Department of Gastroenterology, Hepatology and Transplantational Medicine University Hospital Essen, and Faculty of Medicine University of Duisburg-Essen, Essen, Germany.
Institute for Virology University Hospital Essen, and Faculty of Medicine University of Duisburg-Essen, Essen, Germany.
Can J Gastroenterol Hepatol. 2024 Jul 23;2024:2364031. doi: 10.1155/2024/2364031. eCollection 2024.
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 log 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 log 5.58 IU/ml to levels between log 2.19 IU/ml and log 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.
布乐维替德 (BLV) 获批用于治疗慢性丁型肝炎 (CHD)。由于仅报告了有限的长期经验，我们旨在评估 BLV 治疗在晚期慢性肝病 (ACLD) 患者中的疗效和安全性。我们在一家三级中心对接受 BLV 2mg/天治疗超过 12 个月的 CHD 患者进行了回顾性分析。病毒学应答 (VR) 定义为基线时乙型肝炎 delta 病毒核糖核酸 (HDV-RNA) 降低≥2 对数或 HDV-RNA 阴性，生化应答 (BR) 定义为性别特异性转氨酶正常化。我们确定了 14 名患者（9 名男性，5 名女性；中位年龄 48 岁；四分位距 [IQR] 37-55），其中 12 名（86%）根据 Baveno VI 标准提示或假定为 ACLD。BLV 治疗的中位持续时间为 26 个月（IQR 17-27）。在治疗过程中，HDV-RNA 水平从 log5.58IU/ml 均值下降至 log2.19IU/ml 和 log3.19IU/ml 之间。在 24 个月时，多达 63%的患者实现了 HDV-RNA 阴性。12 个月时 VR 和 BR 分别为 86%和 43%，18 个月时分别为 90%和 60%，24 个月时分别为 75%和 75%，30 个月时分别为 100%和 50%。在治疗 24 个月后观察到 2 例非持续性病毒突破。12 名患者（86%）的 Child-Pugh 评分和终末期肝病模型 (MELD) 评分保持稳定或改善。仅有 1 名患者在治疗 24 个月后出现腹水需要大量腹腔穿刺术的肝失代偿，与病毒突破、门静脉血栓形成或肝细胞癌无关。对于 CHD 和 ACLD 患者，BLV 治疗超过 1 年是有效且安全的。在大多数患者中，治疗期间肝功能保持稳定或改善，仅有 1 例肝失代偿发生在中位随访 26 个月时。
