SMC approves bulevirtide for treatment of chronic HDV infection in Scottish patients

Gilead Sciences has announced that the Scottish Medicines Consortium (SMC) has become the first UK health authority to permit routine NHS use of Hepcludex  (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection.

Bulevirtide has been accepted for restricted use within NHS Scotland for the treatment of chronic HDV infection in adult patients with evidence of significant fibrosis, whose disease has responded inadequately to interferon-based therapy or who are ineligible to receive interferon-based therapy due to intolerance or contra-indication.

John Dillon, Professor of Hepatology and Gastroenterology at the University of Dundee said, “Hepatitis delta virus may be less well known that hepatitis B or C, but it is a very aggressive form of viral hepatitis and chronic infection carries potentially life-threatening consequences. However, to date, there have been severely limited treatment options for those affected. The SMC’s recommendation of bulevirtide is therefore welcome news and marks a pivotal step forward for viral hepatitis care in Scotland.”

HDV is caused by the hepatitis delta virus, which requires the hepatitis beta virus (HBV) in order to replicate. Chronic HDV infection has the highest mortality rate of any of the viral hepatitis’ and is thought to affect millions of people across the globe.

Bulevirtide provides a treatment option for patients that, following appropriate training, can be self-administered at home with a once-daily injection. The conditional marketing authorization was granted based on the results of two-Phase II studies, MYR202 and MYR 203. Additional efficacy and safety data from the ongoing MYR301 Phase III study were presented at the EASL conference in 2022.

Commenting on the SMC’s recommendation, Dr Véronique Walsh, Vice President and General Manager, Gilead Sciences UK & Ireland said, “For years, chronic hepatitis delta virus infection has proven to be a notoriously difficult challenge to treat, with no licensed therapy options in the UK. Recommendation is a vitally important turning point, providing the option of bulevirtide across the NHS in Scotland. Gilead remains committed to helping all those who are impacted by viral hepatitis, and this is another important milestone on this journey.”

The SMC’s recommendation is the first of its kind in the UK. A decision from the National Institute of Health and Care Excellence (NICE), which will provide guidance on its use across the rest of the UK, is scheduled to be made in the near future.