Herta Toni, Hahn Magdalena, Maier Melanie, Fischer Janett, Niemeyer Johannes, Hönemann Mario, Böhlig Albrecht, Gerhardt Florian, Schindler Aaron, Schumacher Jonas, Berg Thomas, Wiegand Johannes, van Bömmel Florian
Division of Hepatology, Department of Medicine II, Leipzig University Medical Center, 04103 Leipzig, Germany.
Institute of Medical Microbiology and Virology, Leipzig University Medical Center, 04103 Leipzig, Germany.
Pathogens. 2022 Apr 27;11(5):517. doi: 10.3390/pathogens11050517.
Background: The hepatitis B and D virus (HBV/HDV) hepatocyte entry inhibitor bulevirtide (BLV) has been available in Europe since July 2020, after the registrational trial MYR202. Real-life data on the efficacy and safety of BLV are sparse. Methods: We have analysed the course of treatment with BLV (2 mg/day) plus tenofovir disoproxil fumarate (TDF) (245 mg/day) in patients with chronic hepatitis delta (CHD). Virologic (≥2 log reduction in HDV RNA or suppression of HDV RNA below the lower limit of detection) and biochemical (normalisation of serum ALT) treatment responses after 24 weeks were defined according to the MYR202 trial. Results: Seven patients were recruited (four with liver cirrhosis Child−Pugh A). After 24 weeks, a virologic response was observed in five of seven and a biochemical response was seen in three of six patients with elevated serum ALT at baseline. Extended treatment data > 48 weeks were available in three cases: two presented with continuous virologic and biochemical responses and in one individual an HDV-RNA breakthrough was observed. Adverse effects were not recorded. Conclusions: The first real-life data of the approved dosage of 2 mg of BLV in combination with TDF confirm the safety, tolerability, and efficacy of the registrational trial MYR202 for a treatment period of 24 weeks and beyond.
自2020年7月注册试验MYR202完成后，乙肝和丁型肝炎病毒（HBV/HDV）肝细胞进入抑制剂布列韦肽（BLV）在欧洲上市。关于BLV疗效和安全性的真实世界数据稀少。方法：我们分析了慢性丁型肝炎（CHD）患者使用BLV（2毫克/天）联合替诺福韦酯（TDF）（245毫克/天）的治疗过程。根据MYR202试验定义24周后的病毒学（HDV RNA降低≥2 log或HDV RNA抑制至检测下限以下）和生化（血清ALT正常化）治疗反应。结果：招募了7名患者（4名Child-Pugh A级肝硬化患者）。24周后，7名患者中有5名出现病毒学反应，基线时血清ALT升高的6名患者中有3名出现生化反应。3例患者有超过48周的延长治疗数据：2例呈现持续的病毒学和生化反应，1例观察到HDV-RNA突破。未记录到不良反应。结论：2毫克BLV联合TDF批准剂量的首批真实世界数据证实了注册试验MYR202在24周及更长治疗期的安全性、耐受性和疗效。
