1 Recommendations

1.1 Bulevirtide is recommended as an option for treating chronic hepatitis D in adults with compensated liver disease only if:

  • there is evidence of significant fibrosis (METAVIR stage F2 or above or Ishak stage 3 or above) and

  • their hepatitis has not responded to peginterferon alfa‑2a (PEG‑IFN) or they cannot have interferon-based therapy.

    Bulevirtide is only recommended if the company provides it according to the commercial arrangement.

1.2 This recommendation is not intended to affect treatment with bulevirtide that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

People with hepatitis D also have hepatitis B. There are no other licensed treatments specifically for hepatitis D. Standard care usually involves treating symptoms and the hepatitis B. People with significant fibrosis (scarring) in their liver can be offered PEG‑IFN, but it is not licensed for this use.

The company positioned bulevirtide for people with chronic hepatitis D who have tried PEG‑IFN and whose condition did not respond to it, or for people who cannot have interferon-based therapy. The company also only positioned it for METAVIR stage F2 or above (which means they have significant fibrosis). Testing for METAVIR stage usually involves a biopsy, which is invasive and may have side effects, and many people decline it. But NICE's guideline on diagnosing and managing chronic hepatitis B recommends transient elastography (FibroScan), which is a non-invasive assessment. It also recommends that hepatitis D with significant fibrosis is defined by a METAVIR stage of F2 or above, or an Ishak stage of 3 or above.

Clinical trial evidence shows that bulevirtide is effective compared with standard care despite some uncertainties around how long it works for. Despite the uncertainties in the clinical trial evidence, the cost-effectiveness estimates are within the range NICE normally considers an acceptable use of NHS resources. So bulevirtide is recommended.