Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy
Journal of gastroenterology(2010)
Abstract
Background This study was conducted to evaluate the durability of clevudine-induced viral response after the withdrawal of treatment. Methods Patients who showed a complete response [alanine aminotransferase (ALT) normalization and hepatitis B virus (HBV) DNA <4,700 copies/mL for hepatitis B envelope antigen (HBeAg)-negative patients; ALT normalization, HBV DNA <4,700 copies/mL, and HBeAg seroconversion for HBeAg-positive patients] in the previous clevudine phase III trials were followed for an additional 96 weeks without any treatment for hepatitis B. Results Of the 63 patients in the study cohort, 73% and 35% of the patients had HBV DNA <141,500 and <4,700 copies/mL, respectively, and 75% of the patients had normal ALT at the end of follow-up. HBeAg seroconversion was maintained in 81% of the patients and hepatitis B surface antigen (HBsAg) loss occurred in 3 patients. Continued HBsAg titer decrease (−0.5 log IU/mL) was observed in the sustained viral responders, suggesting the reduction of covalently closed circular DNA in hepatocytes. Conclusions The clevudine-induced viral response was durable in the majority of patients for 2 years after the withdrawal of treatment.
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Key words
Hepatitis B virus,HBV DNA,ccc-DNA,HBeAg seroconversion,HBsAg loss
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