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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Acknowledgments
This study was sponsored by Bukwang Pharmaceutical Co. Ltd and in part by the Korea Health 21 R&D Project, Ministry of Health and Welfare, Republic of Korea (Grant No. 02-PJ2-PG4-PT01-0034).
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Lee, HS., Yoo, B.C., Lee, K.S. et al. Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy. J Gastroenterol 46, 410–414 (2011). https://doi.org/10.1007/s00535-010-0354-x
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DOI: https://doi.org/10.1007/s00535-010-0354-x