Regulatory Focus™ > News Articles > UK's NICE Releases Draft Guidance on Diagnosis and Treatment of Hepatitis B

UK's NICE Releases Draft Guidance on Diagnosis and Treatment of Hepatitis B

Posted 18 January 2013 | By Louise Zornoza

The UK's cost containment agency, the National Institute for Health and Clinical Excellence (NICE), has issued a draft guideline on the diagnosis and management of chronic hepatitis B in children, young people and adults, explaining that only pegylated interferon and nucleoside or nucleotide analogues have been cleared for use by the National Health Service (NHS).

The guideline, released for consultation on 17 January 2013, also noted that although substantial progress has been made in the treatment of chronic hepatitis B, there is anecdotal evidence of wide variation in prescribing practice with regard to initial choice of agents and duration of therapy.

The NICE guideline addresses where:

  • Children, young people and adults with chronic hepatitis B should be assessed;
  • Criteria for offering antiviral treatment; the efficacy, safety and cost effectiveness of currently available treatments;
  • Selection of first-line therapy; management of treatment failure or drug resistance;
  • Whether there is a role for combination therapy; and
  • When it is possible to stop treatment; and monitoring for treatment response, severity of fibrosis and development of primary liver cancer.

Among the hepatitis B antiviral treatments that have been subject to NICE technology appraisals are:

  • Tenofovir disoproxil (Gilead Sciences/Japan Tobacco's Viread);
  • Telbivudine (Novartis' Sebivo);
  • Entecavir (Baraclude, from Bristol-Myers Squibb);
  • Adefovir dipivoxil (Gilead's Preveon); and
  • Peginterferon alfa-2a (Genentech's Pegasys)

The reported incidence of chronic hepatitis B in the UK has risen sharply, from 435 new cases in 1990 to 1151 in 2003. However, the true incidence of the disease is likely to have been underestimated because in the first years after infection there are often few or no symptoms. The number of people in the UK with the condition may number 360,000, and more than 6500 people with chronic hepatitis B are estimated to settle in the UK each year.

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