End points of therapy in chronic hepatitis B.

ABSTRACT

This review assesses the relevance of the clinical, histological, biochemical and virological end points in the course and outcome of chronic hepatitis B. The pathway and the impact of the variation in these end points are presented, as well as their definitions. The treatment goals are discussed in terms of quality of life and survival. Prevention of the progression of the disease to cirrhosis, decompensated cirrhosis, end-stage liver disease and hepatocellular carcinoma seems to be the best approach to improve survival. As these criteria are long-term end points, easier to use end points assessed in clinical trials as efficacy objectives were also analyzed to determine whether they can be used as accurate surrogate criteria. Results of therapy were then analyzed according to the approved end points and in terms of management of chronic hepatitis B. Finally, an attempt to define new clinical end points is discussed in view of the development of more potent antiviral strategies.