Antiviral therapy for chronic hepatitis delta: new insights from clinical trials and real-life studies.

For decades, pegylated interferon alpha (PegIFN-α) has represented the only therapeutic option, with limited virological response rates and poor tolerability.

数十年来，聚乙二醇化干扰素α(PegIFN-α)一直是唯一的治疗选择，具有有限的病毒学应答率和较差的耐受性。

In 2020, the European Medicines Agency approved bulevirtide (BLV) at 2 mg/day, an entry inhibitor of hepatitis B virus (HBV)/hepatitis delta virus (HDV), which proved to be safe and effective as a monotherapy for up to 144 weeks in clinical trials and real-life studies, including patients with cirrhosis.

2020年，欧洲药品管理局批准了每日2毫克的Bulevirtide（BLV），这是一种乙型肝炎病毒（HBV）/丙型肝炎病毒（HDV）的进入抑制剂，在临床试验和真实世界研究中，作为单药治疗证明了其安全性和有效性，治疗时间长达144周，包括肝硬化患者。

Long-term BLV monotherapy may reduce decompensating events in patients with cirrhosis.

长期的BLV单药治疗可能会减少肝硬化患者的失代偿事件。

The combination of BLV 2 mg with PegIFN-α increased the HDV RNA undetectability rates on-therapy but not off-therapy, compared with PegIFN monotherapy.

BLV 2 mg与PegIFN-α联合使用增加了治疗期间HDV RNA不可检测率，但停药后未见此效果，与PegIFN单药治疗相比。

However, combination therapy, but not BLV monotherapy, may induce hepatitis B surface antigen (HBsAg) loss in some patients.

然而，联合治疗而非BLV单药治疗，可能在某些患者中诱导乙型肝炎表面抗原（HBsAg）丧失。

The PegIFN lambda study has been discontinued due to liver toxicity issues, while lonafarnib boosted with ritonavir showed limited off-therapy efficacy in a phase 3 study.

由于肝毒性问题，PegIFN lambda研究已被终止，而在一项III期研究中，与利托那韦联合增强的lonafarnib在停药后的疗效有限。

Nucleic acid polymer-based therapy is promising but large studies are still lacking.

基于核酸聚合物的疗法前景广阔，但大规模研究仍然不足。

New controlled trial data come from molecules, such as monoclonal antibodies and/or small interfering RNA, that target HBsAg or HBV RNAs, which demonstrated not only profound HDV suppression, but also HBsAg decline.While waiting for new compounds to be approved as monotherapy or in combination, BLV monotherapy 2 mg/day remains the only approved therapy for CHD, at least in the European Union region.

新的对照试验数据来自靶向HBsAg或HBV RNA的分子，如单克隆抗体和/或小干扰RNA，这些分子不仅显著抑制HDV，还导致HBsAg下降。在等待新化合物作为单药或联合疗法获批的同时，BLV单药疗法2 mg/天仍然是至少在欧盟地区唯一批准的CHD疗法。