Cohort of hepatitis B research of Amsterdam

According to the report from the World Health Organization
(WHO) in 2009 worldwide 2 billion people are infected with the hepatitis B
virus (HBV) of which 350 million are chronically infected. Hepatitis B is also
responsible for 500,000 to 700,000 annual deaths. HBV is a DNA virus, a member
of the hepadna viruses of which 8 different genotypes exist.
Transmission of HBV occurs through blood-blood or sexual
contact in the Western world while perinatal transmission is the main cause of
transmission in Asia and Africa. After HBV infection, clinical manifestations
vary from an asymptomatic course to a pronounced jaundice. In contrast to
perinatal transmission where over 90% of the newborns become chronically
infected, acute HBV infection later in life results in a high likelihood of
spontaneous clearance. In chronically infected HBV patients over time the
immune system is responsible for progressive fibrosis of the liver that
eventually lead to other developing cirrhosis. If cirrhosis has been
established, there is an annual risk of developing hepatocellular carcinoma
(HCC) of 1.3 - 2.4%. The 5-year cumulative risk of developing HCC in cirrhotic
patients is 17% in East Asia and 10% in Western Europe
A number of studies have identified predictors for
progression to advanced fibrosis and occurrence of complications. A large
Taiwanese prospective cohort study of 3582 untreated HBV-infected patients
showed the serum hepatitis B viral load as a strong predictor of cirrhosis,
regardless of the HBV e-antigen status and serum alanine transaminase (ALT).
The cumulative incidence of cirrhosis ranged from 4.5% in patients with a viral
load below 300 copies / mL to 36.2% in patients with a viral load of 10x6
copies / mL or more.
It is unclear whether these data can be extrapolated to the
non-Asian population (Caucasians and Africans). First, there are geographical
differences in HBV genotype. In Asia, genotype B and C are mainly expressed,
while in Europe genotype A and D are mainly expressed. There are also
differences in habits or HLA expression that may lead to a difference in the
development of HBV-infected liver disease between Caucasians and Asians (and
Africans).
As a part of the HBV-infected population lives in Western
Europe and the United States, we believe it is important to investigate whether
there is an association between hepatitis B viral load and the development of
HBV-related complications in a non-Asian population.

The primary objective is to elucidate the question whether historic HBV viral
load (in samples taken from 1989 * 1996 during pregnancy) is associated with
the risk of HBV-related cirrhosis or mortality in a cohort of non-Asian
individuals with chronic hepatitis B infection.

Retrospective cohort study

To date, studies describing the association between the level of serum
hepatitis B viral load and the increased risk of secondary complication
development are lacking in non-Asian patients. This study gives important
information about the association between the serum hepatitis B viral load and
occurrence of secondary complications in a non-Asian patient population with
only a single venapunction and a non-invasive fibroscan. The benefit is not
only related to future subjects but also for patients who are participating in
this study.
Participation gives the patients more insight into their illness, their
current medical condition and possible secondary complications in relation to
the HBV infection. In a broader sense, when proven that high serum hepatitis B
viral load could lead to more secondary complications, this could have
important therapeutic and prognostic consequences in the management of
hepatitis B for that patient in the near future. Therefore, we consider the
risk to and burden for the subject low proportion to the potential value of the
research.