Hundreds of NHS patients in England and Wales have access to the first conditionally licensed treatment for the most severe form of viral hepatitis
The National Institute for Health and Care Excellence has recommended bulevertide for the treatment of chronic hepatitis delta virus infection in adult patients.[i] –
15lame pants May 2023, London, UK – Gilead Science Ltd today announced that National Institute for Health and Care Excellence (NICE) recommended the NHS to use Hepcludex® (bulevertide) for the treatment of chronic hepatitis delta virus (HDV) infection. Bulevirtide is recommended as an option for the treatment of chronic hepatitis D in adults with compensated liver disease only when there is evidence of significant fibrosis (METAVIR stage F2 or higher or Ishak stage 3 or higher) and Their hepatitis does not respond to peginterferon alfa-2a (PEG-IFN) or they cannot be treated with interferon.I
Bulevertide is the first drug to be conditionally licensed for this group of patients for use across the UK. Despite being the most potent form of viral hepatitis, historically there have been very limited options for people living with the condition. Today’s news means that hundreds of eligible patients will now have the option of treatment to slow or prevent potentially life-threatening consequences.ii, iii
“Although many people have heard of hepatitis C and hepatitis B, today chronic hepatitis D is arguably the most potent and difficult to treat form of viral hepatitis. However, despite this fact, there are no licensed treatment options available to NHS patients in England and Wales.” Dr Ahmed Elsharkawy, Consultant Liver Transplantation and Senior Clinical Lecturer Emeritus at the University of Birmingham. “The news about buevertide today is very welcome. That means we can finally offer our patients a treatment option that allows us to target the virus that, in many of our patients, can be life-threatening. life because it causes severe liver damage and liver cancer.”
HDV infections are relatively rare; It is estimated that around 1,800 people in the UK have evidence of HDV infection. However, this may be underestimated as only a small percentage of patients are thought to be currently diagnosed.[iv] Although not all patients develop chronic HDV infection, the effects of this when it occurs are extremely severe; It is known to often progress to cirrhosis, liver cancer or death within 5-10 years.ii, iii HDV is caused by the hepatitis delta virus, which requires hepatitis beta virus (HBV) to replicate.[v] Chronic HDV infection has the highest mortality rate among viral hepatitis’ and is thought to affect millions of people globally.iii,[vi]
“Despite exceptional advances in the treatment of other forms of viral hepatitis in recent years, chronic HDV infection remains a real challenge,” Paul Desmond at the Hepatitis B Foundation says. “The NHS access to this medicine will give peace of mind to many people who are struggling to live with the realities of this condition. However, we must not forget that a major problem continues to be locating and diagnosing those affected. There is a high chance that hundreds of people may have HDV without knowing it. Making sure we are properly screening to identify people in need as soon as possible will also be important.”
Bulevertide offers a treatment option for patients who, with appropriate training, can self-inject at home with a once-daily injection. A conditional marketing license was granted based on the results of the two Phase II studies, MYR202 and MYR203. Additional efficacy and safety data are being evaluated in the ongoing Phase III MYR301 study. [vii]
“At Gilead, our ambition is to end the burden of viral hepatitis and bring innovation to patients. Conditionally licensed first choice for the treatment of chronic HDV infection is another step in a remarkable journey.” Dr Véronique Walsh, Vice President and General Manager, Gilead Science UK & Ireland said. “Our focus now is on making sure everyone who could potentially benefit from buevertide can do the same. We look forward to working with the NHS, working 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 the UK; however, the NHS in Wales is expected to follow this guidance within the next 60 days. Gilead is working with health authorities in Northern Ireland to deliver bulevertide as quickly as possible. Bulevertide has been approved by Scottish Medicines Association in March 2023, making it available for limited 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. Estimates of global morbidity, disease progression and clinical outcomes of hepatitis virus infection Delta. J infects Dis. 2020 April 27;221(10):1677-1687.
[iii] Da BL, Heller T, Koh C. Hepatitis D infection: from initial detection to current investigational therapies. Representative Gastroenterol (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 (NY) 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 infection. 2018 October;146(13):1612-1618. doi: 10.1017/S0950268818001942. Epub 2018 July 11th. PMID: 29991359; PMCID: PMC9507952.
[vii] Lampertico P, Roulot D, Wedemeyer H. Bulevirtide with or without pegIFNα for patients with compensated chronic hepatitis: From clinical trial to field study. J Hepatol. 2022 November;77(5):1422-1430. doi: 10.1016/j.jhep.2022.06.010. Epub 2022 June 22.
[viii] SMC decision on buevertide. Available at https://www.scottishmedicines.org.uk/medicines-advice/bulevertide-hepcludex-full-smc2520/ Accessed May 2023