Long-Term Treatment with Bulevirtide in Patients with Chronic Hepatitis D and Advanced Chronic Liver Disease

Bulevirtide (BLV) is approved for the treatment of chronic hepatitis D (CHD). Because only limited long-term experience has been reported, we aimed to evaluate the efficacy and safety of BLV treatment in patients with advanced chronic liver disease (ACLD). We performed a retrospective analysis of pa...

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Main Authors: Ayaz Sapuk, Leonie Steinhoff, Kristin Hünninghaus, Katharina Willuweit, Jassin Rashidi Alavijeh, Benedikt Hild, Lucia Asar, Hartmut H. Schmidt, Christoph Schramm
Format: Article
Language:English
Published: Wiley 2024-01-01
Series:Canadian Journal of Gastroenterology and Hepatology
Online Access:http://dx.doi.org/10.1155/2024/2364031
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author Ayaz Sapuk
Leonie Steinhoff
Kristin Hünninghaus
Katharina Willuweit
Jassin Rashidi Alavijeh
Benedikt Hild
Lucia Asar
Hartmut H. Schmidt
Christoph Schramm
author_facet Ayaz Sapuk
Leonie Steinhoff
Kristin Hünninghaus
Katharina Willuweit
Jassin Rashidi Alavijeh
Benedikt Hild
Lucia Asar
Hartmut H. Schmidt
Christoph Schramm
author_sort Ayaz Sapuk
collection DOAJ
description Bulevirtide (BLV) is approved for the treatment of chronic hepatitis D (CHD). Because only limited long-term experience has been reported, we aimed to evaluate the efficacy and safety of BLV treatment in patients with advanced chronic liver disease (ACLD). We performed a retrospective analysis of patients with CHD who received BLV 2 mg/day for >12 months at a tertiary center. Virological response (VR) was defined as a reduction in hepatitis delta virus-ribonucleic acid (HDV-RNA) ≥2 log10 from baseline or HDV-RNA negativity and biochemical response (BR) as gender-specific normalization of transaminases. We identified 14 patients (9 men, 5 women; median age of 48 years; interquartile range (IQR) of 37–55), of whom 12 (86%) had suggested or assumed ACLD according to Baveno VI criteria. The median duration of BLV treatment was 26 months (IQR 17–27). During treatment, the mean HDV-RNA level decreased from log10 5.58 IU/ml to levels between log10 2.19 IU/ml and log10 3.19 IU/ml. HDV-RNA negativity was achieved in up to 63% after 24 months. VR and BR were 86% and 43% after 12 months, 90% and 60% after 18 months, 75% and 75% after 24 months, and 100% and 50% after 30 months, respectively. Two nonpersisting viral breakthroughs were observed after 24 months of treatment. The Child Pugh score and model of end-stage liver disease (MELD) scores remained stable or improved in 12 patients (86%). Only one patient developed hepatic decompensation after 24 months of treatment with ascites requiring large-volume paracentesis which was not associated with viral breakthrough, portal vein thrombosis, or hepatocellular carcinoma. Treatment with BLV beyond one year is effective and safe for patients with CHD and ACLD. Liver function remained stable or improved during treatment in the vast majority of patients, and only one case of hepatic decompensation occurred during a median follow-up of 26 months.
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spelling doaj-art-9d99b582b695458a9d1559cc5ee2ebc62025-08-20T03:45:10ZengWileyCanadian Journal of Gastroenterology and Hepatology2291-27972024-01-01202410.1155/2024/2364031Long-Term Treatment with Bulevirtide in Patients with Chronic Hepatitis D and Advanced Chronic Liver DiseaseAyaz Sapuk0Leonie Steinhoff1Kristin Hünninghaus2Katharina Willuweit3Jassin Rashidi Alavijeh4Benedikt Hild5Lucia Asar6Hartmut H. Schmidt7Christoph Schramm8Department of Gastroenterology, Hepatology and Transplantational MedicineDepartment of Gastroenterology, Hepatology and Transplantational MedicineDepartment of Gastroenterology, Hepatology and Transplantational MedicineDepartment of Gastroenterology, Hepatology and Transplantational MedicineDepartment of Gastroenterology, Hepatology and Transplantational MedicineDepartment of Gastroenterology, Hepatology and Transplantational MedicineInstitute for VirologyDepartment of Gastroenterology, Hepatology and Transplantational MedicineDepartment of Gastroenterology, Hepatology and Transplantational MedicineBulevirtide (BLV) is approved for the treatment of chronic hepatitis D (CHD). Because only limited long-term experience has been reported, we aimed to evaluate the efficacy and safety of BLV treatment in patients with advanced chronic liver disease (ACLD). We performed a retrospective analysis of patients with CHD who received BLV 2 mg/day for >12 months at a tertiary center. Virological response (VR) was defined as a reduction in hepatitis delta virus-ribonucleic acid (HDV-RNA) ≥2 log10 from baseline or HDV-RNA negativity and biochemical response (BR) as gender-specific normalization of transaminases. We identified 14 patients (9 men, 5 women; median age of 48 years; interquartile range (IQR) of 37–55), of whom 12 (86%) had suggested or assumed ACLD according to Baveno VI criteria. The median duration of BLV treatment was 26 months (IQR 17–27). During treatment, the mean HDV-RNA level decreased from log10 5.58 IU/ml to levels between log10 2.19 IU/ml and log10 3.19 IU/ml. HDV-RNA negativity was achieved in up to 63% after 24 months. VR and BR were 86% and 43% after 12 months, 90% and 60% after 18 months, 75% and 75% after 24 months, and 100% and 50% after 30 months, respectively. Two nonpersisting viral breakthroughs were observed after 24 months of treatment. The Child Pugh score and model of end-stage liver disease (MELD) scores remained stable or improved in 12 patients (86%). Only one patient developed hepatic decompensation after 24 months of treatment with ascites requiring large-volume paracentesis which was not associated with viral breakthrough, portal vein thrombosis, or hepatocellular carcinoma. Treatment with BLV beyond one year is effective and safe for patients with CHD and ACLD. Liver function remained stable or improved during treatment in the vast majority of patients, and only one case of hepatic decompensation occurred during a median follow-up of 26 months.http://dx.doi.org/10.1155/2024/2364031
spellingShingle Ayaz Sapuk
Leonie Steinhoff
Kristin Hünninghaus
Katharina Willuweit
Jassin Rashidi Alavijeh
Benedikt Hild
Lucia Asar
Hartmut H. Schmidt
Christoph Schramm
Long-Term Treatment with Bulevirtide in Patients with Chronic Hepatitis D and Advanced Chronic Liver Disease
Canadian Journal of Gastroenterology and Hepatology
title Long-Term Treatment with Bulevirtide in Patients with Chronic Hepatitis D and Advanced Chronic Liver Disease
title_full Long-Term Treatment with Bulevirtide in Patients with Chronic Hepatitis D and Advanced Chronic Liver Disease
title_fullStr Long-Term Treatment with Bulevirtide in Patients with Chronic Hepatitis D and Advanced Chronic Liver Disease
title_full_unstemmed Long-Term Treatment with Bulevirtide in Patients with Chronic Hepatitis D and Advanced Chronic Liver Disease
title_short Long-Term Treatment with Bulevirtide in Patients with Chronic Hepatitis D and Advanced Chronic Liver Disease
title_sort long term treatment with bulevirtide in patients with chronic hepatitis d and advanced chronic liver disease
url http://dx.doi.org/10.1155/2024/2364031
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