5.3.3. Viral hepatitis
Restrictions:
Restricted to specialist use for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive patients with compensated liver disease with evidence of significant fibrosis (METAVIR stage ≧ F2) whose disease has responded inadequately to interferon-based therapy or who are ineligible to receive interferon-based therapy due to intolerance or contraindications.
Restrictions:
Restricted to initiation by, or on the advice of, a specialist treating hepatitis B in accordance with local protocol. Use for the treatment of chronic hepatitis B infection in adults with decompensated liver disease is not recommended by SMC and is non-Formulary.
Prescribing Notes:
Entecavir for the treatment of hepatitis B is subject to an agreed Shared Care Protocol whcih allows the ongoing prescribing to be carried out by the patient's GP under guidance and review by the acute specialist.
To access this Shared Care Agreement, and others, click here
Restrictions:
The treatment of chronic hepatitis C virus (HCV) infection in adults is restricted to specialist use only in accordance with local protocol. This is a pangenotype treatment option.
Restrictions:
Restricted to initiation by, or on the advice of, a specialist treating hepatitis B in accordance with local protocol.
Prescribing Notes:
Lamivudine for the treatment of hepatitis B is subject to an agreed Shared Care Protocol whcih allows the ongoing prescribing to be carried out by the patient's GP under guidance and review by the acute specialist.
To access this Shared Care Agreement, and others, click here
Restrictions:
Use in the treatment of chronic hepatitis C (CHC) in adult patients is restricted to specialist use in patients with genotype 1, 3 and 4 chronic hepatitis C in accordance with local protocol and implementation plan.
Prescribing Notes:
Treatment choice will continue to be directed by national guidance.
Restrictions:
Restricted to specialist use only in accordance to national guidelines for the treatment of chronic hepatitis C (CHC).
Restrictions:
Restricted to specialist use only. Restricted to use in adults for the treatment of hepatitis C in combination with ribavirin in accordance with Hepatits MCN protocol.
Restrictions:
Restricted to specialist use only. Use subject to Hepatitis MCN protocol with pegylated interferon alfa in hepatitis C.
Restrictions:
The use in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults is restricted to specialist use in accordance with local protocol (under development).
Prescribing Notes:
The SMC restriction on use is as follows:
Sofosbuvir is accepted for use in patients with genotypes 1 to 6. Use in treatment-naive patients with genotype 2 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa. Use of the 24-week interferon-free regimen of sofosbuvir in combination with ribavirin in patients with genotype 3 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa.
Restrictions:
Use in the treatment of chronic hepatitis C virus (HCV) infection is restricted to specialist use in accordance with local protocol for the following patient groups:
- Genotype 1 chronic HCV infection
- Genotype 2 chronic HCV infection
- Genotype 3 chronic HCV infection
- Genotype 4 chronic HCV infection
- Genotype 5 chronic HCV infection
- Genotype 6 chronic HCV infection
- Patient with decompensated cirrhosis, irrespective of genotype
Restrictions:
Restricted to initiation by, or on the advice of, a specialist treating hepatitis B in accordance with local protocol.
Prescribing Notes:
Tenofovir for the treatment of hepatitis B is subject to an agreed Shared Care Protocol whcih allows the ongoing prescribing to be carried out by the patient's GP under guidance and review by the acute specialist.
To access this Shared Care Agreement, and others, click here
Restrictions:
Use in the treatment of chronic hepatitis C virus (HCV) infection is restricted to use in accordance with local protocol in patients who have failed to acheive a sustained virologic response (SVR) with a direct-acting anti-viral (DAA) or who are DAA-naive, have genotype 3 (GT3) HCV infection, with or without cirrhosis, and are suitable for treatment with an eight-week course.