Summary
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 10 mg/day for 48 weeks
as a compassionate therapy. Liver function tests, bile acids, and virological markers
were monitored every 4 weeks. HBV/HDV-specific T cell quantity (up to 48 and 36 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 28 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 10 mg/day, combined with tenofovir disoproxil fumarate,
for the treatment of HDV-related compensated cirrhosis.
Keywords
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Article info
Publication history
Published online: July 11, 2019
Accepted:
July 8,
2019
Received in revised form:
June 15,
2019
Received:
May 1,
2019
Identification
Copyright
© 2019 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
