Papatheodoridi Margarita, Sevastianos Vasilios, Zachou Kalliopi, Christodoulou Dimitrios, Koskinas John, Deutsch Melanie, Alexopoulou Alexandra, Elefsiniotis Ioannis, Triantos Christos, Gigi Elena, Androutsakos Theodoros, Karagiannakis Dimitrios, Mani Iliana, Dimitroulopoulos Dimitrios, Mela Maria, Sinakos Emmanouil, Michopoulos Spyros, Mimidis Konstantinos, Papadopoulos Nikolaos, Kontos Athanasios, Veretanos Christos, Lymperopoulos Dimitrios, Giannoulis George, Papadimitropoulos Vasilios, Avramopoulou Evdoxia, Papatheodoridi Alkistis, Pantzios Spyridon, Vasilieva Larisa, Kranidioti Hariklia, Koullias Emmanouil, Psychos Nikolaos, Fytili Paraskevi, Vlachogiannakos John, Cholongitas Evangelos, Manolakopoulos Spilios, Goulis Ioannis, Dalekos George, Papatheodoridis George
General Hospital of Athens "Laiko", Medical School of National and Kapodistrian University of Athens, Athens, Greece.
General Hospital of Athens "Evangelismos", Athens, Greece.
Liver Int. 2025 Jul;45(7):e70151. doi: 10.1111/liv.70151.
The data of this study can be available from the corresponding author upon reasonable request.
BACKGROUND & AIMS: There is still limited real-life data for bulevirtide (BLV) therapy in chronic hepatitis D (CHD). We assessed the efficacy and safety of up to 2-year BLV therapy in CHD patients treated at Greek centres.
All patients with CHD starting BLV 2 mg before the approvals of the HERACLIS_BLV_D study were included. All patients were followed according to standard clinical practice. Serum HDV RNA was determined by a polymerase chain reaction assay at a central lab. Virological response (VR) was defined as HDV RNA undetectable or decline > 2 log compared to baseline. Biochemical response (BR) was defined as normal ALT.
Seventy-six patients were included (45 with cirrhosis). At 12 and 24 months, rates of VR were 73% and 93%, HDV DNA undetectability 57% and 80.4%, BR 71% and 74%, and combined response (VR + BR) 51% and 74%, respectively. VR response at month 24 was associated with no baseline characteristic, while 24-month HDV RNA undetectability was independently associated with lower baseline HDV RNA (p = 0.019) and platelets (p = 0.045). Both 24-month BR and combined responses were independently associated with lower baseline gamma-glutamyl transpeptidase (p = 0.004) and haemoglobin levels (p = 0.006). There was no drug-related serious adverse event and no patient discontinued BLV due to an adverse event.
BLV monotherapy is safe and effective for the treatment of CHD patients followed at Greek tertiary liver centres offering increasing rates of VRHDV RNA undetectability and BR or combined response exceeding 90%, 80% and 70%, respectively, at 2 years of therapy.
本研究的数据可在合理请求下从通讯作者处获取。
关于布列韦肽（BLV）治疗慢性丁型肝炎（CHD）的实际临床数据仍然有限。我们评估了在希腊各中心接受治疗的CHD患者接受长达2年BLV治疗的疗效和安全性。
纳入所有在HERACLIS_BLV_D研究获批前开始使用2mg BLV的CHD患者。所有患者均按照标准临床实践进行随访。血清HDV RNA由中心实验室通过聚合酶链反应测定法测定。病毒学应答（VR）定义为HDV RNA检测不到或较基线下降>2 log。生化应答（BR）定义为ALT正常。
共纳入76例患者（45例伴有肝硬化）。在12个月和24个月时，VR发生率分别为73%和93%，HDV DNA检测不到率分别为57%和80.4%，BR分别为71%和74%，联合应答（VR+BR）分别为51%和74%。24个月时的VR应答与任何基线特征均无关，而24个月时HDV RNA检测不到与较低的基线HDV RNA（p=0.019）和血小板（p=0.045）独立相关。24个月时的BR和联合应答均与较低的基线γ-谷氨酰转肽酶（p=0.004）和血红蛋白水平（p=0.006）独立相关。未发生与药物相关的严重不良事件，也没有患者因不良事件而停用BLV。
在希腊三级肝病中心接受治疗的CHD患者中，BLV单药治疗安全有效，在治疗2年时，VR、HDV RNA检测不到率以及BR或联合应答率分别超过90%、80%和70%。
