likelihood of transmitting HEV via consumption of pork from an HEV infected pig is minimal.  These findings indicate that there is a potential risk of transmission of swine HEV via liver tissues from infected pigs in the early stages (3-20 DPI) of infection but it is unlikely that pork meat poses a risk of HEV transmission unless the meat is contaminated with feces from HEV-infected pigs.  The results also suggest that HEV transmission via the fecal-oral route may require a higher dose compared to the experimental intravenous route of transmission.  The swine bioassay confirms that HEV detected in liver tissue is infectious and the RT-PCR assay is an excellent tool to detect HEV infection in pig tissues and feces.

Determination of the Presence and Infectivity of Swine Hepatitis E Virus (HEV) in Swine Manure Storage Facilities and Nearby Water Sources (Kasorndorkbua et al., submitted for publication)
We recently conducted a field investigation to determine the presence of swine HEV in pig feces, manure in different types of manure storage facilities, drinking water on pig farms, and nearby surface water sources.  Twenty eight Iowa farms with pig finishing facilities were visited.  Samples of  fresh feces (a pool of feces from 5 pigs per site) collected from the floor of the finishing barn, pig manure from pits and/or lagoons (when present on the site), drinking water from the pig barns, and upstream and downstream surface water from the nearest source was collected (if applicable) in the late summer and fall of 2002.  All samples were processed by appropriate methods as follows; 10% fecal suspension for fresh feces [4], ultracentrifugation for swine manure [13], and filtration (MD1 Virosorb® and filter housing, CUNO Inc., Meriden, CT) organic flocculation and centrifugal concentration (Centricon®, Millipore, Billerica, MA) from drinking water and surface water [14,15].  The HEV-containing manure or water samples were then subject to semi-quantitative RT-PCR assay to determine the HEV titer in GE/ml.  Swine HEV RNA was detected in 18 of 28 farms; in fresh feces collected from the floor of the barns on 7 of 28 farms; in manure collected from concrete holding pits on 15 of 22 farms; in manure collected from lagoons on 3 of 8 farms; in drinking water samples on 0/28 farms; in upstream surface water on 0 of 19 farms; in downstream surface water on 0/24 farms.  We are in the process of performing swine bioassays to determine the infectivity of the positive feces, pit manure, and lagoon manure samples.  The finding of swine HEV in feces and pig manure on several randomly chosen farms further confirms that swine HEV is widespread in pigs in Iowa.  The presence of HEV in pit/lagoon samples indicates that the virus is stable in pit manure and such manure may pose a risk as a direct source of human infection or potentially as a source of water contamination and subsequent infection of humans or other species.  However, we did not find evidence of HEV in drinking water or surface water on any of the farms and it remains to be determined if HEV detected in manure samples is viable and infectious to pigs, humans, or other species. 

Transmission routes of swine hepatitis E virus in pigs (19)
Human hepatitis E virus has long been considered to be fecal-orally transmitted.  It seems logical that swine HEV is similarly transmitted.  We have recently demonstrated that intravenous inoculation (with feces and liver tissue) was successful; however, oral inoculation (with feces and muscle tissue) was not successful in transmission of HEV.[12]  Transmission of HEV in humans by blood transfusions in endemic areas has been confirmed.[19]  Other possible routes of transmission of swine HEV have not been investigated.  This study was designed to further investigate fecal-oral transmission, transmission by direct contact, transmission in tonsillar and nasal and ocular secretions, and transmission by contaminated needles.  Three positive control pigs were infected intravenously with our infectious pool of swine HEV and served as the source of HEV inocula or exposure as follows.  The positive control pigs were snared and a swab was used to aggressively rub the palatine tonsilar surface, nasal mucosa, and conjunctiva.  The same procedure was done with those same swabs on naïve pigs (n=3) penned separately in another room.  The positive control pigs were injected in the neck with Mycoplasma hyopneumoniae vaccine using a 1-inch 18 gauge needle, and the same needle was used to inject pigs (n=3) penned separately in another room.  The third group (n=3, penned separately in another room) was orally inoculated with approximately 15 grams of freshly-collected pooled feces obtained from the three swine HEV-shedding positive control pigs.  All the inoculation procedures were performed for three consecutive days.  Three pigs were placed in the same pen with the positive control pigs to confirm that the virus shed by those positive controls was infectious and could be transmitted by direct contact.  Infection status was determined by detection of swine HEV RNA in feces and serum by RT-PCR and/or demonstration of anti-HEV IgG seroconversion by ELISA.  All positive control pigs shed the virus in feces but only 2 of 3 had detectable viremia.  The direct contact pigs all became infected.  None of the tonsil or nasal or conjunctival swabs from the positive control pigs contained detectable HEV RNA and the HEV-naïve pigs exposed to these swabs remained free of HEV.  One of 3 pigs in the fecal-oral exposure group shed the virus in feces at 12 days after exposure and the shedding persisted for two weeks and anti-HEV was detected in this pig.  None of the pigs injected with the “contaminated” needles became viremic or shed the virus in feces or developed anti-HEV antibodies.  The findings indicate that fecal-oral route is most likely the primary route of swine HEV transmission and it is less likely that swine HEV is transmitted via exposure to saliva or nasal or ocular secretions or injection with blood-contaminated needles.

Future Work in Progress
We have begun further work to better understand the survivability of HEV in different food processing and handling procedures and in different environmental and production management regimens.  We are also investigating whether pigs can replicate HEV from other species such as rats and chickens and deer.  We are also interested in better understanding the mechanism of HEV-induced hepatic lesions.  Work also needs to be done to determine if there is a synergistic effect of HEV with other common swine pathogens such as PRRS virus, circovirus, Salmonella sp. and others.

Summary
The recent cases of HEV in humans following consumption of raw pig livers provides strong evidence further supporting the hypothesis that swine HEV is a zoonotic disease and pigs are a reservoir for HEV infection of humans.  The primary source for swine HEV transmission is most likely feces shed from pigs infected with HEV.  There remains little doubt that consumption of pig livers, particularly raw or undercooked, can serve as a means for transmission of hepatitis E virus from pigs to humans.  Our results to date indicate no evidence of contamination of drinking water on swine farms or contamination of surface water near swine farms with HEV. 

References

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2.  Meng XJ, Purcell RH, Halbur PG,  et al.: 1997. A novel virus in swine is closely related to the human hepatitis E virus. Proc Natl Acad Sci USA. 94:9860-9865.

3.  Meng XJ: 2000.  Zoonotic and xenozoonotic risks of the hepatitis E virus.  Infect. Dis. Rev. 2:35-41.

4.  Halbur PG, Kasorndorkbua C, Gilbert C, et al.: 2001. Comparative pathogenesis of infection of pigs with hepatitis E viruses discovered from a pig and a human. J. Clin. Microbiol. 39:918-923.

5.  Meng XJ, Halbur PG, Shapiro MS, et al.: 1998. Genetic and experimental evidence for cross-species infection by swine hepatitis E virus. J. Virol. 72:9714-9721.

6.  Yoo D and Giulivi A: 2000.  Xenotransplantation and the potential risk of xenogenic transmission of porcine viruses. Can. J. Vet. Res. 64:193-203.

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9.  Yazaki Y, Mizuo H, Takahashi M, et al.: 2003. Sporadic acute or fulminant hepatitis E virus in Hokkaido, Japan, may be food-borne, as suggested by the presence of hepaitits E virus in pig liver as food. J. Gen. Viol. 84:2351-2357.

10.  Tei S, Kitajima N, Takahashi K, and Mishiro S: 2003. Zoonotic transmission of hepatitis E virus from deer to human beings. Lancet 362:371-373.

11.  Kasorndorkbua C, Thacker BJ, Halbur PG, et al.: 2003. Experimental infection of pregnant gilts with swine hepatitis E virus. Can. J. Vet. Res. 67:303-306, 2003.

12.  Kasorndorkbua C, Halbur PG, Thomas PJ, et al.: 2002. Use of a swine bioassay and a RT-PCR assay to assess the risk of transmission of swine hepatitis E virus in pigs. J. Virol. Methods 101:71-78.

13.  Pina S, Jofre J, Emerson SU, et al.: 1998. Characterization of a strain of infectious hepatitis E virus isolated from sewage in an area where hepatitis E virus is not endemic. Appl. Environ. Microbiol. 64:4485-4488.

14.  Environmental Protection Agency: 1990. Detection of enteric viruses. Standard Methods :87-102.

15.  Abbaszadegan M, Stewart P and LeChevallier M: 1999. A strategy for detection of viruses in ground water by PCR. Appl. Environ. Microbiol. 65:444-449.

16.  Banks M, Bendall R, Grierson S et al.:  2004. Human and porcine hepatitis E virus strains, United Kingdom.  Emerg. Infect. Dis. 10 (5):953-955.

17.  Nishizawa T, Takahashi M, Mizuo H, et al.: 2003. Characterization of Japanese swine and human hepatitis E virus isolates with 99% identity over the entire genome.  J. Gen. Virol. 84:1245-51.

18.  Siochu A, Froesner G., Tassis PD et al.: 2004. Forst report of the prevalence of anti-hepatitis E virus (anti-HEV) IgG in serum of blood donors, slaughtermen, and swine farmers in Greece.  In Proceeding of the 18th International Pig Veterinary Society Congress, Hamburg, Germany, Vol. 1. p367.

19. Kasorndorkbua C, Guenette DK, Huang FF, Thomas PJ, Meng XJ, Halbur PG: 2004.  Routes of transmission of swine hepatitis E virus in pigs.  J. of Clin. Microbiol., 42(11):5047-52.