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From: ironjustice on 20 Apr 2008 09:00
“Iron Reduction Therapy” along with interferon can result in an
effective cure rate in the area of 75-80%.

The New light of Myanmar
Saturday, 31 July , 2004

Hepatitis infections and Medical Research: a new cure to be available
soon

Hepatitis B virus infection and Hepatitis C virus infection are
important health problems worldwide, because these infections can
cause significant liver diseases that range from fulminating hepatitis
to hepatocellular carcinoma. World Health Organization (WHO) estimated
that 2,000 million people (one third of the worldÂ’s population) have
been infected with hepatitis B virus infection and 170 million persons
are chronically infected with hepatitis C virus infection. Hepatitis B
virus infection in the Asia-Pacific region is among the highest in the
world, and chronic hepatitis B virus infection in most of the
countries of the Asia-Pacific region is high (>10% prevalence).

In Myanmar, it has been estimated that 10% to 12% of the population
carry hepatitis B virus and approximately 3% carry hepatitis C virus
infection. Thus hepatitis infections are considered as priority health
problems and health authorities in Myanmar have taken various steps to
control and manage hepatitis infections.

Research is an essential component in the development of science. In
Myanmar, the importance of research is well recognized and the Head of
State had also clearly stated that emphasis is to be placed on
research and development in every field to improve human resource
development and material development. Since the early 70Â’s, DMR has
actively participated in activities towards the control of hepatitis
infections in Myanmar. Activities to assist in the diagnosis,
management and prevention of hepatitis infections have been carried
out and knowledge dissemination and technology transfer had been
carried out at various phases. The production of hepatitis B vaccine
in Myanmar is also in progress and in the stage of expansion.

Control of Hepatitis C infection

Hepatitis C virus infection can be a pernicious disease and is
responsible for considerable mortality and morbidity. More than 80%
individuals infected with the hepatitis C virus develop chronic
infection; the remaining I0-20% develops spontaneous clearance with
natural immunity. The majority of patients who develop chronic
hepatitis C virus infection ate asymptomatic; but 60-80% develops
inflammation of the liver as indicated by elevated liver enzymes. One-
third of chronically infected patients develop progressive liver
injury, fibrosis and cirrhosis over a period of 20-30 years, and 15%
develop liver cancer. Control of hepatitis C infection deem difficult,
as there is no effective vaccine against hepatitis C virus.

The problem of hepatitis C infection in Myanmar has been highlighted
and addressed by DMR. In a research study reported in 1998, DMR
clearly describes the risk of acquiring hepatitis C virus infection
through unscreened blood, which is apparent by the fact that in those
with history of blood transfusion, a significantly high prevalence of
hepatitis C virus infection (20%) had been observed. As the
association of hepatitis C virus infection and blood transfusion was
demonstrated, it is considered essential to procure steps for
obtaining hepatitis C test kits for screening of the virus in all
donated blood at blood banks in Myanmar. Research scientists from DMR
in collaboration with the Japanese scientists under “Control of
Hepatitis C in Myanmar Project” investigated on a modified, low cost,
accurate test kit that could be used to screen hepatitis C at blood
banks. After several experiments, the test kit is modified to increase
the capability 5 times. This has led to a dramatic reduction in the
cost of the test kits and the availability of hepatitis C test kits.

In May 2000, a milestone in the transfusion services of Myanmar has
been marked by the introduction of hepatitis C testing of donors at
blood banks in Yangon under the “Control of Hepatitis C in Myanmar”
project. During May 2000 to April 2004, a total of 154,161 blood
donors presenting at the National Blood Centre and 10 blood banks from
major hospitals in Yangon were tested using the modified test system.
The overall hepatitis C virus infection rate was found to be 2.6%.
Removal of unsafe blood donors from the donor pool has led to the
decline in the rate of transfusion associate hepatitis C virus
infection during the four-year project period. Detailed analysis
revealed that a downward trend was observed with the reduction in
hepatitis C virus infection rate to 1.9% from the initial rate of
3.1%. It can be predicted that the hepatitis C virus infection rate
among blood donors in Yangon could fall to less than 1.5% within the
next two years. In parallel with this programme, using advanced
molecular methods; DMR has successfully produced an ELISA system for
screening of hepatitis C virus infection. The technology was obtained
with the help of the scientists from the Centers for Disease Control,
United States of America. Steps are being carried out to transfer the
technology to major blood banks. As the annual blood transfusion rate
in Myanmar is over 200,000 units, implementation of donor screening
programme for hepatitis C infection will prevent 7,000 transfusion-
associated HCV infections annually.

Management of Hepatitis Infections

DMR has invested manpower and resources for control of hepatitis C
infection in Myanmar. We are now establishing techniques for
management of the unfortunate people who had unknowing contracted the
infection previously. With the overall hepatitis C virus infection
positive rate of 3% among blood donors, it can be roughly estimated
that 1.5 million cases of HCV infection exist in the current
population of 50 million Myanmar people. Management of these subjects
would require simple treatment regimens with minimal costs as the use
of anti-viral drugs with or without interferon therapy is very
expensive and is not affordable by most patients. This has called for
a simple and affordable treatment regimen for management of hepatitis
C infections.

Interferon has been claimed as an effective treatment for hepatitis C
infection. Management of hepatitis C infection using interferon
therapy is very expensive. The average six months of injections three
times a week for six months could cost millions of Kyats. This doesnÂ’t
include laboratory tests that are expensive and could varied from ten
thousand Kyats for basic tests to over one hundred thousand Kyats for
advance molecular studies. Moreover, the tests need to be carried Out
frequendy. During treatment, many patients also suffer side effects,
such as flu-like symptoms, a reduction in the number of disease
fighting white blood cells, and a decreased number of platelets in the
blood. Only 25 percent of hepatitis C virus infected patients respond
favorably without relapsing and up to half of the chronic hepatitis C
sufferers who had responded to interferon could have a relapse within
six months after stopping the treatment.

In recent years, due to the efforts of researchers throughout the
world, a new treatment regimen provides hope for millions of patients
suffering from hepatitis infections. A study published in the American
Journal of Gastroenterology, suggests that using “Iron Reduction
Therapy” along with interferon can result in an effective cure rate in
the area of 75-80%. Previously increases in levels of iron have been
noted with high frequencies in patients with chronic hepatitis C, and
the higher levels have, in general, been associated with lesser
likelihood of response to interferon therapy. Complete responders to
interferon have, on average, lower hepatic iron levels than do non-
complete responders. Excess iron could promote viral replication and
mutation and also increases free radicals in the host leading to
increasing liver damage. The role of iron influencing the natural
history of viral hepatitis was reported in a study more than 20 years
ago. Blumberg, an American scientist, had observed that patients with
hepatitis B viral infection with higher serum iron or ferritin levels
had greater likelihood of development of chronic infections than those
with lower levels, who more often resolved their infections
spontaneously.

Investigators throughout the world have reported on the beneficial
effect of phlebotomy, alone or in combination with interferon therapy.
Two recent multicenter, prospective, randomized trials have examined
iron reduction as an adjuvant therapy to interferon in previous
nonresponders and interferon-naive patients. Fontana from Michigan,
USA and his colleagues demonstrated that iron reduction improves
virological and histological response to short term interferon
therapy. Di Bisceglie and co-workers conducted clinical trial
comparing iron reduction by phlebotomy with iron reduction followed by
re-treatment with interferon in 96 patients with chronic hepatitis C
who had previously not responded to a course of interferon. In those
patients receiving phlebotomy plus interferon, less liver injury,
manifested by a decrease in serum liver enzyme activity and a slight
improvement in liver histopathology was found. Fargion and colleagues
from University of Milan, Northern Italy, reported that one unit
reduction of liver iron concentration was associated with having 3
times the odds of response. Fong TL and co-workers from The Liver Unit
of the University Of Southern California School Of Medicine, Los
Angeles, USA reported that iron depletion before interferon therapy
lead to a reduction in liver enzyme levels in 90% of patients with
hepatitis C infection.

In a very encouraging report by Hayashi and colleagues from Japan it
was found that iron reduction alone, by repeated phlebotomy, lowers
the liver enzyme (alanine aminotransferase) in chronic hepatitis C.
Investigators from Italy also demonstrated that phlebotomy reduces
liver enzymes levels in Italian subjects with hepatitis C infection.
It is now evident that minimum requirement for managing chronic
hepatitis C infection is good control of disease activity shown by
maintaining a low serum level of liver enzymes. Maintaining patients
at an iron deficient state for 5 years or more did not change the
staging of liver histology, in contrast with the advanced liver
histology in the control patients. The treatment has been initiated in
Japan and is approved in the United States as the first of the options
to interferon. Considering the therapeutic effects of iron removal on
both biochemical and histological parameters, the safety-proved
economical procedure might be recommended for patients as an option to
interferon.

The procedure involves collection of 200 ml (approximately one cup of
water) every week for 6 consecutive weeks to reduce the iron content
and followed by maintenance phase where phlebotomy of same amount was
carried Out every month. During the induction period 200 ml of
phlebotomy will be carried Out every 2 weeks during the first 24
weeks. During maintenance phase 200 ml of phlebotomy will be done
every 3 months for the next 12 months. A clinical trial is in progress
at the DMR with promising results. After completion of the trial the
standard operation procedures will be established. DMR is also
providing help to those who need phlebotomy. The procedure could be
adopted by various hospitals in Myanmar. The cost of such therapy is
very minimal and affordable by the majority of patients.

The beneficial effects of phlebotomy could be extended to extra-
hepatitis manifestations of hepatitis C infection. Hilzenrat and his
colleagues from Ben-Gurion University of the Negev, Israel,
demonstrated that phlebotomy improved extrahepatic manifestations of
HCV infection namely myalgia and seronegative nonerosive symmetrical
polyarthritis. Professor Okada from the Okayama University, Japan, a
famous pathologist, suggested that based on the pathophysiological
basis of the disease process, the benefits of phlebotomy could also be
applicable to patients with hepatitis B virus infection. Research work
is underway which could lead to particle application in the near
future.

Hepatitis B Vaccine

Two types of hepatitis B vaccine have been licensed in Myanmar. The
first type is manufactured from the plasma of chronically infected
persons and the other type is produced by recombinant DNA technology.
It is understandable that people are worried of the danger of viruses
contaminating vaccines produced from the plasma. Even some of the
health personnel think this way. We would like to emphasize that
plasma-derived hepatitis B are safe for use. Plasma derived vaccines
available internationally include Hepaccine-B produced by Chiel Jedang
Corporation (South Korea) and Hepavax B produced by Korea Green Cross.
These vaccines have been used in millions of people throughout the
world. DMR is also at present producing plasma derived hepatitis B
vaccine.

We would like to explain briefly the process of development of plasma
derived vaccines so that the readers could be assured of its safety
and potency. The development of plasma derived hepatitis B vaccine was
initiated at DMR in 1990 with funding by the United Nations
Development Programme and assisted by World Health Organisation. After
expert missions by world-renowned scientists and training of
laboratory technicians and scientists, DMR scientists using the New
York Blood Center method successfully developed it in 1996. The
vaccine was tested extensively for quality control according to the
requirement for biological and plasma derived hepatitis B vaccine as
recommended by WHO. They include sterility, general safety,
pyrogenicity, purity, potency, and specific activity tests. Advance
techniques such as electron microscopy and polymerase chain reaction
tests were also used. It has to passed through the Chimpanzee Safety
Tests carried out in Liberia under the sponsorship of New York Blood
Center. In 1994, the New York Blood Center, USA certified that the
vaccine and future lots of plasma derived vaccines produced at DMR is
safe for use in humans.

After several clinical trials, the safety and immunogenicity of the
DMR plasma derived hepatitis B vaccine was established and DMR is now
producing 100,000 paediatric doses annually and is distributing at a
very reasonable price which is less than one-fifth of the market
price. DMR has also established ‘the Vaccine and Diagnostic Clinic” to
cater hepatitis B testing, hepatitis B vaccination, and hepatitis B
antibody testing services. It is open office hours through out the
week. In line with the policy of the Ministry of Health, we are
providing quality services at an affordable price for the public. In
addition, counseling services are also provided. With the cetana, and
guidance of the Head of the State, DMR is building a hepatitis B
vaccine plant to produce recombinant and plasma-derived hepatitis B
vaccines to be incorporated into the Expanded Programme of
Immunization in Myanmar to ensure coverage throughout the country and
will establish a hepatitis B free generation of Myanmar people.

DMR have been conducting research on hepatitis infections for a long
time. It has identified hepatitis A and hepatitis E during outbreaks.
Since 1990, with the help of WHO and UNDP, DMR has initiated the pilot
project on production of plasma-derived hepatitis B vaccine. It was
successfully produced in 1993 and has satisfied the quality control
requirements of WHO. DMR has also sent scientists to Centers for
Diseases Control in Atlanta, USA and has studied the development of
test kits for detection of hepatitis C infection. It has now developed
the test kit and is in the process of technology transfer to
government hospitals and clinics. It will greatly reduce the valuable
foreign exchange.

The Vaccine and Diagnostic Clinic at DMR has been providing
vaccination and laboratory services to the people of Myanmar at
affordable prices to the people of Myanmar. We would like to provide
information that it has been upgraded to provide new inexpensive
methods of treatment to hepatitis patients in order to prevent the
consequences of hepatitis infections such as liver cirrhosis and liver
cancer and to achieve a healthy state of life.

Author : Dr Paing Soe (Department of Medical Reserach)


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Tom


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