Clevudine-induced viral response, associated with continued reduction of HBsAg titer, was durable after the withdrawal of therapy |
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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 |
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Institution: | Seoul National University Hospital, Seoul, Korea. |
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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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