Download Drug treatment for chronic hepatitis B: slide set

Drug treatment for
chronic hepatitis B
Implementing NICE guidance
Updated 2009
NICE technology appraisal guidance 96, 153, 154, 173
What this presentation covers
Background
Recommendations
Costs
Find out more
Background:
what the guidance covers
The clinical and cost effectiveness of the following for treating
chronic hepatitis B:
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adefovir dipivoxil (TA96)
peginterferon alfa-2a (TA96)
entecavir (TA153)
telbivudine (TA154)
tenofovir (TA173)
The technology appraisals are not interrelated.
Background: hepatitis B
Hepatitis B is an infection of the liver caused by the hepatitis B virus
(HBV).
Transmission mostly occurs through:
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blood to blood contact
sexual intercourse
perinatal transmission from mother to infant.
The majority of those infected during adulthood make a full recovery
and acquire immunity.
Infection is detected by the presence of hepatitis B surface
antigen (HBsAg) in the serum.
Background:
chronic hepatitis B
Chronic hepatitis B is defined as persistence of HBsAg for 6 months
or more after acute infection.
Active infection can be described as hepatitis B ‘e’ antigen
(HBeAg+) or HBeAg–.
Of those with acute hepatitis B:
• 2–10% of adults
• 50% of young children
• almost 100% of infected neonates
will develop chronic hepatitis B.
Background:
chronic hepatitis B epidemiology
World Health Organization estimates that over 350 million people worldwide
have chronic hepatitis B.
Department of Health estimates 180,000 people in the UK have chronic
hepatitis B.
7700 new cases of chronic hepatitis B in the UK each year.
Of these, ~300 cases infected within the UK, and the remainder of cases
infected while living abroad prior to arrival in the UK
Most reports of acute infection in the UK occur as a result of
intravenous drug use or sexual exposure.
Cases where infection occurred abroad (in areas of high prevalence)
frequently occur by transmission from mother to child.
Background:
who is the guidance for
Adults with chronic hepatitis B.
These recommendations do not apply to people who are also
infected with hepatitis C or D, or HIV.
Recommendations:
peginterferon alfa-2a
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Peginterferon alfa-2a is recommended as an option for the
initial treatment of adults with chronic hepatitis B (HBeAgpositive or HBeAg-negative).
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Drug treatment with peginterferon alfa-2a or adefovir
dipivoxil should be initiated only by an appropriately qualified
healthcare professional with expertise in the management of
viral hepatitis.
Recommendations:
adefovir dipivoxil
Adefovir dipivoxil is recommended as an option if:
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treatment with interferon alfa or peginterferon alfa-2a has
been unsuccessful, or
a relapse occurs after successful initial treatment, or
treatment with interferon alfa or peginterferon alfa-2a is
poorly tolerated or contraindicated.
Recommendations:
adefovir dipivoxil
Adefovir dipivoxil should not normally be given before treatment with
lamivudine.
It may be used either alone or in combination with lamivudine when:
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treatment with lamivudine has resulted in viral resistance, or
lamivudine resistance is likely to occur rapidly, and
development of lamivudine resistance is likely to have an
adverse outcome.
Recommendations: entecavir
• Entecavir is recommended as an option for the
treatment of people with chronic HBeAg-positive or
HBeAg-negative hepatitis B in whom antiviral
treatment is indicated.
Recommendations: telbivudine
• Telbivudine is not recommended for the treatment
of chronic hepatitis B.
• People currently receiving telbivudine should have
the option to continue therapy until they and their
clinicians consider it appropriate to stop.
Recommendations: tenofovir
• Tenofovir disoproxil is recommended as an option
for the treatment of people with chronic HBeAgpositive or HBeAg-negative hepatitis B in whom
antiviral treatment is indicated.
• This does NOT apply in patients who also have
Hep C, Hep D or HIV
Costs
• Adefovir dipivoxil and peginterferon alfa-2a cost:
£7.08 million per year
• Entecavir cost:
£1.04 million per year
• Telbivudine: not recommended
• Tenofovir disoproxil cost: unlikely to result in a
significant change in resource use
For discussion
What is our local epidemiology?
How are we recording and acting upon any use
of telbivudine?
What data is available to measure use of these
drugs locally?
Find out more
Visit www.nice.org.uk/TA096, www.nice.org.uk/TA153,
www.nice.org.uk/TA154 and www.nice.org.uk/TA173 for:
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Other guideline formats
Costing report and template (TA 153 and 154)
Analysis of cost impact (TA 96)
Costing statement (TA 173)
Audit support (TA 153 and 154)