[Expert opinions on the technical guiding principles for clinical trials of drugs in the treatment of chronic hepatitis B virus infection].

Abstract

Chronic hepatitis B virus (HBV) infection remains one of the major public health challenges facing our country. There are approximately seventy-five million chronic HBV-infected cases in our country, according to the latest epidemiological data. Current first-line antiviral drugs, including nucleos(t)ide analogs and interferons, can effectively suppress viral replication and delay disease progression, but they still struggle to provide a functional cure for chronic hepatitis B or completely eliminate HBV infection. This unmet clinical need has become the core driving force behind the development of new antiviral drugs for chronic HBV infection. In recent years, China's drug regulatory policy reform has continued to deepen, and the indications for antiviral treatment of HBV infection have been continuously broadened, creating a more favorable policy environment for innovative drug research and development. In this context, global drug development for HBV, especially in China, is accelerating, and new drugs with various mechanisms of action are entering the clinical research phase. In order to standardize and guide the rational design, efficient implementation, and accurate evaluation of clinical trials of new antiviral drugs for the treatment of chronic HBV infection, the expert group combined the latest research progress and clinical practice experience at home and abroad to systematically update key issues such as the research endpoints of clinical trials of new antiviral drugs, aiming to provide authoritative and practical technical guidance for new drug research and development.