ABSTRACT
Approximately 400 million individuals worldwide have developed chronic hepatitis B
after exposure to the hepatitis B virus (HBV). Up to 40% of these will eventually
develop serious hepatic complications. Although widespread immunization, improved
blood supply testing, and emphasis on safe sex have significantly decreased new HBV
infections, the large reservoir of infected individuals (400 million) remains a serious
health problem. At present, only two agents are available for the treatment of chronic
hepatitis B: interferon alfa and lamivudine. Both are associated with important limitations
of efficacy or safety, or both. These limitations and other problems associated with
the evaluation of current and investigational therapies for chronic hepatitis B give
rise to several key issues in management of HBV: duration of therapy, goals of therapy,
need for standardization of the measurement of clinical responses, and definitions
of response to therapy. The last two of these key issues are of particular concern.
The lack of similarity in study designs, the use of inconsistent definitions of and
criteria for therapeutic response, and the lack of uniformity in assays to detect
HBV DNA titers hamper consistent evaluations of treatment. Therefore, there is a need
for the scientific community to standardize the measures of performance and methods
of analysis and reporting of clinical trials for current and new drugs.
KEYWORDS
Interferon - lamivudine - seroconversion - standardization of response - HBV DNA assay
