Scottish regulator approves first chronic hepatitis delta virus drug

Scotland

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

The drug has been accepted 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.

HDV infection is rare, but the effects of chronic HDV infection are potentially extremely serious.

Commenting on the news, 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.”

The conditional marketing authorisation was granted based on the results of two Phase II studies, MYR202 and MYR 203.

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. Today’s recommendation is a vitally important turning point, providing the option of bulevirtide across the NHS in Scotland.”

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.

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