1 Recommendations

The following guidance is based on the best available evidence. The full guideline gives details of the methods and the evidence used to develop the guidance.

The wording used in the recommendations in this guideline (for example, words such as 'offer' and 'consider') denotes the certainty with which the recommendation is made (the strength of the recommendation). See About this guideline for details.

In this guideline, children and young people are defined as aged up to 18 years. Please follow the recommendations for women who are pregnant for young people with chronic hepatitis B who are pregnant.

1.1 Patient information

1.1.1 Provide information on the following topics to people with chronic hepatitis B and to family members or carers (if appropriate) before assessment for antiviral treatment:

  • the natural history of chronic hepatitis B, including stages of disease and long-term prognosis

  • lifestyle issues such as alcohol, diet and weight

  • family planning

  • monitoring

  • routes of hepatitis B virus (HBV) transmission

  • the benefits of antiviral treatment, including reduced risk of serious liver disease and death and reduced risk of transmission of HBV to others

  • treatment options and contraindications based on the patient's circumstances, including peginterferon alfa-2a and nucleoside or nucleotide analogues

  • short- and long-term treatment goals

  • causes of treatment failure, including non-adherence to prescribed medicines, and options for re-treatment

  • risks of treatment, including adverse effects and drug resistance.

1.1.2 Offer a copy of the personalised care plan to people with chronic hepatitis B and to family members or carers (if appropriate) outlining proposed treatment and long-term management, for example, a copy of the hospital consultation summary.

1.1.3 Provide information on self-injection techniques to people beginning peginterferon alfa-2a or to family members or carers.

1.1.4 NICE has produced public health guidance on ways to promote and offer testing to people at increased risk of infection with hepatitis B. All healthcare professionals should follow the recommendations in Hepatitis B and C: ways to promote and offer testing to people at increased risk of infection (NICE public health guidance 43).

1.1.5 NICE has produced guidance on the components of good patient experience in adult NHS services. All healthcare professionals should follow the recommendations in Patient experience in adult NHS services (NICE clinical guidance 138).

1.2 Assessment and referral in primary care

Adults who are HBsAg positive

1.2.1 Arrange the following tests in primary care for adults who are hepatitis B surface antigen (HBsAg) positive:

  • hepatitis B e antigen (HBeAg)/antibody (anti-HBe) status

  • HBV DNA level

  • IgM antibody to hepatitis B core antigen (anti-HBc lgM)

  • hepatitis C virus antibody (anti-HCV)

  • hepatitis delta virus antibody (anti-HDV)

  • HIV antibody (anti-HIV)

  • lgG antibody to hepatitis A virus (anti-HAV)

  • additional laboratory tests including alanine aminotransferase (ALT) or aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), serum albumin, total bilirubin, total globulins, full blood count and prothrombin time

  • tests for hepatocellular carcinoma (HCC), including hepatic ultrasound and alpha-fetoprotein testing.

1.2.2 Refer all adults who are HBsAg positive to a hepatologist or to a gastroenterologist or infectious disease specialist with an interest in hepatology.

1.2.3 Include the results of the initial tests with the referral (see recommendation 1.2.1).

Pregnant women who test HBsAg positive at antenatal screening

1.2.4 Refer pregnant women who are HBsAg positive to a hepatologist, or to a gastroenterologist or infectious disease specialist with an interest in hepatology, for assessment within 6 weeks of receiving the screening test result and to allow treatment in the third trimester (see recommendation 1.5.39).

Adults with decompensated liver disease

1.2.5 Refer adults who develop decompensated liver disease immediately to a hepatologist or to a gastroenterologist with an interest in hepatology. Symptoms of decompensated liver disease include (but are not limited to) ascites, encephalopathy and gastrointestinal haemorrhage.

Children and young people who are HBsAg positive

1.2.6 Arrange the following tests for children and young people who are HBsAg positive:

  • HBeAg/anti-HBe status

  • HBV DNA level

  • anti-HBc lgM

  • anti-HCV

  • anti-HDV

  • anti-HIV

  • anti-HAV

  • additional laboratory tests, including ALT or AST, GGT, serum albumin, total bilirubin, total globulins, full blood count and prothrombin time

  • tests for HCC, including hepatic ultrasound and alpha-fetoprotein testing.

1.2.7 Refer all children and young people who are HBsAg positive to a paediatric hepatologist or to a gastroenterologist or infectious disease specialist with an interest in hepatology.

1.2.8 Include the results of the initial tests with the referral (see recommendation 1.2.6).

1.3 Assessment of liver disease in secondary specialist care

Adults with chronic hepatitis B

Please refer to recommendations 1.5.3 to 1.5.7 for detailed guidance on offering antiviral treatment.

1.3.1 Ensure all healthcare professionals who refer adults for non-invasive tests for liver disease are trained to interpret the results and aware of co-factors that influence liver elasticity (for example, fatty liver caused by obesity or alcohol misuse).

1.3.2 Discuss the accuracy, limitations and risks of the different tests for liver disease with the patient.

1.3.3 Offer transient elastography as the initial test for liver disease in adults newly referred for assessment.

1.3.4 Offer antiviral treatment without a liver biopsy to adults with a transient elastography score greater than or equal to 11 kPa[4], in line with recommendation 1.5.6.

1.3.5 Consider liver biopsy to confirm the level of fibrosis in adults with a transient elastography score between 6 and 10 kPa[5]. Offer antiviral treatment in line with recommendations 1.5.3 to 1.5.7.

1.3.6 Offer liver biopsy to adults with a transient elastography score less than 6 kPa if they are younger than 30 years and have HBV DNA greater than 2000 IU/ml and abnormal ALT (greater than or equal to 30 IU/L for males and greater than or equal to 19 IU/L for females) on 2 consecutive tests conducted 3 months apart[6]. Offer antiviral treatment in line with recommendations 1.5.3 to 1.5.7.

1.3.7 Do not offer liver biopsy to adults with a transient elastography score less than 6 kPa who have normal ALT (less than 30 IU/L in males and less than 19 IU/L in females) and HBV DNA less than 2000 IU/ml as they are unlikely to have advanced liver disease or need antiviral treatment (see recommendations 1.5.3 to 1.5.7)[6].

1.3.8 Offer an annual reassessment of liver disease using transient elastography to adults who are not taking antiviral treatment.

Children and young people with chronic hepatitis B

1.3.9 Discuss the accuracy, limitations and risks of liver biopsy in determining the need for antiviral treatment with the child or young person and with parents or carers (if appropriate).

1.3.10 Consider liver biopsy to assess liver disease and the need for antiviral treatment in children and young people with HBV DNA greater than 2000 IU/ml and abnormal ALT (greater than or equal to 30 IU/L for males and greater than or equal to 19 IU/L for females) on 2 consecutive tests conducted 3 months apart. Offer biopsy under a general anaesthetic to children who are too young to tolerate the procedure under a local anaesthetic.

1.4 Genotype testing

1.4.1 Do not offer genotype testing to determine initial treatment in people with chronic hepatitis B.

1.5 Antiviral treatment

Adults with chronic hepatitis B

Recommendations 1.5.8 to 1.5.12 are reproduced from existing NICE technology appraisals on options for the treatment of chronic hepatitis B, and 1.5.13 to 1.5.15 update guidance in NICE technology appraisal 96[7]. The GDG has reviewed the evidence and has made recommendations on treatment sequences and combination drug regimens (see recommendations 1.5.16 to 1.5.28).

Recommendations 1.5.8 to 1.5.43 do not apply to people with chronic hepatitis B who also have hepatitis C, hepatitis D or HIV.

1.5.1 Discuss treatment options, adverse effects and long-term prognosis with the patient before starting treatment.

1.5.2 Re-assess the person's risk of exposure to HIV before starting treatment and offer repeat testing if needed.

1.5.3 Offer antiviral treatment to adults aged 30 years and older who have HBV DNA greater than 2000 IU/ml and abnormal ALT (greater than or equal to 30 IU/L in males and greater than or equal to 19 IU/L in females) on 2 consecutive tests conducted 3 months apart.

1.5.4 Offer antiviral treatment to adults younger than 30 years who have HBV DNA greater than 2000 IU/ml and abnormal ALT (greater than or equal to 30 IU/L in males and greater than or equal to 19 IU/L in females) on 2 consecutive tests conducted 3 months apart if there is evidence of necroinflammation or fibrosis on liver biopsy or a transient elastography score greater than 6 kPa.

1.5.5 Offer antiviral treatment to adults who have HBV DNA greater than 20,000 IU/ml and abnormal ALT (greater than or equal to 30 IU/L in males and greater than or equal to 19 IU/L in females) on 2 consecutive tests conducted 3 months apart regardless of age or the extent of liver disease.

1.5.6 Offer antiviral treatment to adults with cirrhosis and detectable HBV DNA, regardless of HBeAg status, HBV DNA and ALT levels.

1.5.7 Consider antiviral treatment in adults with HBV DNA greater than 2000 IU/ml and evidence of necroinflammation or fibrosis on liver biopsy.

1.5.8 Peginterferon alfa-2a is recommended as an option for the initial treatment of adults with chronic hepatitis B (HBeAg-positive or HBeAg-negative), within its licensed indications. [This recommendation is from Adefovir dipivoxil and peginterferon alfa-2a for the treatment of chronic hepatitis B (NICE technology appraisal guidance 96).]

1.5.9 Entecavir, within its marketing authorisation, 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 recommendation is from Entecavir for the treatment of chronic hepatitis B (NICE technology appraisal guidance 153).]

1.5.10 Tenofovir disoproxil, within its marketing authorisation, 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 recommendation is from Tenofovir disoproxil fumarate for the treatment of hepatitis B (NICE technology appraisal guidance 173).]

1.5.11 Telbivudine is not recommended for the treatment of chronic hepatitis B. [This recommendation is from Telbivudine for the treatment of chronic hepatitis B (NICE technology appraisal guidance 154).]

1.5.12 People currently receiving telbivudine should have the option to continue therapy until they and their clinicians consider it appropriate to stop. [This recommendation is from Telbivudine for the treatment of chronic hepatitis B (NICE technology appraisal guidance 154).]

1.5.13 Do not offer adefovir dipivoxil for treatment of chronic hepatitis B.

1.5.14 People currently receiving adefovir dipivoxil should be offered the option to switch to a different treatment. Offer tenofovir disoproxil or entecavir, depending on previous antiviral exposure:

  • offer tenofovir disoproxil to people with a history of lamivudine resistance.

1.5.15 Antiviral treatment should be initiated only by an appropriately qualified healthcare professional with expertise in the management of viral hepatitis. Continuation of therapy under shared-care arrangements with a GP is appropriate.

Treatment sequence in adults with HBeAg-positive chronic hepatitis B and compensated liver disease

1.5.16 Offer a 48-week course of peginterferon alfa-2a as first-line treatment in adults with HBeAg-positive chronic hepatitis B and compensated liver disease[8].

1.5.17 Consider stopping peginterferon alfa-2a 24 weeks after starting treatment if HBV DNA level has decreased by less than 2 log10 IU/ml and/or if HBsAg is greater than 20,000 IU/ml, and offer second-line treatment in line with recommendations 1.5.18 and 1.5.19.

1.5.18 Offer tenofovir disoproxil as second-line treatment to people who do not undergo HBeAg seroconversion or who relapse (revert to being HBeAg positive following seroconversion) after first-line treatment with peginterferon alfa-2a.

1.5.19 Offer entecavir as an alternative second-line treatment to people who cannot tolerate tenofovir disoproxil or if it is contraindicated.

1.5.20 Review adherence in people taking tenofovir disoproxil who have detectable HBV DNA at 48 weeks of treatment and, if appropriate, provide support in line with Medicines adherence (NICE clinical guidance 76).

  • If HBV DNA remains detectable at 96 weeks, and there is no history of lamivudine resistance, consider adding lamivudine to tenofovir disoproxil.

  • In people with a history of lamivudine resistance, consider adding entecavir to tenofovir disoproxil.

1.5.21 Consider stopping nucleoside or nucleotide analogue treatment 12 months after HBeAg seroconversion in people without cirrhosis.

1.5.22 Do not stop nucleoside or nucleotide analogue treatment 12 months after HBeAg seroconversion in people with cirrhosis.

Treatment sequence in adults with HBeAg-negative chronic hepatitis B and compensated liver disease

1.5.23 Offer a 48-week course of peginterferon alfa-2a as first-line treatment in adults with HBeAg-negative chronic hepatitis B and compensated liver disease[8].

1.5.24 Consider stopping peginterferon alfa-2a 24 weeks after starting treatment if HBV DNA level has decreased by less than 2 log10 IU/ml and HBsAg has not decreased, and consider second-line treatment in line with recommendation 1.5.25.

1.5.25 Offer entecavir or tenofovir disoproxil as second-line treatment to people with detectable HBV DNA after first-line treatment with peginterferon alfa-2a.

1.5.26 Consider switching from tenofovir disoproxil to entecavir, or from entecavir to tenofovir disoproxil, as third-line treatment in people who have detectable HBV DNA at 48 weeks of treatment.

1.5.27 Consider stopping nucleoside or nucleotide analogue treatment 12 months after achieving undetectable HBV DNA and HBsAg seroconversion in people without cirrhosis.

1.5.28 Do not stop nucleoside or nucleotide analogue treatment after achieving undetectable HBV DNA and HBsAg seroconversion in patients with cirrhosis.

Children and young people with chronic hepatitis B and compensated liver disease

1.5.29 Discuss treatment options, adverse effects and long-term prognosis with the child or young person and with parents or carers (if appropriate) before starting treatment.

1.5.30 Re-assess the child or young person's risk of exposure to HIV before starting treatment and offer repeat testing if necessary.

1.5.31 Offer antiviral treatment if there is evidence of significant fibrosis (METAVIR stage greater than or equal to F2 or Ishak stage greater than or equal to 3) or abnormal ALT (greater than or equal to 30 IU/L for males and greater than or equal to 19 IU/L for females) on 2 consecutive tests conducted 3 months apart.

1.5.32 Consider a 48-week course of peginterferon alfa-2a as first-line treatment in children and young people with chronic hepatitis B and compensated liver disease[8],[9].

1.5.33 Consider stopping peginterferon alfa-2a 24 weeks after starting treatment if HBV DNA level has decreased by less than 2 log10 IU/ml and/or if HBsAg is greater than 20,000 IU/ml.

1.5.34 Consider a nucleoside or nucleotide analogue as second-line treatment in children and young people with detectable HBV DNA after first-line treatment with peginterferon alfa-2a[10].

Adults with decompensated liver disease

1.5.35 Manage decompensated liver disease in adults in conjunction with a liver transplant centre.

1.5.36 Do not offer peginterferon alfa-2a to people with chronic hepatitis B and decompensated liver disease.

1.5.37 Offer entecavir as first-line treatment in people with decompensated liver disease if there is no history of lamivudine resistance.

  • Offer tenofovir disoproxil to people with a history of lamivudine resistance.

  • Reduce the dose of tenofovir disoproxil in people with renal impairment, in line with guidance in the summary of product characteristics.

Women who are pregnant or breastfeeding

1.5.38 Discuss with pregnant women the benefits and risks of antiviral treatment for them and their baby.

1.5.39 Offer tenofovir disoproxil to women with HBV DNA greater than 107 IU/ml in the third trimester to reduce the risk of transmission of HBV to the baby[11].

1.5.40 Monitor quantitative HBV DNA 2 months after starting tenofovir disoproxil and ALT monthly after the birth to detect postnatal HBV flares in the woman.

1.5.41 Stop tenofovir disoproxil 4 to 12 weeks after the birth unless the mother meets criteria for long-term treatment (see recommendations 1.5.4 to 1.5.8).

1.5.42 Offer active and passive hepatitis B immunisation in infants and follow up in line with the guidance below:

1.5.43 Advise women that there is no risk of transmitting HBV to their babies through breastfeeding if guidance on hepatitis B immunisation has been followed, and that they may continue antiviral treatment while they are breastfeeding.

Adults who are co-infected with hepatitis C

1.5.44 Offer peginterferon alfa and ribavirin in adults co-infected with chronic hepatitis B and C[8].

Adults who are co-infected with hepatitis D

1.5.45 Offer a 48-week course of peginterferon alfa-2a in people co-infected with chronic hepatitis B and hepatitis delta infection who have evidence of significant fibrosis (METAVIR stage greater than or equal to F2 or Ishak stage greater than or equal to 3)[8].

1.5.46 Consider stopping peginterferon alfa-2a if there is no decrease in HDV RNA after 6 months to 1 year of treatment. Otherwise, continue treatment and re-evaluate treatment response annually.

1.5.47 Stop treatment after HBsAg seroconversion.

Prophylactic treatment during immunosuppressive therapy

1.5.48 Perform the following tests in people who are HBsAg and/or anti-HBc positive before starting immunosuppressive therapy for autoimmune or atopic diseases, chemotherapy, bone marrow or solid organ transplantation:

  • antibody to hepatitis B surface antigen (anti-HBs)

  • plasma or serum HBV DNA level

  • ALT.

1.5.49 In people who are HBsAg positive and have HBV DNA greater than 2000 IU/ml, offer prophylaxis with entecavir or tenofovir disoproxil[12].

  • Start prophylaxis before beginning immunosuppressive therapy and continue for a minimum of 6 months after HBeAg seroconversion and HBV DNA is undetectable.

1.5.50 In people who are HBsAg positive and have HBV DNA less than 2000 IU/ml, offer prophylaxis.

  • Consider lamivudine[12] if immunosuppressive therapy is expected to last less than 6 months.

    • Monitor HBV DNA monthly in people treated with lamivudine and change to tenofovir disoproxil if HBV DNA remains detectable after 3 months.

  • Consider entecavir or tenofovir disoproxil[12] if immunosuppressive therapy is expected to last longer than 6 months.

  • Start prophylaxis before beginning immunosuppressive therapy and continue for a minimum of 6 months after stopping immunosuppressive therapy.

1.5.51 In people who are HBsAg negative and anti-HBc positive (regardless of anti-HBs status) and are starting rituximab or other B cell-depleting therapies:

  • offer prophylaxis with lamivudine[12]

  • start prophylaxis before beginning immunosuppressive therapy and continue for a minimum of 6 months after stopping immunosuppressive therapy.

1.5.52 In people who are HBsAg negative, anti-HBc positive and anti-HBs negative and are not taking rituximab or other B cell-depleting therapies:

  • monitor HBV DNA monthly and offer prophylaxis to people whose HBV DNA becomes detectable

    • consider lamivudine[12] in people with HBV DNA less than 2000 IU/ml and for whom immunosuppressive therapy is expected to last less than 6 months; change to tenofovir disoproxil if HBV DNA remains detectable after 6 months

    • consider entecavir or tenofovir disoproxil[12] in people with HBV DNA greater than 2000 IU/ml and for whom immunosuppressive therapy is expected to last longer than 6 months

    • continue antiviral therapy for a minimum of 6 months after stopping immunosuppressive therapy.

1.5.53 Do not offer prophylaxis to people who are HBsAg negative and anti-HBc and anti-HBs positive who are not taking rituximab or other B cell-depleting therapies.

1.6 Monitoring

Monitoring in people who do not meet criteria for antiviral treatment

Further information on the progression of chronic hepatitis B can be found in the Introduction (see Figure 1).

Adults with HBeAg-positive disease in the immune-tolerant and immune clearance phases

1.6.1 Monitor ALT levels every 24 weeks in adults with HBeAg-positive disease who are in the immune-tolerant phase (defined by active viral replication and normal ALT levels [less than 30 IU/L in males and less than 19 IU/L in females]).

1.6.2 Monitor ALT every 12 weeks on at least 3 consecutive occasions if there is an increase in ALT levels.

Adults with inactive chronic hepatitis B (immune-control phase)

1.6.3 Monitor ALT and HBV DNA levels every 48 weeks in adults with inactive chronic hepatitis B infection (defined as HBeAg negative on 2 consecutive tests with normal ALT [less than 30 IU/L in males and less than 19 IU/L in females] and HBV DNA less than 2000 IU/ml).

  • Consider monitoring more frequently (for example, every 12–24 weeks) in people with cirrhosis who have undetectable HBV DNA.

Children and young people

1.6.4 Monitor ALT levels every 24 weeks in children and young people with HBeAg-positive disease who have normal ALT levels (less than 30 IU/L for males and less than 19 IU/L for females) and no evidence of significant fibrosis (METAVIR stage less than F2 or Ishak stage less than 3).

1.6.5 Review annually children and young people with HBeAg-negative disease who have normal ALT (less than 30 IU/L for males and less than 19 IU/L for females), no evidence of significant fibrosis (METAVIR stage less than F2 or Ishak stage less than 3) and HBV DNA less than 2000 IU/ml.

1.6.6 Review every 12 weeks children and young people with HBeAg-negative disease who have abnormal ALT (greater than or equal to 30 IU/L for males and greater than or equal to 19 IU/L for females) and HBV DNA greater than 2000 IU/ml.

Children, young people and adults with HBeAg or HBsAg seroconversion after antiviral treatment

1.6.7 In people with HBeAg seroconversion after antiviral treatment, monitor HBeAg, anti-HBe, HBV DNA level and liver function at 4, 12 and 24 weeks after HBeAg seroconversion and then every 6 months.

1.6.8 Monitor HBsAg and anti-HBs annually in people with HBsAg seroconversion after antiviral treatment and discharge people who are anti-HBs positive on 2 consecutive tests.

Monitoring in people taking antiviral treatment

Children, young people and adults taking peginterferon alfa-2a

1.6.9 Review injection technique and adverse effects weekly during the first month of treatment in people taking peginterferon alfa-2a[10].

1.6.10 Monitor full blood count, liver function (including bilirubin, albumin and ALT), renal function (including urea and electrolyte levels) and thyroid function (and in children, weight and height) before starting peginterferon alfa-2a and 2, 4, 12, 24, 36 and 48 weeks after starting treatment to detect adverse effects[10].

1.6.11 Monitor HBV DNA and quantitative HBsAg levels and HBeAg status before starting peginterferon alfa-2a at 12, 24 and 48 weeks after starting treatment to determine treatment response[10].

Children, young people and adults with compensated liver disease taking entecavir or lamivudine

1.6.12 Monitor full blood count, liver function (including bilirubin, albumin and ALT) and renal function (including urea and electrolyte levels) in people with compensated liver disease before starting entecavir or lamivudine, 4 weeks after starting treatment and then every 3 months to detect adverse effects[10].

1.6.13 Monitor HBV DNA and quantitative HBsAg levels and HBeAg status before starting entecavir or lamivudine, 12, 24 and 48 weeks after starting treatment and then every 6 months to determine treatment response and medicines adherence[10].

1.6.14 Monitor HBV DNA levels every 12 weeks in people with HBeAg-negative disease who have been taking lamivudine for 5 years or longer[10].

Children, young people and adults with compensated liver disease taking tenofovir disoproxil

1.6.15 Monitor full blood count, liver function (including bilirubin, albumin and ALT), renal function (including urea and electrolyte levels and urine protein/creatinine ratio), and phosphate levels in people with compensated liver disease before starting tenofovir disoproxil, 4 weeks after starting treatment and then every 3 months to detect adverse effects[10].

1.6.16 Monitor HBV DNA and quantitative HBsAg levels and HBeAg status before starting tenofovir disoproxil, 12, 24 and 48 weeks after starting treatment and then every 6 months to determine treatment response and medicines adherence[10].

Children, young people and adults with decompensated liver disease who are taking entecavir or lamivudine

1.6.17 Monitor full blood count, liver function (including bilirubin, albumin and ALT), renal function (including urea and electrolyte levels and urine protein/creatinine ratio), blood clotting, HBV DNA level and HBeAg status in people with decompensated liver disease before starting entecavir or lamivudine and weekly after starting treatment to assess treatment response and adverse effects. When the person is no longer decompensated, follow the recommendations in 'Children, young people and adults with compensated liver disease taking entecavir or lamivudine'[10].

Children, young people and adults with decompensated liver disease who are taking tenofovir disoproxil

1.6.18 Monitor full blood count, liver function (including bilirubin, albumin and ALT), renal function (including urea and electrolyte levels and urine protein/creatinine ratio) and phosphate, blood clotting, HBV DNA level and HBeAg status in people with decompensated liver disease before starting tenofovir disoproxil and weekly after starting treatment to assess treatment response and adverse effects. When the person is no longer decompensated, follow the recommendations in 'Children, young people and adults with compensated liver disease taking tenofovir disoproxil'[10].

1.7 Surveillance testing for hepatocellular carcinoma in adults with chronic hepatitis B

1.7.1 Perform 6-monthly surveillance for HCC by hepatic ultrasound and alpha-fetoprotein testing in people with significant fibrosis (METAVIR stage greater than or equal to F2 or Ishak stage greater than or equal to 3) or cirrhosis.

1.7.2 In people without significant fibrosis or cirrhosis (METAVIR stage less than F2 or Ishak stage less than 3), consider 6-monthly surveillance for HCC if the person is older than 40 years and has a family history of HCC and HBV DNA greater than or equal to 20,000 IU/ml.

1.7.3 Do not offer surveillance for HCC in people without significant fibrosis or cirrhosis (METAVIR stage less than F2 or Ishak stage less than 3) who have HBV DNA less than 20,000 IU/ml and are younger than 40 years.

More information

You can also see this guideline in the NICE pathway on hepatitis B (chronic).

To find out what NICE has said on topics related to this guideline, see our web page on hepatitis.

See also the guideline committee's discussion and the evidence reviews (in the full guideline), and information about how the guideline was developed, including details of the committee.



[4] Adults with a transient elastography score greater than or equal to 11 kPa are very likely to have cirrhosis and confirmation by liver biopsy is not needed.

[5] The degree of fibrosis cannot be accurately predicted in adults with a transient elastography score between 6 to 10 kPa. Some people may choose to have a liver biopsy in these circumstances to confirm the extent of liver disease.

[6] Adults with a transient elastography score less than 6 kPa are unlikely to have significant fibrosis.

[7] Adefovir dipivoxil and peginterferon alfa-2a for the treatment of chronic hepatitis B (NICE technology appraisal guidance 96), Entecavir for the treatment of chronic hepatitis B (NICE technology appraisal guidance 153), Telbivudine for the treatment of chronic hepatitis B (NICE technology appraisal guidance 154) and Tenofovir disoproxil fumarate for the treatment of hepatitis B (NICE technology appraisal guidance 173).

[8] Avoid use of peginterferon alfa-2a in pregnancy unless the potential benefit outweighs risk. Women of childbearing potential must use effective contraception throughout therapy.

[9] At the time of publication (June 2013), peginterferon alfa-2a did not have a UK marketing authorisation for use in children for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Good practice in prescribing medicines – guidance for doctors for further information.

[10] At the time of last review (October 2017), peginterferon alfa-2a did not have a UK marketing authorisation for use in children for this indication, tenofovir disoproxil did not have a UK marketing authorisation for use in children younger than 12 years for this indication and entecavir did not have a UK marketing authorisation for use in children younger than 2 years for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Good practice in prescribing medicines – guidance for doctors for further information.

[11] At the time of publication (June 2013), tenofovir disoproxil did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Good practice in prescribing medicines – guidance for doctors for further information.

[12] At the time of publication (June 2013), entecavir, lamivudine and tenofovir disoproxil did not have a UK marketing authorisation for this indication. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. Informed consent should be obtained and documented. See the General Medical Council's Good practice in prescribing medicines – guidance for doctors for further information.

  • National Institute for Health and Care Excellence (NICE)