Chronic hepatitis D (CHD) is the most severe form of viral hepatitis, characterised by the greatest increase in risk of cirrhosis, hepatic decompensation and hepatocellular carcinoma. Pegylated-interferon-α (pegIFNα), the only off-label therapeutic option, has been available for the last 30 years but is associated with suboptimal response rates and poor tolerability. Among the new treatment strategies under clinical evaluation, the entry inhibitor bulevirtide (BLV) is the only one that has received conditional approval from the European Medicines Agency (EMA); approval was granted in July 2020 for the treatment of adult patients with compensated CHD at a dose of 2 mg daily. Phase II studies and the week 24 interim analysis of a phase III study demonstrated the efficacy and safety of this treatment as a monotherapy or combined with pegIFNα. This favourable profile has been confirmed by recent real-world studies performed in Europe. As a long-term monotherapy, BLV has been successfully used to treat patients with advanced compensated cirrhosis. These encouraging yet preliminary findings must be viewed with caution as many critical issues related to this new antiviral strategy are still poorly understood, as summarised in this review. While waiting for new anti-HBV and anti-HDV drugs to become available for combination studies, BLV treatment is currently the only available anti-HDV therapeutic option that might improve the long-term prognosis of difficult-to-manage patients with CHD.

慢性丁型肝炎 (CHD) 是最严重的病毒性肝炎，其特征是肝硬化、肝功能失代偿和肝细胞癌的风险增加最大。聚乙二醇化干扰素-α (pegIFNα) 是唯一的标签外治疗选择，在过去 30 年中一直可用，但与次优反应率和耐受性差有关。在临床评估的新治疗策略中，进入抑制剂布列韦肽（BLV）是唯一获得欧洲药品管理局（EMA）有条件批准的药物；2020 年 7 月获得批准，用于治疗成人代偿性冠心病患者，剂量为每天 2 毫克。II 期研究和 III 期研究的第 24 周中期分析证明了这种治疗作为单一疗法或与 pegIFNα 联合治疗的有效性和安全性。最近在欧洲进行的真实世界研究证实了这种有利的情况。作为一种长期的单一疗法，BLV 已成功用于治疗晚期代偿期肝硬化患者。必须谨慎看待这些令人鼓舞但初步的发现，因为与这种新的抗病毒策略相关的许多关键问题仍然知之甚少，正如本综述中所总结的那样。在等待新的抗 HBV 和抗 HDV 药物可用于联合研究的同时，BLV 治疗是目前唯一可用的抗 HDV 治疗选择，可能会改善难治性冠心病患者的长期预后。必须谨慎看待这些令人鼓舞但初步的发现，因为与这种新的抗病毒策略相关的许多关键问题仍然知之甚少，正如本综述中所总结的那样。在等待新的抗 HBV 和抗 HDV 药物可用于联合研究的同时，BLV 治疗是目前唯一可用的抗 HDV 治疗选择，可能会改善难治性冠心病患者的长期预后。必须谨慎看待这些令人鼓舞但初步的发现，因为与这种新的抗病毒策略相关的许多关键问题仍然知之甚少，正如本综述中所总结的那样。在等待新的抗 HBV 和抗 HDV 药物可用于联合研究的同时，BLV 治疗是目前唯一可用的抗 HDV 治疗选择，可能会改善难治性冠心病患者的长期预后。