Endpoints of hepatitis B treatment

The goal of hepatitis B treatment is to prevent the development of cirrhosis, liver failure, and hepatocellular carcinoma. Ideally, clinical studies should demonstrate that hepatitis B therapies can prevent liver‐related complications; however, these clinical endpoints evolve over years or decades....

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Bibliographic Details
Published in:Journal of viral hepatitis 2010-10, Vol.17 (10), p.675-684
Main Authors: Chotiyaputta, W., Lok, A. S. F.
Format: Article
Language:English
Subjects:
alanine aminotransferase
Biomarkers
Carcinoma, Hepatocellular - prevention & control
Clinical Trials as Topic
HBeAg seroconversion
HBsAg loss
HBV DNA
Hepatitis B - complications
Hepatitis B - drug therapy
Humans
Liver Cirrhosis - prevention & control
Liver Failure - prevention & control
liver histology
Liver Neoplasms - prevention & control
Treatment Outcome
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Summary:The goal of hepatitis B treatment is to prevent the development of cirrhosis, liver failure, and hepatocellular carcinoma. Ideally, clinical studies should demonstrate that hepatitis B therapies can prevent liver‐related complications; however, these clinical endpoints evolve over years or decades. Therefore, clinical trials have relied on intermediate endpoints to evaluate the efficacy of treatment and to determine when treatment can be stopped. Intermediate endpoints that have been used include biochemical, histological, virological, and serological endpoints. This review will discuss the validity of these intermediate endpoints as surrogates of clinical endpoints, and the rates at which these intermediate endpoints can be achieved with currently available therapies.
ISSN:1352-0504
1365-2893
DOI:10.1111/j.1365-2893.2010.01369.x