NICE issues draft guideline for consultation on the diagnosis and management of hepatitis B
NICE is currently developing a new clinical guideline on the diagnosis and management of chronic hepatitis B in children, young people and adults. Draft recommendations have been published on the NICE website today (17 January) for public consultation.
Chronic hepatitis B is a blood-borne virus that infects the liver. Transmission of the hepatitis B virus (HBV) is by contact with infected blood, primarily as a result of exposure through the skin to contaminated blood and through mother-to-child transmission. A hepatitis B infection is manifested firstly as an acute infection (the first 6 months following initial infection). If the virus is not cleared from the body, either naturally or through the use of drugs to treat the infection, the infection can progress to a chronic state. Although often asymptomatic, particularly in the early stages, chronic hepatitis B infection increases the risk of chronic liver damage, cirrhosis and primary liver cancer.
The incidence of chronic hepatitis B has risen sharply, from 435 new cases in 1990 to 1151 in 2003. However, because in the first years after infection there are often few or no symptoms, and because the diagnosis of hepatitis B is often the result of active screening, the true incidence of the disease is difficult to establish and is likely to have been underestimated. It is thought that approximately 180,000 people in the UK have the condition although this figure may be closer to 360,000 when the estimated 6500-plus people with chronic hepatitis B who migrate to the UK each year are taken into account.
The prevalence of hepatitis B is considerably higher among high-risk groups such as first generation migrants from areas where hepatitis B is endemic; people who have multiple sexual partners; and injecting drug users. A recent report from the Health Protection Agency (HPA)i has found that one in six people who inject drugs were found to have been infected with the hepatitis B virus at some point in their lives.
Substantial progress has been made in the treatment of chronic hepatitis B in the past decade, the primary aims of which are to clear the virus from the blood to prevent progression of liver disease, and to prevent the transmission of the hepatitis B virus. Two classes of drug have been appraised by NICE and are currently used to treat chronic hepatitis B infection: pegylated interferon and nucleoside or nucleotide analoguesii.
The NICE guideline covers: 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; when it is possible to stop treatment; and monitoring for treatment response, severity of fibrosis and development of primary liver cancer.
Professor Mark Baker, Director of the Centre for Clinical Practice at NICE, said: “Chronic hepatitis B can have a significant impact on a person's quality of life, particularly if it progresses to the fibrosis and cirrhosis stage. Fear of transmitting the disease is also a concern, particularly for women of child-bearing age for whom there is a risk of transmitting the disease to their unborn child. NICE recently published public health guidance on increasing the uptake of testing for hepatitis B and C. However, testing is only the first, albeit crucial, stage in reducing both the incidence and the impact of the disease, and a recent audit in London showed that only two-thirds of people with chronic hepatitis B infection diagnosed in primary care were referred for specialist services for assessment. Although substantial progress has been made in the treatment of chronic hepatitis B, there remains strong anecdotal evidence of wide variation in prescribing practice with regard to initial choice of agents and duration of therapy. This guideline is needed to reduce variation in practice and improve the care of people with chronic hepatitis B.”
Stakeholders have until 28 February 2013 to comment on the recommendations in the draft guideline. Organisations can register as stakeholders at any time during the development of the guideline and comments must be submitted via the NICE website. The final recommendations could change depending on feedback received during the development of this guideline.
Notes to Editors
References and explanation of terms
i. Chronic hepatitis B infection causes initial inflammation of the liver that progresses through to gradual scarring (fibrosis) and then hardening of liver tissue (cirrhosis). Cirrhosis commonly occurs in two stages, compensated and decompensated. In the first stage of cirrhosis, the liver can compensate for the damage and still has the ability to function normally. When extensive damage occurs and the liver can no longer function normally, decompensation occurs.
- Tenofovir disoproxil for the treatment of chronic hepatitis B. NICE technology appraisal guidance 173 (2009).
- Telbivudine for the treatment of chronic hepatitis B. NICE technology appraisal guidance 154 (2008).
- Entecavir for the treatment of chronic hepatitis B. NICE technology appraisal guidance 153 (2008).
- 1.1 of Adefovir dipivoxil and peginterferon alfa-2a for the treatment ofchronic hepatitis B. NICE technology appraisal guidance 96 (2006).
About the draft guideline
1. The draft guideline on the diagnosis and management of chronic hepatitis B in children, young people and adults is available on the NICE website.
About hepatitis B
1. Chronic hepatitis B describes a spectrum of disease characterised by the presence of detectable hepatitis B surface antigen (HBsAg) in the blood or serum. Chronic hepatitis B is usually defined as hepatitis B infection that continues for longer than 6 months.
2. In some people, chronic hepatitis B is inactive and does not present significant health problems, but others may progress to liver fibrosis, cirrhosis and hepatocellular carcinoma (HCC).
3. The risk of an acute infection progressing to a chronic infection is closely related to age at acquisition, and varies from 5% in adulthood to more than 90% in perinatal infection.
4. Without antiviral treatment, the 5-year cumulative incidence of cirrhosis ranges from 8 to 20%.
5. People with cirrhosis face a significant risk of decompensated liver disease if they remain untreated. Five-year survival rates among people with untreated decompensated cirrhosis can be as low as 15%.
6. Antiviral therapy suppresses HBV replication and decreases hepatic inflammation and fibrosis, thereby reducing the likelihood of serious clinical disease. Treatment has evolved since the introduction of interferon alpha and now several nucleoside and nucleotide analogues are approved for use in adults with chronic hepatitis B.
7. Although currently available treatment is effective in suppressing HBV replication, it fails to eradicate the virus necessitating long treatment duration and perhaps lifelong treatment.
1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.
2. NICE produces guidance in three areas of health:
- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS
- social care - the Health and Social Care Act (2012) sets out a new responsibility for NICE to develop guidance and quality standards for social care. To reflect this new role, from 1 April 2013 NICE will be called the National Institute for Health and Care Excellence (NICE) and it will become a Non-Departmental Public Body.
3. NICE produces standards for patient care:
- quality standards - these describe high-priority areas for quality improvement in a defined care or service area
- Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients
- CCG Outcomes Indicator Set (formerly known as COF) - NICE develops the potential clinical health improvement indicators to ensure quality of care for patients and communities served by the clinical commissioning groups (CCGs).
4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
This page was last updated: 17 January 2013