Title: Bulevirtide for chronic hepatitis D [ID3732]
Funder: Department of Health and Social Care

Abstract: Hepatitis D, also known as hepatitis Delta, is an infectious disease of the liver caused by the hepatitis D virus (HDV). It only affects people infected with hepatitis B, as it needs the hepatitis B virus (HBV) to be able to survive in the body. Infection may be acquired along with HBV (co-infection) or after HBV infection (superinfection). Similarly to hepatitis B, it usually spreads through blood-to-blood contact or sexual contact. It is also transmitted from mother to child during birth and delivery. Chronic HDV/HBV infection is the most severe form of viral hepatitis, with an increased risk of cirrhosis, liver decompensation, hepatocellular carcinoma and mortality.[1]_x000D_ _x000D_ The majority of people infected with HBV during adulthood make a full recovery and acquire immunity from future infection. Less than 5% of infected adults will develop chronic hepatitis B, defined as viraemia and hepatic inflammation that persists for more than 6 months after acute infection with HBV.[2]_x000D_ _x000D_ Cirrhosis can progress to become ‘decompensated’, where the remaining liver can no longer compensate for the loss of function. There is an increased risk of hepatocellular carcinoma among people with chronic hepatitis B and cirrhosis.[3] The World Health Organisation estimated, that at least 5% of people with chronic HBV infection are co-infected with HDV, resulting in a total of 15 to 20 million persons infected with HDV worldwide.[4] However, the percentage can be higher as not all people with HBV infection get tested for HDV. A retrospective analysis of 962 patients, referred to Kings’ College Hospital in South London between 2000 to 2006 with HBV, showed that 8.5% tested positive for HDV antibodies.[5] The Hospital Episode Statistics for England 2018/19 recorded 21 admissions and 26 finished consultant episodes for chronic viral hepatitis B with D virus infection (ICD-10 code B18.0). While 496 admissions and 427 finished consultant episodes were recorded for chronic viral hepatitis B without D virus infection (ICD-10 code B18.1).[6]_x000D_ _x000D_ The aim of treatment is to prevent transmission, cirrhosis, hepatocellular carcinoma and liver failure. Clinical guidance 165, recommends a 48-week course of peginterferon alfa-2a for people co-infected with chronic hepatitis B and hepatitis D infection who have evidence of significant fibrosis (METAVIR stage greater than or equal to F2 or Ishak stage greater than or equal to 3)._x000D_ _x000D_ References_x000D_ 1. Mentha, N., Clément, S., Negro, F., & Alfaiate, D. (2019). A review on hepatitis D: From virology to new therapies. Journal of advanced research; 17, 3-15._x000D_ 2. World Health Organisation (2019) Guidelines for the prevention, care and treatment of person with chronic hepatitis B infection Accessed February 2020.3. Oakes K (2014) Chronic hepatitis B, part 1: hepatitis B: prevalence and pathophysiology. Nursing Times; 110: 7, 12-16._x000D_ 4. World Health Organisation (2019) Hepatitis D Accessed February 2020._x000D_ 5. Cross, T. J., Rizzi, P., Horner, M., Jolly, A., Hussain, M. J., Smith, H. M., Vergani, D., & Harrison, P. M. (2008). The increasing prevalence of hepatitis delta virus (HDV) infection in South London. Journal of medical virology; 80: 2, 277-282._x000D_ 6. NHS (2019) Hospital Admitted Patient Care Activity 2018-19 Accessed February 2020.

Lay abstract: To appraise the clinical and cost effectiveness of bulevirtide within its marketing authorisation for treating chronic hepatitis D.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: INFECTION