Antiviral therapy for chronic hepatitis B: are we doing any good to patients?

At the recent National Institutes of Health Consensus Development Conference, the value of antiviral therapy for chronic hepatitis B in improving clinical outcome was hotly debated. In patients with chronic hepatitis B, antiviral therapy has proved effective in viral load reduction, alanine aminotransferase normalization and histological improvements. However, its efficacy in reducing decompensated liver disease, hepatocellular carcinoma and liver-related death remains unclear. To date, animal studies and observational studies, but very few randomized controlled trials, have shown improved clinical outcomes after antiviral therapy. The difficulties of conducting clinical trials using clinical endpoints are highlighted. Before more clinical outcome data are available, it is important to validate the clinical implications of surrogate markers including biochemical, virological and histological responses.