Hepatite B

Principais recomendações do NICE sobre tratamento

Refer to the full NICE guideline and your local drug formulary for further information when prescribing – including dose, contraindications, cautions, safety issues, adverse effects, drug interactions, and monitoring requirements. Please be aware that some of the following indications for medications may not be licensed by the manufacturer (i.e., the use of the medication is 'off-label').

Provide information on lifestyle issues (e.g., alcohol, diet, weight), family planning, and routes of hepatitis B virus transmission, before assessment for antiviral treatment.

Antiviral treatment should be initiated only by an appropriately qualified healthcare professional with expertise in the management of viral hepatitis.

• Before starting treatment, the person’s risk of exposure to HIV should be re-assessed and repeat testing offered if needed.

• Genotype testing should not be offered to determine initial treatment for chronic hepatitis B.

Antiviral treatment for adults

Antiviral treatment for chronic hepatitis B should be:

• Offered to adults who meet any of the following criteria:

  • Aged ≥30 years with HBV DNA >2000 IU/ml and abnormal ALT (≥30 IU/L in males; ≥19 IU/L in females) on 2 consecutive tests conducted 3 months apart

  • Aged <30 years with HBV DNA >2000 IU/ml and abnormal ALT on 2 consecutive tests conducted 3 months apart if there is evidence of necroinflammation or fibrosis on liver biopsy or a transient elastography score >6 kPa

  • HBV DNA >20,000 IU/ml and abnormal ALT on 2 consecutive tests conducted 3 months apart (regardless of age or the extent of liver disease)

  • Cirrhosis and detectable HBV DNA (regardless of HBeAg status, HBV DNA and ALT levels)

• Considered for adults with HBV DNA >2000 IU/ml and evidence of necroinflammation or fibrosis on liver biopsy.

For adults with chronic hepatitis B, who are not co-infected with HIV or hepatitis C or D:

• If they have compensated liver disease: peginterferon alfa-2a should be offered as first-line treatment

  • If second- or third-line treatments are required (e.g., if there is insufficient response to first-line treatment), options include tenofovir disoproxil, entecavir and lamivudine

• If they have decompensated liver disease: first-line treatment options include entecavir and tenofovir disoproxil (peginterferon alfa-2a should not be offered). These people should be managed in conjunction with a liver transplant centre

• Telbivudine is not recommended

• Adefovir dipivoxil should not be offered.

Antiviral treatment for children and young people (without co-infection)

Antiviral treatment should be offered to children and young people with chronic hepatitis B and compensated liver disease (without HIV or hepatitis C or D co-infection) if there is evidence of significant fibrosis (METAVIR stage ≥F2 or Ishak stage ≥3) or abnormal ALT on 2 consecutive tests conducted 3 months apart.

• Peginterferon alfa-2a should be considered as first-line treatment.

• If there is insufficient response to first-line treatment, second-line options include a nucleoside or nucleotide analogue.

Antiviral treatment for women (without co-infection) who are pregnant or breastfeeding

Tenofovir disoproxil should be offered to women (including those aged under 18 years) with chronic hepatitis B (without HIV or hepatitis C or D co-infection) who have HBV DNA >10⁷ IU/ml in the third trimester to reduce the risk of hepatitis B virus transmission to the baby. Treatment should be stopped 4 to 12 weeks after the birth unless the mother meets criteria for long-term treatment.

Active and passive hepatitis B immunisation in infants should be offered and followed up in line with appropriate guidance.

Women should be advised that there is no risk of transmitting hepatitis B virus to the baby through breastfeeding if hepatitis B immunisation guidance has been followed.

• Antiviral treatment may continue while breastfeeding.

Antiviral treatment for adults who are co-infected with hepatitis C or D

Adults co-infected with chronic hepatitis B and hepatitis C should be offered peginterferon alfa and ribavirin.

Adults co-infected with chronic hepatitis B and hepatitis D infection who have evidence of significant fibrosis should be offered peginterferon alfa-2a. Treatment should be stopped after HBsAg seroconversion.

• Bulevirtide is an option for treating chronic hepatitis D in adults with compensated liver disease if there is evidence of significant fibrosis and their hepatitis has not responded to peginterferon alfa-2a or they cannot have interferon-based therapy.

Prophylactic antiviral treatment during immunosuppressive therapy

People who are HBsAg and/or anti-HBc positive should undergo testing (ALT, antibody to hepatitis B surface antigen [anti-HBs], and plasma or serum HBV DNA level) before starting immunosuppressive therapy for autoimmune or atopic diseases, chemotherapy, bone marrow or solid organ transplantation.

• Depending on the results (and the type of immunosuppressive therapy), prophylactic antiviral treatment may be offered before, during and after immunosuppressive therapy. See the NICE guideline for more information on prophylactic treatment.

Monitoring

The choice and timing of review and monitoring tests for people with chronic hepatitis B depends on factors such as: age, whether the person is taking antiviral treatment and what treatment they are taking, HBeAg status, disease phase, previous test results (e.g., evidence of significant fibrosis), and whether liver disease is compensated or decompensated. See the NICE guideline for more information on monitoring.

Hepatocellular carcinoma surveillance

In adults with chronic hepatitis B, 6-monthly surveillance for hepatocellular carcinoma (by hepatic ultrasound and alpha fetoprotein testing) should be:

• Performed in people with significant fibrosis or cirrhosis

• Considered in people without significant fibrosis or cirrhosis if they are >40 years and have a family history of hepatocellular carcinoma and HBV DNA ≥20,000 IU/ml

  • Surveillance should not be offered to people without significant fibrosis or cirrhosis who have HBV DNA <20,000 IU/ml and are <40 years.

© NICE (2013) (2017) All rights reserved. Subject to Notice of rights NICE guidance is prepared for the National Health Service in England https://www.nice.org.uk/terms-and-conditions#notice-of-rights. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.