Bulevirtide: the first FDA-approved treatment for chronic hepatitis D
The Food and Drug Administration (FDA) has approved bulevirtide for the treatment of chronic hepatitis D virus (HDV) infection in adults, including those with compensated cirrhosis.
Bulevirtide is a first-in-class viral entry inhibitor that blocks HDV from entering hepatocytes by binding and inactivating the sodium taurocholate cotransporting polypeptide. It is the first drug to receive FDA approval for the treatment of chronic HDV infection.
Clinical trial evidence shows that bulevirtide is effective compared with standard care, although the optimal treatment duration is yet to be determined.[62][63][64][65] The most frequently reported adverse effects were increased total bile acids, injection-site reactions, headache, pruritus, and eosinophilia.[66]
Bulevirtide is contraindicated in patients with decompensated cirrhosis.
Summary
Definition
History and exam
Key diagnostic factors
- jaundice
- ascites
- scleral icterus
- asterixis
Other diagnostic factors
- asymptomatic
- malaise
- fatigue
- hepatomegaly
- fever
- right upper quadrant tenderness
- nausea/vomiting
- arthralgia/arthritis
- palmar erythema
- spider nevi
- splenomegaly
- loss of secondary sexual characteristics
- peripheral edema
Risk factors
- hepatitis B virus (HBV) infection
- increased likelihood of sexual exposure
- injection drug use
- born or living in or travel to geographic regions where hepatitis D virus (HDV) is endemic
- history of incarceration
- family history of hepatitis B virus/hepatitis D virus (HBV/HDV )infection, hepatocellular carcinoma, and/or chronic liver disease
- perinatal exposure in an infant born to an hepatitis D virus (HDV)-infected mother
- men who have sex with men
- household contact with hepatitis D virus (HDV) infection
- healthcare workers
- hemodialysis
Diagnostic tests
1st tests to order
- liver biochemistries
- complete blood count (CBC)
- basic metabolic panel
- coagulation profile
- serum antibody to HDV
- serum HDV RNA
- serum hepatitis B surface antigen
- serum antibody to hepatitis B surface antigen
- serum antibody to hepatitis B core antigen
- serum hepatitis B e antigen
- serum antibody to hepatitis B e antigen
- serum HBV DNA
- abdominal ultrasound
Tests to consider
- testing for coinfections
- liver biopsy
- transient elastography
- serum liver fibrosis biomarkers
Treatment algorithm
acute HDV infection
chronic HDV infection
Contributors
Authors
Jawad Ahmad, MD, FRCP, FAASLD
Professor of Medicine
Division of Liver Diseases
Mount Sinai Hospital
New York, NY
Disclosures
JA declares that he has no competing interests.
Anna Maria Geretti, MD, PhD, FRCPath
Professor and Consultant in Virology & Infectious Diseases
Fondazione PTV
University of Rome Tor Vergata
Rome
Italy
North Middlesex University Hospital
London
UK
King’s College London
London
UK
Disclosures
AMG has received personal payments from Abbott, Gilead, GSK, Roche, and ViiV; research funding (to the institution) from Roche and ViiV.
Peer reviewers
Scott Cotler, MD
Professor of Medicine
Loyola University Chicago
Chicago, IL
Disclosures
SC declares that he has no competing interests.
Peer reviewer acknowledgements
BMJ Best Practice topics are updated on a rolling basis in line with developments in evidence and guidance. The peer reviewers listed here have reviewed the content at least once during the history of the topic.
Disclosures
Peer reviewer affiliations and disclosures pertain to the time of the review.
References
Key articles
European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.Full text Abstract
Terrault NA, Lok ASF, McMahon BJ, et al. Update on prevention, diagnosis, and treatment of chronic hepatitis B: AASLD 2018 hepatitis B guidance. Hepatology. 2018 Apr;67(4):1560-99.Full text Abstract
Urban S, Neumann-Haefelin C, Lampertico P. Hepatitis D virus in 2021: virology, immunology and new treatment approaches for a difficult-to-treat disease. Gut. 2021 Sep;70(9):1782-94.Full text Abstract
Reference articles
A full list of sources referenced in this topic is available to users with access to all of BMJ Best Practice.
Differentials
- Acute viral hepatitis A
- Acute viral hepatitis B
- Acute viral hepatitis C
More DifferentialsGuidelines
- EASL clinical practice guidelines on hepatitis delta virus
- EASL clinical practice guidelines on hepatitis delta virus
More Guidelines
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