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.
Resumen
Definición
Anamnesis y examen
Principales factores de diagnóstico
- jaundice
- ascites
- scleral icterus
- asterixis
Otros factores de diagnóstico
- 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
Factores de riesgo
- 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
Pruebas diagnósticas
Primeras pruebas diagnósticas para solicitar
- 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
Pruebas diagnósticas que deben considerarse
- testing for coinfections
- liver biopsy
- transient elastography
- serum liver fibrosis biomarkers
Algoritmo de tratamiento
acute HDV infection
chronic HDV infection
Colaboradores
Autores
Jawad Ahmad, MD, FRCP, FAASLD
Professor of Medicine
Division of Liver Diseases
Mount Sinai Hospital
New York, NY
Divulgaciones
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
Divulgaciones
AMG has received personal payments from Abbott, Gilead, GSK, Roche, and ViiV; research funding (to the institution) from Roche and ViiV.
Revisores por pares
Scott Cotler, MD
Professor of Medicine
Loyola University Chicago
Chicago, IL
Divulgaciones
SC declares that he has no competing interests.
Agradecimiento de los revisores por pares
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Divulgaciones
Las afiliaciones y divulgaciones de los revisores por pares se refieren al momento de la revisión.
Referencias
Artículos principales
European Association for the Study of the Liver. EASL clinical practice guidelines on hepatitis delta virus. J Hepatol. 2023 Aug;79(2):433-60.Texto completo Resumen
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.Texto completo Resumen
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.Texto completo Resumen
Artículos de referencia
Una lista completa de las fuentes a las que se hace referencia en este tema está disponible para los usuarios con acceso a todo BMJ Best Practice.

Diferenciales
- Acute viral hepatitis A
- Acute viral hepatitis B
- Acute viral hepatitis C
Más DiferencialesGuías de práctica clínica
- EASL clinical practice guidelines on hepatitis delta virus
- EASL clinical practice guidelines on hepatitis delta virus
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