Scottish patients with the most aggressive form of viral hepatitis become first in UK to be offered routine NHS access to Hepcludex® (bulevirtide)
pharmafile | March 14, 2023 | News story | Business Services |
Monday 13 March 2023, London, UK – Gilead Sciences Ltd today 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.i
HDV infection is rare; it is estimated that less than 100 people in Scotland have evidence of HDV infection, but this is likely an underestimate, as only a small proportion of patients are currently diagnosed.[ii] The availability of the first licensed treatment may see an increase in testing and diagnosis rates. While not all patients will experience chronic HDV infection, the effects of this when it occurs are potentially extremely serious; it is known to typically progress causing cirrhosis, liver cancer, or death within 5-10 years.[iii],[iv] The news from the SMC today means that all eligible patients will now have the option of the only treatment conditionally approved for HDV infection via NHS Scotland.
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.”
HDV is caused by the hepatitis delta virus, which requires the hepatitis beta virus (HBV) in order to replicate.[v] 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.[vi],[vii]
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. [viii]
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. Today’s 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.
[i] SMC advice #SMC2520 – Available at: [https://]www.scottishmedicines.org.uk/medicines-advice/bulevirtide-hepcludex-full-smc2520/. Last accessed: February 2023.
[ii] Gilead data on file
[iii] Miao Z, Zhang S, Ou X, Li S, Ma Z, Wang W, Peppelenbosch MP, Liu J, Pan Q. Estimating the Global Prevalence, Disease Progression, and Clinical Outcome of Hepatitis Delta Virus Infection. J Infect Dis. 2020 Apr 27;221(10):1677-1687.
[iv] Da BL, Heller T, Koh C. Hepatitis D infection: from initial discovery to current investigational therapies. Gastroenterol Rep(Oxf). 2019;7(4):231-245. doi:10.1093/gastro/goz023
[v] Farci P, Niro GA. Current and Future Management of Chronic Hepatitis D. Gastroenterol Hepatol (N Y) 2018;14:342–351.
[vi] Da BL, Heller T, Koh C. Hepatitis D infection: from initial discovery to current investigational therapies. Gastroenterol Rep (Oxf). 2019;7(4):231–245. doi:10.1093/gastro/goz023
[vii] Romeo R, Petruzziello A, Pecheur EI, Facchetti F, Perbellini R, Galmozzi E, Khan NU, Di Capua L, Sabatino R, Botti G, Loquercio G. Hepatitis delta virus and hepatocellular carcinoma: an update. Epidemiol Infect. 2018 Oct;146(13):1612-1618. doi: 10.1017/S0950268818001942. Epub 2018 Jul 11. PMID: 29991359; PMCID: PMC9507952.
[viii] Lampertico P, Roulot D, Wedemeyer H. Bulevirtide with or without pegIFNα for patients with compensated chronic hepatitis delta: From clinical trials to real-world studies. J Hepatol. 2022 Nov;77(5):1422-1430. doi: 10.1016/j.jhep.2022.06.010. Epub 2022 Jun 22.
