Clinical studies of new antiviral drugs for chronic hepatitis B
DOI:10.3969/j.issn.1001-5256.2021.05.003
- VernacularTitle:慢性乙型肝炎抗病毒新药的临床研究
- Author:
Hong ZHANG
1
;
Xiaoxue ZHU
;
Jiajia MAI
;
Hong CHEN
;
Jing ZHOU
;
Yue HU
;
Jia XU
;
Yanhua DING
Author Information
1. Ward of Phase I Clinical Trial, The First Hospital of Jilin University, Changchun 130021, China
- Publication Type:Research Article
- Keywords:
Hepatitis B, Chronic;
Clinical Trial;
Drug Therapy
- From:
Journal of Clinical Hepatology
2021;37(5):1006-1010.
- CountryChina
- Language:Chinese
-
Abstract:
Hepatitis B virus (HBV) infection is a major global public health issue. Clinical cure (also known as functional cure) of chronic hepatitis B (CHB) is the ideal therapeutic goal recommended by the latest guidelines for the prevention and treatment of CHB in China and globally. Optimized treatment regimens with direct-acting antiviral agents ［e.g., nucleos(t)ide analogues］ or immunomodulators (e.g., pegylated interferon-α) sequentially or in combination tend to have low cure rates. Rapid development has been achieved in the research and development of drugs for the treatment of CHB. This article reviews the clinical study of new antiviral drugs for CHB, including the selection of subjects, study design, dosage, dose escalation, adverse events, and efficacy evaluation. It is necessary to introduce the knowledge of quantitative pharmacology to analyze the association of drug exposure in body with efficacy and adverse reactions, and exploratory indicators should be incorporated for comprehensive analysis. This review provides related experience and new ideas for the clinical research and development of new anti-HBV drugs.
