一个第3期,随机试验的布莱维尔提德在慢性肝炎D
Heiner Wedemeyer1, Soo Aleman1, Maurizia Rossana Brunetto1
1From Medizinische Hochschule Hannover, Excellence Cluster RESIST, and D-SOLVE Consortium (H.W., M.C.), Hannover, German Center for Infection Research (DZIF) Partner Site Hannover-Braunschweig, Braunschweig (H.W., M.C.), Clinical Pharmacology and Pharmacoepidemiology and DZIF Partner Site Heidelberg (A. Blank) and the Department of Internal Medicine IV (U.M.), Heidelberg University Hospital, Heidelberg, the Institute of Medical Virology (A. Berger, S.C.), the Department of Internal Medicine, University Hospital Frankfurt (S.Z.), DZIF (S.C.), and Fraunhofer Institute for Translational Medicine and Pharmacology ITMP (S.C.), Frankfurt, and Universitätsklinikum Hamburg-Eppendorf, Medizinische Klinik, and DZIF, Hamburg-Lübeck-Borstel-Riems, Hamburg (J.S.W.) - all in Germany; the Department of Infectious Diseases, Karolinska University Hospital, Karolinska Institutet, Stockholm (S.A.); the Department of Clinical and Experimental Medicine, University of Pisa, and the Hepatology Unit, Pisa University Hospital, Pisa (M.R.B.), the Division of Internal Medicine, University of Modena and Reggio Emilia, Modena (P.A.), and the Division of Gastroenterology and Hepatology, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, CRC "A. M. and A. Migliavacca" Center for Liver Disease, and the Department of Pathophysiology and Transplantation, University of Milan, Milan (P.L.) - all in Italy; M.F. Vladimirsky Moscow Regional Research and Clinical Institute (P.B.), National Medical Research Center of Tuberculosis and Infectious Diseases, Ministry of Health (V.C.), Sechenov University (V.C.), and the Clinic of Modern Medicine (T.S.), Moscow, the National Medical Research Center of Physiopulmonology and Infectious Diseases, Yekaterinburg (N.M.), Stavropol Regional Clinical Hospital, Stavropol (N.G.), Hepatolog, Samara (V.M.), and Southern Ural State Medical University, Chelyabinsk (O.S.) - all in Russia; and Gilead Sciences, Foster City, CA (D.M., V.S., Q.A., B.D., J.F., A.O., Y.L.).
在患有慢性肝炎D的患者中,布列维尔提德显著降低了肝炎D病毒RNA,并使氨酸转移酶水平正常化.这种治疗对管理这种晚期肝病有希望.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 病毒学 病毒学
- 临床试验 临床试验
背景情况:
- 与乙型肝炎病毒 (HDV) 的同时感染加快了慢性乙型肝炎患者的肝病进展.
- 布列维尔提德是HDV进入肝细胞的抑制剂.
研究的目的:
- 为了评估布莱维尔提德在慢性肝炎D患者的疗效和安全性.
- 评估布莱维对HDVRNA水平和肝酶正常化的影响.
主要方法:
- 第三期随机试验涉及慢性肝炎D患者.
- 患者在48周内接受布莱维尔提德 (每天2毫克或10毫克) 或不接受治疗.
- 主要终点:无法检测的HDVRNA或≥2 log10 IU/mL的减少加上在48周的正常化氨酸转移酶 (ALT).
主要成果:
- 在2毫克和10毫克布莱维尔提德组中的45%和48%的患者分别实现了主要终点,而对照组的2% (P<0.001).
- 在51% (2mg) 和56% (10mg) 的患者中发生ALT正常化,明显高于对照组 (12%).
- 没有观察到乙型肝炎表面抗原 (HBsAg) 的损失;常见的不良反应包括头痛和疲劳. 没有报告与治疗相关的严重不良事件.
结论:
- 在患有慢性肝炎D的患者中,48周的布莱维尔提德治疗有效降低了HDVRNA和正常化的ALT水平.
- 这项研究支持布莱维尔提德作为慢性肝炎D的潜在治疗选择.
- 目前正在进行进一步的随访,以评估长期的疗效和安全性.


