Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.
CRC "A. M. and A. Migliavacca" Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
J Viral Hepat. 2023 Apr;30 Suppl 1:26-32. doi: 10.1111/jvh.13811. Epub 2023 Feb 27.
Chronic hepatitis Delta (CHD) is a rare and severe form of chronic viral hepatitis. Until recently, the only therapeutic approach has been the off-label use of a 48 weeks course of PegInterferon alpha (PegIFNα), that was characterized by suboptimal efficacy and burdened by significant side effects that limited treatment applicability in patients with advanced liver disease. In July 2020, European Medicines Agency (EMA) conditionally approved the entry inhibitor Bulevirtde (BLV) at the dose of 2 mg/day for the treatment of adult patients with compensated CHD. Efficacy and safety of BLV in CHD have been evaluated in clinical trials either as monotherapy or in combination with PegIFNα. These results were confirmed by real-life studies, which also evaluated long-term BLV monotherapy in patients with advanced compensated cirrhosis. Notwithstanding these promising results there are still several issues to be addressed, such as the optimal duration of the treatment, the rates of off-therapy responses, as well as the long-term clinical benefits. This review summarizes updated and current literature data about clinical trials and real-life studies with BLV monotherapy and/or in combination with PegIFNα.
慢性乙型肝炎（CHD）是一种罕见且严重的慢性病毒性肝炎。直到最近，唯一的治疗方法是使用未经批准的聚乙二醇干扰素α（PegIFNα）48 周疗程，其疗效并不理想，且副作用明显，限制了其在晚期肝病患者中的应用。2020 年 7 月，欧洲药品管理局（EMA）有条件批准了乙型肝炎病毒进入抑制剂 Bulevirtde（BLV），每日 2mg 剂量用于治疗代偿性 CHD 的成年患者。BLV 在 CHD 中的疗效和安全性已在临床试验中作为单药或与 PegIFNα 联合进行评估。这些结果得到了真实世界研究的证实，这些研究还评估了 BLV 单药治疗晚期代偿性肝硬化患者的长期疗效。尽管这些结果令人鼓舞，但仍有几个问题需要解决，例如最佳治疗持续时间、停药后应答率以及长期临床获益。本综述总结了关于 BLV 单药治疗和/或与 PegIFNα 联合治疗的临床试验和真实世界研究的最新文献数据。
