丁型病毒性肝炎治疗新药临床研发现状及考量  

Current status and considerations of clinical development of new drugs for the treatment of hepatitis D

作　　者：左书凝 赵建中 ZUO Shu-ning;ZHAO Jian-zhong(Center of Drug Evaluation,National Medical Products Administration,Beijing 100163,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100163

出　　处：《中国临床药理学杂志》2024年第3期464-471,共8页The Chinese Journal of Clinical Pharmacology

摘　　要：相对于乙型病毒性肝炎病毒(HBV)单一感染,HBV/丁型病毒性肝炎病毒(HDV)重叠感染可能与更严重的肝病相关,导致肝硬化、肝细胞癌、肝功能失代偿和肝功能衰竭的发病率增加。慢性HDV感染具有治疗的必要性和急迫性。但目前全球范围内尚无确证安全有效且完全获批用于治疗慢性HDV感染的药物。目前境内外已有多个机制的新药在进行丁型病毒性肝炎临床研发,本文综述目前处于临床研发阶段新药的作用机制、研发进展、临床试验设计,以及目前监管机构、学术界对慢性HDV感染治疗新药临床试验设计的建议,并对确证性临床试验设计要点进行讨论。Relative to hepatitis B virus(HBV) monoinfection,HBV/hepatitis D virus(HDV) co-infection may be associated with more severe liver disease,leading to increased rates of cirrhosis,hepatocellular carcinoma,hepatic decompensation,and liver failure.The treatment of chronic HDV infection is essential and urgent.No drugs with established Efficacy and safety data have been approved for the treatment of chronic HDV infection.There are several new drugs are in clinical development stage now.We review the mechanism of action,research and development progress,and clinical trial design of new drugs currently in the clinical development stage,as well as the recommendations of regulatory agencies and academia for the clinical trial design of new drugs for the treatment of chronic HDV infection.And discuss the key points of confirmatory clinical trial design.

关 键 词：丁型病毒性肝炎病毒 慢性丁型病毒性肝炎 新药研发 临床试验设计 

分 类 号：R97[医药卫生—药品]