慢性乙型肝炎抗病毒治疗药物临床试验技术指导原则专家意见

Expert consensus on the detection and clinical application of HBV RNA in serum of patients with chronic HBV infection

慢性乙型肝炎(CHB)是影响我国公众健康的重要问题之一。现有乙型肝炎抗病毒药物,包括核苷(酸)类似物和干扰素,可有效抑制病毒复制、控制CHB患者疾病进展,但难以彻底清除病毒或实现CHB功能性治愈(临床治愈),这一未被满足的临床需求正是CHB抗病毒治疗新药研发的主要目标。本指导原则主要介绍和讨论新药临床试验的设计及需要重点关注的问题,旨在为治疗CHB新药临床试验的设计、实施和评价提供技术指导。

Since the discovery of circulating hepatitis B virus(HBV)RNA in the peripheral blood of patients with chronic hepatitis B in 1996,a growing number of studies have focused on clarifying the biological characteristics and clinical application value of serum HBV RNA.This consensus summarizes the research progress of serum HBV RNA existing profiles,quantitative detection methods and current clinical applications,and puts forward suggestions on quantitative detection target areas,detection results and clinical applications,in order to better apply this indicator for the clinical management of patients with chronic hepatitis B infection.