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Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy
Authors:Hyo-Suk Lee  Byung Chul Yoo  Kwan Sik Lee  Ju Hyun Kim  Soon-Ho Um  Soo Hyung Ryu  Young-Suk Lee  Young Soo Kim  Kwon Yoo  Joon-Yeol Han  Jae Seok Hwang  Tae-Hun Kim  Jin-Mo Yang  Heon-Ju Lee  Chae Yoon Chon  Mong Cho  Byung Hoon Han  Seong Gyu Hwang  Kwan Soo Byun  Young-Hwa Chung  Se-Hyun Cho  Kwang Cheol Koh  Byung-Ik Kim  Haak Cheoul Kim  Seung Woon Paik  Myung-Seok Lee  Hee-Won Yoo  Cheol Ju Han
Institution:Seoul National University Hospital, Seoul, Korea.
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.
Keywords:
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