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This
information sheet is for people who want to know more about the
ribavirin/interferon combination treatment for Hepatitis C. For
more information on the research behind the treatments, read the
detailed fact sheet, Ribavirin/Pegylated
Interferon Combination Therapy
What
does this treatment do?
The
aim of the treatment is to clear the hepatitis C virus from your
blood. Taking ribavirin and interferon or ribavirin and
pegylated interferon together is currently the most effective
treatment for hepatitis C.
When
to take treatment
At
present treatment is generally only available for people who have
abnormal ALT levels and moderate to severe inflammation and/or scarring
of their liver.
This information is found when the doctor does 2 tests:
1) Liver biopsy: A very small sample of the liver is taken and examined
under a microscope.
2) A simple blood test provides your ALT levels. These levels are
another way of showing how much your liver is inflamed.
The
amount of change in your liver is not necessarily determined by
how long you have had the hepatitis C virus.
What
is ribavirin?
Ribavirin
is a type of drug that works against some viruses. Ribavirin needs
to be taken with interferon to help it to work against the hepatitis
C virus. In this combined treatment ribavirin can improve people's
liver function tests (blood tests which show how well the liver
is working) and improve people's chances of clearing hepatitis C.
Ribavirin is taken in tablet form twice a day with food.
What
is interferon?
Interferons
are small proteins made by your body to help it fight viral infections
such as colds or hepatitis. Your body makes different types of interferons
to fight different infections.
There
are two types of artificially made interferons used to fight the
hepatitis C virus. They are standard interferon and pegylated interferon.
Standard interferon is given as an injection under the skin up to
three times a week.
What
is pegylated interferon?
Pegylated
interferon is made when a chemical called polyethylene glycol (PEG)
is attached to interferon. PEG helps the interferon to work in your
body for longer. It is given once a week as an injection just under
the skin.
What
does the latest research show?
Responding
to treatment
People who start treatment will be monitored to see how well the
treatment is working (how well they are responding to treatment).
There are a number of different strains or types (genotypes) of
the hepatitis C virus. People with these different genotypes may
respond differently to hepatitis C treatment.
Some
people are also more likely to clear the virus than others. These
are people who:
-
have genotype 2 or 3 (strains 2 or 3) of the virus
-
have lower levels of virus in their blood before they start taking
the treatments
-
are 40 years old or younger when they got the hepatitis C virus
-
are female
Table
1 - Treatment results
This
table shows the percentage of people from three different research
studies who appear to have cleared the virus from their blood
after using standard interferon and ribavirin or pegylated
interferon and ribavirin.
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Research
Study 1
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Research
Study 2
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Research
Study 3
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Standard
Interferon + ribavirin for 48 weeks
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Standard
Interferon + ribavirin for 24 weeks
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Standard
Interferon only for 48 weeks
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Pegylated
Interferon + ribavirin for 24 weeks
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Pegylated
Interferon + ribavirin
for 48 weeks
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Pegylated
Interferon + ribavirin
for 48 weeks
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Percentage
of people with Genotype 1 who appear to have cleared
the virus.
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31%
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18%
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11%
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41%
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51%
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54%
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Percentage
of people with Genotype 2 or 3 who appear to have cleared
the virus.
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64%
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64%
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33%
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78%
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73%
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89%
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Results
for people with severe liver scarring
Combination
therapy using pegylated interferon and ribavirin also appears to
work better than standard interferon and ribavirin for people with
severe scarring of the liver (cirrhosis). More research is occurring
in this area.
What
about the side-effects?
Most
people have some side effects when they take ribavirin and interferon.
One person could have a number of side-effects and another might
have very few or only mild side effects. It is important to contact
your liver clinic if you have any side effects.
Side-effects
of interferon
The
side effects for standard interferon and pegylated interferon are
the similar. Some common side-effects with interferon are:
-
feeling like you have the flu, such as headaches, muscle aches,
joint aches, fevers/chills and feeling sick
-
vomiting, loss of appetite, diarrhoea
-
dry skin, dry eyes, dry mouth, hair loss
-
less energy, feeling tired, difficulty sleeping
-
depression, mood swings, poor concentration, vagueness
-
A few people also have changes in their blood such as less white
blood cells and platelets (clotting blood cells) and thyroid
problems
Most
of these side-effects are not serious and will go away over time
once you stop taking the treatments. Some people have found that
by taking interferon at night, they sleep through the flu-like symptoms.
Side-effects
of ribavirin
Ribavirin
introduces other issues to the picture. Animal studies have found
that ribavirin may cause birth defects. Both women and men taking
ribavirin need to use effective birth control while they taking
the treatments and for six months afterwards. Men need to use condoms
during sex as ribavirin has been found in semen.
Ribavirin
may cause anaemia (a low number of red blood cells in the blood).
Anaemia can cause shortness of breath and feeling light headed and
tired. If this happens talk to your doctor as the amount of ribavirin
may need to be changed. People who have heart or lung disease or
who are over 60 years old may need to have extra tests before taking
ribavirin or may not be able to take it at all.
Ribavirin
can also cause symptoms such as nausea or vomiting so it should
be taken with meals.
Lifestyle
issues
If
you are interested in this combined treatment, it is important to
think about how it may affect your lifestyle and relationships.
Taking
interferon means giving yourself a small injection into the fat
on your stomach up to three times each week. This can hurt and cause
bruising.
Some
people find that, because of the side effects, taking these treatments
affects how they work. You may need to take time off work or talk
to your boss about changing your working hours for a time.
Many
people find it helps to talk about the treatments and their potential
side effects with the important people in their life. If side effects
do occur, then partners, family and friends feel better prepared
to provide support. You may wish to bring them along to the appointments
so they can get more information.
If
you are thinking about having children you may choose to have a
baby and then start the treatments. Or you might choose to take
the treatments, and then wait for 6 months after you have finished
before thinking about having a baby.
Thinking
about these issues and talking with your doctor is an important
part of preparing for treatment. You may also want to talk with
a counsellor. For contact details of a hepatitis C counsellor ring
your state Hepatitis C Council.
Where
to get these treatments
At
present in Victoria you can only get these treatments at specialist
liver clinics at major public hospitals.
References
Study
1: Poynard T, Marcellin P, Lee S, Niederau C, Minuk G, Ideo
G, Bain V, Heathcote J, Zeuzem S, Trepo C, Albrecht J, 1998, 'Randomised
trial of interferon alpha 2b for 48 weeks or 24 weeks versus interferon
alpha 2b plus placebo for 48 weeks for treatment of chronic infection
with hepatitis C virus' Lancet, vol. 352, p.1426-32
Study
2: Hadziyannis S et al 2002, 'Peginterferon alfa 2a (40KD) (PEGASYS)
in combination with ribavirin: efficacy and safety results from
a phase 111, randomised, double blind, multicentre study examining
effect and duration of treatment and RBV dose' European Association
for the Study of the Liver (EASL) Meeting
Study
3: Manns MP, McHutchison J, Gordon S et al 2000, 'PEG interferon
alpha 2b plus ribavirin for the treatment of chronic hepatitis C
- 24 week treatment analysis of a multicenter, multinational phase
III randomised controlled trial [abstract]' Hepatology, vol.
32, p.297A
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