SMC accepts treatment for chronic hepatitis delta virus
Posted: 14 March 2023 | Catherine Eckford (European Pharmaceutical Review) | No comments yet
Bulevirtide has been accepted by the Scottish Medicines Consortium to treat chronic hepatitis delta virus (HDV) infection in adults.
The Scottish Medicines Consortium (SMC) has become the first UK health authority to permit routine NHS use of Hepcludex® (bulevirtide) for chronic hepatitis delta virus (HDV) infection.
All eligible patients will now have the option of the only treatment conditionally approved for HDV infection via NHS Scotland.
Bulevirtide for chronic hepatitis delta virus
Gilead’s bulevirtide aims to slow the progression of chronic hepatitis delta virus infection. It is indicated for adults infected with HDV who have evidence of significant fibrosis. The treatment is permitted under this approval for patients with whom the disease has responded inadequately to interferon-based therapy or who are ineligible to receive interferon-based therapy due to intolerance or contra-indication.
Bulevirtide provides a treatment option for patients that, following appropriate training, can be self-administered at home with a once per day injection. The conditional marketing authorisation was granted based on the results of two Phase II studies, MYR202 and MYR 203. Availability of the first licensed treatment could result in an increase in testing and diagnosis rates of the disease.
Hepatitis delta virus infection is caused by the hepatitis delta virus. It requires the hepatitis beta virus (HBV) in order to replicate. Chronic HDV infection has the highest mortality rate of any of the viral hepatitis’. While not all patients will experience chronic HDV infection, the effects can be serious. For instance, cirrhosis, liver cancer, or death within five to ten years are possible outcomes.
John Dillon, Professor of Hepatology and Gastroenterology at the University of Dundee commented, The SMC’s recommendation of bulevirtide is “welcome news and marks a pivotal step forward for viral hepatitis care in Scotland.”
A regulatory decision from the National Institute of Health and Care Excellence (NICE), which will provide guidance on bulevirtide’s use across the rest of the UK, is scheduled for the near future.
Drug Development, Regulation & Legislation, Research & Development (R&D), Therapeutics, Viruses