Hundreds of NHS patients in England and Wales offered access to first treatment conditionally licensed for the most aggressive form of viral hepatitis

Hundreds of NHS patients in England and Wales offered access to first treatment conditionally licensed for the most aggressive form of viral hepatitis

- The National Institute for Health and Care Excellence has recommended bulevirtide for the treatment of chronic hepatitis delta virus infection in adult patients.[i] -

- Bulevirtide is a medicine that aims to slow the progression of this disease, which can lead to cirrhosis, liver cancer and death within 5-10 years[ii]^,[iii]  -

15^th MAY 2023, London, UK – Gilead Sciences Ltd today announced that the National Institute for Health and Care Excellence (NICE) has recommended the NHS use of Hepcludex^®  (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection. Bulevirtide is recommended as an option for treating chronic hepatitis D in adults with compensated liver disease only if there is evidence of significant fibrosis (METAVIR stage F2 or above or Ishak stage 3 or above), and their hepatitis has either not responded to peginterferon alfa-2a (PEG-IFN) or they cannot have interferon-based therapy.ⁱ

Bulevirtide is the first medicine to be conditionally licensed for this patient population for use across Great Britain. Despite being the most aggressive form of viral hepatitis, there have historically been severely limited options for people living with this condition. The news today means that hundreds of eligible patients will now have the option of a treatment that aims to slow or halt the potentially life-threatening consequences.^ii,iii

“While many people have heard of hepatitis C and hepatitis B, today chronic hepatitis D infection is arguably the most aggressive and difficult-to-treat form of viral hepatitis. However, despite this reality, there have been no licensed treatment options available for NHS patients in England and Wales,” said Dr. Ahmed Elsharkawy, Consultant Transplant Hepatologist and Honorary Senior Clinical Lecturer at the University of Birmingham. “Today’s news on bulevirtide is very welcome. It means we can finally offer our patients a treatment option that will allow us to target a virus that, in many of our patients, can be life-threatening as it causes serious liver damage and liver cancer.”

HDV infection is relatively rare; it is estimated that around 1,800 people in England have evidence of HDV infection. However, this is likely an underestimate as only a small proportion of patients are thought to be currently diagnosed.[iv] 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.^ii,iii 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.^iii,[vi]

“Despite the exceptional progress that has been made in treating other forms of viral hepatitis over recent years, chronic HDV infection has remained a real challenge,” said Paul Desmond at the Hepatitis B Foundation. “Having NHS access to this medicine will be reassuring for many people who are struggling to live with the reality of this condition. However, we must not forget that a major issue continues to be finding and diagnosing those affected. It is highly likely that hundreds of people may have HDV who do not know it. Ensuring we are screening properly to identify those in need as early as possible will also be vital.”

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 MYR203. Additional efficacy and safety data is being evaluated in the ongoing MYR301 Phase III study. [vii]

“At Gilead, our ambition to end the burden of viral hepatitis and bring innovation to patients is unrelenting. The first conditionally licensed option to treat chronic HDV infection is another step on a remarkable journey,” said Dr Véronique Walsh, Vice President and General Manager, Gilead Sciences UK & Ireland. “Our focus now is to ensure all those who could potentially benefit from bulevirtide are able to do so. We are looking forward to working in partnership with the NHS, hand-in-hand with health professionals and the viral hepatitis community to accelerate uptake so that no one is left without the care and support they need.”

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. Gilead is working with the health authorities in Northern Ireland to make bulevirtide available as quickly as possible. Bulevirtide was accepted by the Scottish Medicines Consortium in March 2023, making it available for restricted use in Scotland.[viii]

[i] NICE FAD – Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta10652/documents. Accessed May 2023.

[ii] 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.

[iii] 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

[iv] Gilead data on file

^[v] Farci P, Niro GA. Current and Future Management of Chronic Hepatitis D. Gastroenterol Hepatol (N Y) 2018;14:342–351.

[vi] 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.

[vii] 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.

[viii] SMC decision on bulevirtide. Available at https://www.scottishmedicines.org.uk/medicines-advice/bulevirtide-hepcludex-full-smc2520/ Accessed May 2023