Drug treatment for

chronic hepatitis B

Implementing NICE guidance

NICE technology appraisal guidance 96, 153, 154, 173

Updated 2009

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:

•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:

•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 surfaceantigen (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

• Peginterferon alfa-2a is recommended as an option for the initial treatment of adults with chronic hepatitis B (HBeAg-positive or HBeAg-negative).

• 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:

• 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:

• 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 HBeAg-positive 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:

•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)