Excellent safety and effectiveness of high-dose myrcludex-B monotherapy administered for 48â¯weeks in HDV-related compensated cirrhosis: A case report of 3 patients.
J Hepatol
; 71(4): 834-839, 2019 10.
Article
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| MEDLINE
| ID: mdl-31302176
ABSTRACT
Short-term administration of the entry inhibitor myrcludex-B (MyrB) has been shown to be safe and effective in phase II studies in patients coinfected with hepatitis B virus (HBV) and hepatitis delta virus (HDV). However, its effectiveness and safety are unknown during long-term and high-dose treatment of patients with compensated cirrhosis in real-life settings. Herein, we describe the first 3 European patients with HDV-related compensated cirrhosis who were treated with MyrB 10â¯mg/day for 48â¯weeks as a compassionate therapy. Liver function tests, bile acids, and virological markers were monitored every 4â¯weeks. HBV/HDV-specific T cell quantity (up to 48 and 36â¯weeks) and HBV RNA levels were also assessed in 2 cases. During MyrB treatment, HDV RNA levels progressively declined from 4.4 and 5.6 logs IU/ml to undetectability in 2 cases, and from 6.8 log copies/ml to 500 copies/ml for the other patient. Alanine aminotransferase normalised after 20, 12 and 28â¯weeks, respectively. A significant improvement in features of portal hypertension, liver function tests and alpha-fetoprotein levels were documented in 2 cases. In the male patient with histological and clinical stigmata of autoimmune hepatitis, IgG and immunoglobulins rapidly normalised. No significant changes in HBV surface antigen levels and circulating HBV/HDV-specific T cells were demonstrated; HBV DNA and HBV RNA levels remained undetectable throughout the study period. MyrB was well tolerated; patients remained fully asymptomatic despite a significant increase of bile acids. In conclusion, this report shows excellent safety and effectiveness of a 48-week course of MyrB 10â¯mg/day, combined with tenofovir disoproxil fumarate, for the treatment of HDV-related compensated cirrhosis.
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Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Hepatitis D
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Virus de la Hepatitis Delta
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Virus de la Hepatitis B
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Hepatitis B Crónica
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Lipopéptidos
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Tenofovir
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Cirrosis Hepática
Idioma:
En
Revista:
J Hepatol
Asunto de la revista:
GASTROENTEROLOGIA
Año:
2019
Tipo del documento:
Article
País de afiliación:
Italia