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J Hepatol. 2012 Dec;57(6):1326-35. doi: 10.1016/j.jhep.2012.06.025. Epub 2012 Jun 28.

Assessing long-term treatment efficacy in chronic hepatitis B and C: between evidence and common sense.

Author information

1
Department of Medicine, A.M. Migliavacca Center for Liver Diseases and First Division of Gastroenterology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.

Abstract

Chronic infection with the hepatitis B and C virus represents a major health problem worldwide, as it is estimated that roughly 400 and 200 million people respectively, are infected by each virus. By definition, any antiviral therapy that claims to be effective should have as its ultimate efficacy end point an improvement in patients' survival, or at least a reduction in the development rates of liver-related complications. However, this is extremely complicated to prove as the natural course of both viral diseases is extremely slow, requiring decades to evolve in cirrhosis and even more years to lead to liver complications. For this reason, clinicians and health authorities have relied on so called surrogate end points to assess the efficacy of any therapeutic intervention for viral hepatitis. Obviously, this allows for standardization in study designs that ultimately translates into an accelerated time frame for therapeutic drugs as well as healthcare innovations to enter the viral hepatitis clinical practice. However, it also calls for demonstration that surrogate end points in the treatment of patients with chronic hepatitis B or C are good and reliable markers of long-term efficacy.

PMID:
22750749
DOI:
10.1016/j.jhep.2012.06.025
[Indexed for MEDLINE]
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