First treatment conditionally licensed for chronic hepatitis D

The National Institute for Health and Care Excellence (NICE) has recommended NHS use of Hepcludex^® (bulevirtide). It is the first medicine to be conditionally licensed for chronic hepatitis delta virus (HDV) infection in Great Britain. Gilead Sciences’ antiviral medication is recommended as an option for chronic hepatitis D.

Indicated to treat the most aggressive form of viral hepatitis, bulevirtide is for adults with compensated liver disease only if there is evidence of significant fibrosis and their hepatitis has either not responded to peginterferon alfa-2a (PEG-IFN) or they cannot have interferon-based therapy. Bulevirtide can be self-administered at home with a once-daily injection.  

A regulatory first

Historically, “there have been no licensed treatment options available for NHS patients [with chronic hepatitis D] in England and Wales,” stated Dr Ahmed Elsharkawy, Consultant Transplant Hepatologist and Honorary Senior Clinical Lecturer at the University of Birmingham. Delivered via subcutaneous injection, the peptide-based therapy can target a virus that can be “life-threatening as it causes serious liver damage and liver cancer,” according to Dr Elsharkawy.

NICE’s conditional authorisation of Gilead’s chronic hepatitis D treatment

The conditional marketing authorisation was granted based on the results of two Phase II studies, MYR202 and MYR203. Additional efficacy and safety data is being evaluated in the ongoing MYR301 Phase III study.

The NICE recommendation applies to the NHS in England. However, it is expected that the NHS in Wales will follow this guidance within the coming 60 days.

SMC accepts treatment for chronic hepatitis delta virus

HDV infection is relatively rare. It is estimated that around 1,800 people in England have evidence of HDV infection. Cirrhosis, liver cancer and death within 5-10 years can occur as a result, according to NICE and Gilead.