Clinical trials considerations for patients with immune-tolerant phase chronic hepatitis B
10.3760/cma.j.cn501113-20211220-00606
- VernacularTitle:慢性乙型肝炎免疫耐受期患者的临床试验思考
- Author:
Shuning ZUO
1
;
Jianzhong ZHAO
Author Information
1. 国家药品监督管理局 药品审评中心，北京 100022
- Keywords:
Immunological tolerance;
New drug;
Clinical trial
- From:
Chinese Journal of Hepatology
2022;30(5):559-563
- CountryChina
- Language:Chinese
-
Abstract:
Most patients with early stage chronic hepatitis B virus infection are in the immune-tolerant phase. Therefore, previously been generally believed that there is no disease progression or liver injury-related events, and poor antiviral efficacy in patients with immune-tolerant phase. With that in mind, antiviral therapy is generally not recommended in current domestic and foreign guidelines. However, more and more studies have shown that patients in the immune-tolerant phase may develop liver cirrhosis and hepatocellular carcinoma without treatment, so clinical treatment is urgently needed. Currently, drugs based on nucleocapsid inhibitor, immune modulation, and other novel mechanisms for viral replication are being developed to reduce hepatitis B surface antigen, which offers the possibility to achieve viral suppression or even functional cure in these patients. This paper mainly reviews and discusses the latest research progress, population characteristics, treatment needs, and design strategies of clinical trials of new drug for immune-tolerant phase population.
