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Drug treatment for chronic hepatitis B

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.

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Drug treatment for chronic hepatitis B

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  1. Drug treatment for chronic hepatitis B Implementing NICE guidance Updated 2009 NICE technology appraisal guidance 96, 153, 154, 173

  2. What this presentation covers • Background • Recommendations • Costs • Find out more

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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

  15. 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?

  16. 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)

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