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Safety and effectiveness of up to 3 years' bulevirtide monotherapy in patients with HDV-related cirrhosis.

Abstract
The entry inhibitor bulevirtide (BLV) received conditional approval from the EMA in July 2020 for the treatment of adult patients with compensated chronic hepatitis delta. However, the effectiveness and safety of BLV administered as monotherapy beyond 48 weeks in difficult-to-treat patients with HDV-related cirrhosis is presently unknown. Herein, we describe the first patients with HDV-related compensated cirrhosis who were treated with BLV (10 mg/day as a starting dose) for up to 3 years on a compassionate use program. Patients were also monitored for HBcrAg and HBV RNA levels, and HDV- and HBV-specific T-cell markers. In the patient who stopped BLV at week 48, after achieving a virological and biochemical response, the initial virological and biochemical rebound was followed by alanine aminotransferase normalization coupled with low HDV RNA and HBsAg levels. In the 2 patients treated continuously for 3 years, virological and biochemical responses were maintained throughout the treatment period even after dose reduction. In a patient with advanced compensated cirrhosis, liver function tests significantly improved, esophageal varices disappeared, and histological/laboratory features of autoimmune hepatitis resolved. Overall, no safety issues were recorded, as bile salt increase was asymptomatic. While serum HBV RNA levels remained undetectable in all patients, HBV core-related antigen levels showed a progressive, yet modest decline during long-term BLV treatment. No HDV-specific interferon-γ-producing T cells were detected, neither after HDV reactivation (after BLV withdrawn in Patient 1) nor during 3 years of BLV treatment. In conclusion, this report shows that continuous administration of BLV monotherapy for 3 years leads to excellent virological and clinical responses in patients with HDV-related cirrhosis who had contraindications to interferon-based therapies.
AuthorsAlessandro Loglio, Peter Ferenci, Sara Colonia Uceda Renteria, Christine Y L Tham, Caroline Scholtes, Heidemarie Holzmann, Florian van Bömmel, Marta Borghi, Riccardo Perbellini, Alessandro Rimondi, Elisa Farina, Elena Trombetta, Maria Manunta, Laura Porretti, Daniele Prati, Ferruccio Ceriotti, Fabien Zoulim, Antonio Bertoletti, Pietro Lampertico
JournalJournal of hepatology (J Hepatol) Vol. 76 Issue 2 Pg. 464-469 (02 2022) ISSN: 1600-0641 [Electronic] Netherlands
PMID34699951 (Publication Type: Case Reports, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2021 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.
Chemical References
  • Antiviral Agents
  • Lipopeptides
  • bulevirtide
Topics
  • Adult
  • Antiviral Agents (pharmacology, therapeutic use)
  • Female
  • Hepatitis D (complications, drug therapy)
  • Humans
  • Lipopeptides (pharmacology, therapeutic use)
  • Liver Cirrhosis (drug therapy, etiology)
  • Liver Function Tests (methods, statistics & numerical data)
  • Male
  • Middle Aged
  • Patient Safety (standards, statistics & numerical data)
  • Treatment Outcome

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