Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy

Abstract

This study was conducted to evaluate the durability of clevudine-induced viral response after the withdrawal of treatment. 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. 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. The clevudine-induced viral response was durable in the majority of patients for 2 years after the withdrawal of treatment.