Safety and efficacy of off-label bulevirtide monotherapy in patients with HDV with decompensated Child-B cirrhosis-A real-world case series
- PMID: 38478755
- PMCID: PMC11332372
- DOI: 10.1097/HEP.0000000000000847
Safety and efficacy of off-label bulevirtide monotherapy in patients with HDV with decompensated Child-B cirrhosis-A real-world case series
Abstract
Background and aims: Chronic hepatitis D is the most debilitating form of viral hepatitis frequently progressing to cirrhosis and subsequent decompensation. However, the HDV entry inhibitor bulevirtide is only approved for antiviral treatment of patients with compensated disease. We aimed for the analysis of real-world data on the off-label use of bulevirtide in the setting of decompensated liver cirrhosis.
Approach and results: We conducted a retrospective study in patients with HDV with decompensated liver disease at German, Austrian, and Italian centers. We included 19 patients (47% male, mean age: 51 years) with liver cirrhosis Child-Pugh B. The median MELD score was 12 (range 9-17) at treatment initiation. The median observation period was 41 weeks. Virologic response was achieved in 74% and normal alanine aminotransferase was observed in 74%. The combined response was achieved by 42%. The most relevant adverse events included self-limited alanine aminotransferase flares, an asymptomatic increase in bile acids, and the need for liver transplantation. Despite bile acid increases, adverse events were considered unrelated. Clinical and laboratory improvement from Child-Pugh B to A occurred in 47% (n = 9/19). Improvements in the amount of ascites were observed in 58% of the patients initially presenting with ascites (n = 7/12).
Conclusions: This report on off-label bulevirtide treatment in patients with decompensated HDV cirrhosis shows similar virologic and biochemical response rates as observed in compensated liver disease. Significant improvements were observed in surrogates of hepatic function and portal hypertension. However, this improvement was not seen in all patients. Controlled trials are needed to confirm the safety and efficacy of bulevirtide in decompensated HDV cirrhosis.
Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.
Conflict of interest statement
Christopher Dietz-Fricke received grants from Gilead. Elisabetta Degasperi consults, is on the speakers’ bureau, and received grants from AbbVie, Gilead, and Intercept. She consults for Roche. She received grants from Advanz. Mathias Jachs consults, is on the speakers’ bureau, and received grants from Gilead. Benjamin Maasoumy consults, is on the speakers’ bureau, and received grants from AbbVie and Roche. He consults and is on the speakers’ bureau for Norgine. He is on the speakers’ bureau and received grants from Fujirebio and Gilead. He consults for Luvos. He is on the speakers’ bureau for W. L. Gore, Medical Tribune and Forum, and MSD. He received grants from Altona and ewimed GmbH. He owns stock in Biontech. Florian P. Reiter advises, is on the speakers’ bureau, and received grants from Gilead. He is on the speakers’ bureau and received grants from AbbVie, AstraZeneca, Falk, Ipsen, and Novartis. Andreas Geier consults, is on the speakers’ bureau, and received grants from AbbVie, Falk, Intercept, and Novartis. He consults and is on the speakers’ bureau for Advanz, Alexion, Bristol Myer Squibb, CSL Behring, Gilead, Merz, MSD, and Roche. He consults for Bayer, Eisai, Heel, Ipsen, Novo Nordisk, Pfizer, Sanofi, and Sequana. He is on the speakers’ bureau for Burgenstein. Kathrin Sprinzl advises, is on the speakers’ bureau, and received grants from Gilead. She is on the speakers’ bureau for AbbVie and Bristol Myers Squibb. Stefan Zeuzem consults and is on the speakers’ bureau for Gilead. He is on the speakers’ bureau and received grants from AbbVie, Gilead, and MSD. He consults for BioMarin, GlaxoSmithKline, Madrigal, and Novo Nordisk. He consults for Ipsen and SoBi. He advises Boehringer Ingelheim. Bernhard Schlevogt advises and received grants from Gilead. He advises Univar. He is on the speakers’ bureau for Alnylam. He received grants from AbbVie. Toni Herta consults and received grants from Albireo. He consults for Advanz. Heiner Wedemeyer consults, advises, and is on the speakers’ bureau for Dr. Falk, MSD, and Gilead. He consults, advises, and received grants from Abbott. He consults and advises Albireo, AstraZeneca, Atea, Bristol Myers-Squibb, Eli Lilly, F. Hoffmann-La Roche, GlaxoSmithKline, Janssen, Mirum, Orphalan, Pfizer, Roche, Sobi, Takeda, and Vir. He is on the speakers’ bureau and received grants from Biotest. He is on the speakers’ bureau for BioMarin, CSL Behring, Falk Foundation, and Olink. He received grants from AbbVie. Katja Deterding advises, is on the speakers’ bureau, and received grants from Gilead. Thomas Reiberger consults and advises AbbVie, AstraZeneca, Bayer, Boehringer-Ingelheim, Gilead, Intercept/Advanz, MSD, Resolution, and Siemens. He received grants from AbbVie, Boehringer-Ingelheim, Dr. Falk Pharma, Gilead, W. L. Gore, Intercept/Advanz, MSD, Myr, Philips Healthcare, Pliant, Roche, and Siemens. He is on the speakers’ bureau for AbbVie, Gilead, W. L. Gore, Intercept/Advanz Pharma, MSD, and Roche. Pietro Lampertico advises and is on the speakers’ bureau for AbbVie, Aligos, Alnylam, Altona, Antios, Arrowhead, Bristol Myer Squibb, Eiger, Gilead, GlaxoSmithKline, Grifols, Janssen, MSD, MYR, Roboscreen, Roche, and Vir. The remaining authors have no conflicts to report.
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