Hepatitis E Clinical Trial
Official title:
Hepatitis E Virus Infection Among Patients With Acute Non-A, Non-B, Non-C Hepatitis in Al-Rajhy University Hospital for Liver
Hepatitis E is the fifth known human viral hepatitis and is probably the most common cause of
acute viral hepatitis in the world. The incidence of acute hepatitis E is estimated at 3
million human cases per year worldwide, with around 70,000 deaths. Most cases occur in
endemic countries, but the number of cases in low-endemic areas has increased. HEV
seroprevalence is high in developing countries, such as India and Southeast Asia, ranging
from 27-80%. Acute disease mortality is 1-4%, with risk being higher in pregnant women and
immunodeficient patients.
The four more prevalent genotypes are allocated into two groups. Epidemic hepatitis E
includes genotypes 1 and 2, which are considered human viruses and have caused the epidemics
of hepatitis. These forms are transmitted mainly by contaminated water and the fecal-oral
route. endemic hepatitis E includes genotypes 3 and 4, which are considered swine viruses
(common in domestic and wild pigs), capable of infecting humans as an accidental host and
therefore considered zoonotics.
The course and clinical presentation of hepatitis E is highly variable. The detailed
mechanisms that lead to the different clinical outcomes in hepatitis E are only partially
understood. It is known that both viral factors (genotype and dose of inoculum) and host
factors (presence of previous liver disease, pregnancy and distinct genetic polymorphisms)
determine the course of infection. In most cases, hepatitis E causes self-limited illness,
lasting from a few days to weeks, with an average of 4-6 weeks. However, in developed
countries it can cause chronic disease with rapid progression to cirrhosis, especially in
patients who are transplanted, have hematological malignancies requiring chemotherapy, or
have infection with HIV.
Hepatitis E is an underdiagnosed disease, partly due to the use of serological tests with low
sensitivity. Diagnosis can be made indirectly by detecting antibodies against HEV in the
serum, or directly by detecting the genome of the virus in blood or other body fluids. The
tests for anti-hepatitis E antibody screening are commercially available, but none of them
has been approved by the Food and Drug Administration (FDA). Unfortunately, the sensitivity
and specificity of these tests vary greatly and this could explain the discrepancies in rates
of anti-hepatitis E antibodies published for the various populations studied. The tests for
viral RNA in serum and feces are confirmatory, but still experimental.
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